On March 7, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the fourth quarter and year ended December 31, 2018 (Press release, Calithera Biosciences, MAR 7, 2019, View Source [SID1234534102]). As of December 31, 2018, cash, cash equivalents and investments totaled $136.2 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This is a time of significant progress for Calithera’s clinical development program as we continue to advance our novel onco-metabolism clinical candidates through robust clinical studies," said Susan M. Molineaux, PhD, president and chief executive officer of Calithera. "In the fourth quarter, we broadened development of the novel glutaminase inhibitor telaglenastat through two new clinical trial collaborations with Pfizer. We recently completed enrollment of the ENTRATA trial of telaglenastat for the treatment of patients with renal cell carcinoma. We anticipate that this momentum will continue in 2019 with data from the ENTRATA trial and, with our partner Incyte, data from the INCB001158 program, both expected in the second half of the year."

Fourth Quarter 2018 and Recent Highlights

Completed patient enrollment in the randomized phase 2 ENTRATA trial of telaglenastat (CB-839) and everolimus in renal cell carcinoma (RCC). The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.

Announced two new clinical trial collaborations to evaluate Pfizer’s CDK4/6 inhibitor palbociclib, also known as IBRANCE, and the dual-mechanism poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib also known as TALZENNA, each in combination with Calithera’s glutaminase inhibitor telaglenastat. Preclinical data suggest that telaglenastat synergizes with PARP inhibitors to impair DNA synthesis, enhance DNA damage, and block cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus talazoparib in patients with RCC and TNBC in the first quarter of 2019. Telaglenastat also synergizes with CDK4/6 inhibitors by enhancing cell cycle arrest and blocking cancer cell proliferation. Calithera will initiate a Phase 1/2 clinical trial of the combination of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and patients with KRAS-mutated non-small cell lung cancer (NSCLC) in the second quarter of 2019.

Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from the INCB001158 program are expected to be presented at a medical meeting in the second half of 2019.

Initiated Phase 1 trial of arginase inhibitor CB-280 for the treatment of cystic fibrosis. Arginase is believed to be critical in the pathology of cystic fibrosis. It impairs production of nitric oxide and generates metabolites of arginine that may impair lung function. CB-280 is an orally administered small molecule inhibitor of arginase. The first-in-human Phase 1 trial initiated in February 2019 will evaluate the safety, tolerability and pharmacokinetic profile of oral CB-280 in healthy volunteers. The study will be conducted under a United States Food and Drug Administration (FDA) Investigational New Drug (IND) application.

Initiated IND-enabling studies with CB-708, an oral small molecule CD73 inhibitor. The immuno-oncology target CD73 is an enzyme that plays a critical role in the process of ATP conversion to adenosine. Initiation of a Phase 1 study of CB-708, an orally administered small molecule inhibitor of CD73, is planned for 2019. A preclinical abstract describing CB-708 has been accepted for presentation at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in March.

Selected Fourth Quarter 2018 Financial Results

Cash, cash equivalents and investments totaled $136.2 million at December 31, 2018.

Collaboration revenue for the full year 2018 was $22.2 million, compared with $26.0 million in the prior year. In June 2018, we completed the manufacturing services and technology transfer under our collaboration and license agreement with Incyte, which satisfied the performance obligation under ASC 606, and as a result, all remaining deferred revenue was recognized.

Research and development expenses for the full year 2018 were $66.2 million, compared with $43.1 million in the prior year. The increase of $23.1 million was due to an increase in the telaglenastat program to support our new and ongoing clinical trials, including for our Phase 2 CANTATA trial which opened in 2018, increases in the INCB001158 and CB-280 programs, as well as investment in early stage research. Research and development expenses for the fourth quarter of 2018 were $17.0 million, compared to $15.5 million for the same period last year.

General and administrative expenses for the full year 2018 were $13.3 million, compared with $12.5 million in the prior year. The increase of $0.8 million in 2018 was primarily due to higher personnel-related costs to support our clinical trials, offset partially by lower outside professional services, including activities related to our Incyte collaboration and license agreement and sublease in 2017. General and administrative expenses for the fourth quarter of 2018 were $3.2 million, compared to $3.3 million for the same period last year.

Interest Income, net for the full year 2018 was $2.7 million, compared with $1.9 million in the prior year. The increase of $0.8 million related to higher returns on our investments, partially offset by lower cash equivalents and investment balances. Interest income, net for the fourth quarter of 2018 was $0.7 million, compared to $0.6 million for the same period last year.

Net loss from operations for the three months and year ended December 31, 2018 was $19.5 million and $54.6 million, respectively.

Conference Call Information

Calithera will host an update conference call today, Thursday, March 7th at 4:30 p.m. Eastern Time/ 1:30 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international), and referring to conference ID 9577446. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.

On March 7, 2019 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present a company overview at the Cowen & Company 39th Annual Health Care Conference on Wednesday, March 13, 2019 at 11:20 am ET at the Marriott Copley Place in Boston (Press release, Alnylam, MAR 7, 2019, View Source [SID1234534171]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after the event.

On March 7, 2019 Helix BioPharma Corp. (TSX: HBP), (FSE: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, is reported the first patient has been successfully dosed with L-DOS47, vinorelbine and cisplatin in its Phase IIB, open-label, randomized study in metastatic lung adenocarcinoma patients (LDOS003 study) (Press release, Helix BioPharma, MAR 7, 2019, View Source [SID1234536458]). The goals of the study are to compare the safety, tolerability and preliminary efficacy of L-DOS47 in combination with vinorelbine/cisplatin as compared to vinorelbine/cisplatin alone, in patients with lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The LDOS003 study involves two parts: In Part 1 of the study (dose escalation), patients in cohorts will receive escalating amount of L-DOS47 in combination with vinorelbine/cisplatin. Once the maximum tolerated dose of L-DOS47 as an adjunct to vinorelbine/cisplatin is determined, patients in Part 2 of the study (randomized treatment) will be randomly assigned to receive L-DOS47 in combination with vinorelbine/cisplatin or vinorelbine/cisplatin alone. Additional information about the trial can be found in the EU Clinical Trials Register (View Source).

"This is our second chemo-combination study for L-DOS47 in advanced non-small lung cancer study," said Dr. Heman Chao Ph.D., Chief Executive Officer of Helix. "We are very excited to see that L-DOS47 continues to advance in this disease indication.

On March 7, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAR 7, 2019, View Source [SID1234534082]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our accomplishments in 2018 position us for multiple potential clinical milestones in 2019 and 2020 that bring us closer to our vision of building a fully integrated company with medicines that provide a profound benefit for patients," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Building on promising clinical data for both our lead programs, we plan to expand our ongoing Phase 2 trial of SY-1425 in combination with azacitidine with the addition of a cohort in RARA and IRF8 biomarker-positive relapsed or refractory AML patients. We have also added a cohort of recurrent ovarian clear cell cancer patients to our ongoing Phase 1 trial of SY-1365. The unmet need in both these patient populations is significant, and we believe these cohorts could lead to rapid clinical proof-of-concept. These new cohorts, when combined with our ongoing evaluation of SY-1365 as a single agent in patients with high-grade serous ovarian cancer, give us three potential fast-to-market opportunities for our lead programs. We are focused on executing on our clinical trials with the aim of delivering much-needed therapies to patients as quickly as possible."

Upcoming Milestones:

SY-1425

Syros announced today that it plans to expand its ongoing Phase 2 trial to assess the safety and efficacy of SY-1425 in combination with azacitidine in RARA or IRF8 biomarker-positive patients with relapsed or refractory acute myeloid leukemia (AML). The Company expects this expansion to be open for enrollment in the third quarter.
Syros plans to complete enrollment in mid-2019 in the ongoing Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA or IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy.
Syros plans to report updated data in the second half of 2019 from the ongoing Phase 2 trial of SY-1425 in combination with azaciditine in newly diagnosed unfit AML patients.
SY-1365

Syros announced today that it has added an expansion cohort to its ongoing Phase 1 trial of SY-1365 to evaluate its safety and efficacy as a single agent in patients with recurrent ovarian clear cell cancer. The Company expects the cohort to be open for enrollment in the second quarter of 2019. This cohort will replace the cohort evaluating SY-1365 in patients with primary platinum refractory ovarian cancer.
Syros plans to report initial clinical data in the fourth quarter of 2019 from the expansion portion of its ongoing Phase 1 trial. These data are expected to include initial efficacy and safety assessments from the cohort evaluating SY-1365 as a single agent in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy; initial safety and pharmacokinetic data from the cohort evaluating SY-1365 in combination with carboplatin in high-grade serous ovarian cancer patients who have had one or more prior lines of therapy; and initial safety, efficacy and mechanistic data from the cohort evaluating SY-1365 as a single agent in patients with advanced solid tumors accessible for biopsy.
SY-5609

Syros plans to complete investigational new drug-enabling studies of SY-5609 in 2019 to support the initiation of a Phase 1 oncology trial in early 2020.
Recent Pipeline Highlights:

In December 2018, Syros’ collaborators presented new preclinical data on SY-1365 at the San Antonio Breast Cancer Symposium (SABCS). The data showed that SY-1365 inhibits tumor cell growth in hormone receptor-positive (HR-positive) breast cancer cell lines that are resistant to treatment with CDK4/6 inhibitors and that SY-1365 has synergistic activity in combination with fulvestrant in these treatment-resistant cells.
In December 2018, Syros presented initial clinical data from cohorts in its ongoing Phase 2 trial evaluating SY-1425 in combination with azacitidine at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. SY-1425 in combination with azacitidine showed high response rates and rapid onset of action in biomarker-positive patients with newly diagnosed unfit AML as of an October 29, 2018 data cut-off. The data showed:
The aggregate complete response (CR) and complete response with incomplete blood count recovery (CRi) rate was 50% in biomarker-positive patients (n=8), and the overall response rate (ORR) was 63%.
Most initial responses in biomarker-positive patients were seen at the end of the first treatment cycle, and duration of responses ranged from 29 to 337 days, with four of five responding patients remaining on treatment.
The ORR was 17% in biomarker-negative patients (n=6). While the data from this cohort were less mature due to the timing of patient enrollment, Syros believes that the difference in the observed ORR supports the potential predictive value of the RARA and IRF8 biomarkers for identifying patients most likely to respond to SY-1425.
The combination was generally well-tolerated, with no evidence of increased toxicities beyond what has been seen with either agent alone, including myelosuppression, which can occur when combining drugs to treat AML.
In December 2018, Syros also presented initial clinical data from a Phase 2 study cohort evaluating SY-1425 in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk myelodysplastic syndrome at ASH (Free ASH Whitepaper). While the data showed that SY-1425 induced CD38 expression in eight of nine evaluable patients, CD38 expression increased to levels exceeding those of a multiple myeloma cell line control in only two of these patients. Of those two, one had a morphological leukemia-free state (MLFS) response. Based on these data, Syros made a portfolio prioritization decision not to pursue further development of SY-1425 in combination with daratumumab.
In November 2018, Syros presented clinical data from the dose escalation portion of its Phase 1 trial of SY-1365 in patients with advanced solid tumors at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium (EORTC-NCI-AACR) (Free EORTC-NCI-AACR Whitepaper). The data showed proof-of-mechanism and early signs of clinical activity at tolerable doses:
Clinical activity was observed in seven of 19 response-evaluable patients, including one patient with recurrent ovarian clear cell cancer who had a confirmed partial response (PR) and six additional patients who had stable disease (SD).
Dose-dependent effects on CDK7 occupancy and downstream gene expression changes in blood cells were observed.
At doses of 32 mg/m2 and higher, CDK7 occupancy was greater than 50% when measured three days following dose administration, exceeding target occupancy levels in preclinical models that correlated with anti-tumor activity.
Adverse events were predominately low-grade, reversible and manageable.
Also at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper), Syros presented preclinical data on SY-1365 showing synergistic anti-tumor activity in combination with carboplatin in ovarian cancer cell lines and decreased expression of DNA damage response genes, providing a mechanistic rationale for the ongoing investigation of SY-1365 in combination with carboplatin in ovarian cancer patients.
Additionally, Syros presented the first preclinical data from its oral CDK7 program, detailing the selectivity, potency and anti-tumor activity of several compounds and supporting the selection of SY-5609, an oral CDK7 inhibitor, as a development candidate.
Recent Corporate Highlights:

In December 2018, Syros announced that it had been added to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective Monday, December 24, 2018.
Fourth Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of December 31, 2018 were $99.7 million, compared with $72.0 million on December 31, 2017.

For the fourth quarter of 2018, Syros reported a net loss of $18.0 million, or $0.54 per share, compared to a net loss of $15.3 million, or $0.58 per share, for the same period in 2017.

Revenues were $0.9 million for the fourth quarter of 2018, which relate entirely to Syros’ target discovery collaboration with Incyte Corporation. Syros did not record revenues in the fourth quarter of 2017.
Research and development (R&D) expenses were $15.1 million for the fourth quarter of 2018, as compared to $11.8 million for the same period in 2017. This increase was primarily attributable to an increase in SY-1365 contract manufacturing costs and professional fees in support of Syros’ clinical trials, as well as an increase in employee-related expenses.
General and administrative (G&A) expenses were $4.4 million for the fourth quarter of 2018, as compared to $3.7 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related expenses.
Full Year 2018 Financial Results

For the full year ended December 31, 2018, Syros reported a net loss of $62.3 million, or $1.91 per share, compared to a net loss of $54.0 million, or $2.13 per share, for the same period in 2017.

Revenues for the year ended December 31, 2018 were $2.1 million, as compared to $1.1 million for the same period in 2017. Revenues earned in 2018 related entirely to the Incyte collaboration. Revenues earned in 2017 were earned from a research agreement with a multinational pharmaceutical company.
R&D expenses for the year ended December 31, 2018 were $50.2 million, as compared to $41.9 million for the same period in 2017. This increase was primarily attributable to an increase in contract manufacturing costs and professional fees in support of Syros’ clinical trials, as well as an increase in employee-related expenses.
G&A expenses for the year ended December 31, 2018 were $16.2 million, as compared to $13.9 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related expenses.
Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the second quarter of 2020.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 7258556. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days.

On March 7, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) granted a fifth Breakthrough Therapy Designation (BTD) to venetoclax, for use in combination with obinutuzumab as a fixed duration investigational combination, for untreated adult patients with chronic lymphocytic leukemia (CLL) (Press release, AbbVie, MAR 7, 2019, View Source [SID1234534103]). According to the FDA, this designation is intended to expedite the review of therapies for serious or life-threatening conditions. The designation coincides with the completion of the supplemental New Drug Application (sNDA) submission to the FDA for approval in previously-untreated CLL patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FDA will review the venetoclax and obinutuzumab combination under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process to ensure safe and effective cancer medicines are available to patients as early as possible.

"We studied the venetoclax and obinutuzumab combination with a fixed treatment duration and found these medicines, used together, may enable some CLL patients to live longer without their disease getting worse, leading to longer progression-free survival, while remaining off therapy," said Mohamed Zaki, M.D., Ph.D., vice president, global head of hematology development, AbbVie. "Under the RTOR program, we are determined to work with the FDA and bring this first- and only-in-class medicine to previously-untreated CLL patients earlier than expected."

The sNDA for the venetoclax and obinutuzumab combination is based on data from the Phase 3 CLL14 trial, which studied patients receiving the combination treatment for 12 months as their first treatment for CLL. CLL14 is the first randomized trial in CLL to examine a chemotherapy-free, fixed duration treatment regimen.

The FDA’s standard review time for drug applications is six to 10 months.1 The RTOR program focuses on the early submission of data most relevant to assessing the product’s safety and effectiveness. RTOR allows the FDA to review much of the data before it is formally submitted to the FDA.

VENCLEXTA (venetoclax) is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

About Chronic Lymphocytic Leukemia
CLL is typically a slow-progressing cancer of the bone marrow and blood in which types of white blood cells called B lymphocytes become cancerous and multiply abnormally.2 In the U.S., CLL accounts for more than 20,000 newly diagnosed cases of leukemia each year.2

About the Phase 3 CLL14 Trial
The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously-untreated patients with CLL and coexisting medical conditions. The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The trial enrolled 445 patients, all of whom were previously-untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The primary endpoint was progression-free survival (PFS) based on investigator assessment, using iwCLL criteria.3

Key secondary endpoints were PFS as assessed by an independent review committee, minimal residual disease (MRD)-negativity in peripheral blood and bone marrow, overall and complete response rates, MRD-negativity in complete response in peripheral blood and bone marrow, and overall survival.

About VENCLEXTA (venetoclax tablets) (US)
VENCLEXTA is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.4

VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers.

The efficacy and safety of venetoclax in patients with previously-untreated CLL has not been evaluated by the U.S. Food and Drug Administration, the European Medicines Agency or any health authority.

In April 2016, the U.S. FDA first granted accelerated approval of VENCLEXTA for the treatment of patients with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.5 The FDA approved this indication under accelerated approval based on overall response rate.5 Based on the results of the MURANO study, VENCLEXTA was approved in June 2018 for the treatment of patients with CLL or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.4 In November 2018, VENCLEXTA was approved in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy.6

Venetoclax is approved in more than 50 countries, including the U.S. AbbVie, in collaboration with Roche, is currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

Uses and Important Safety Information (US)

Uses

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA.

It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS.
Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.
Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other, causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA.
What should I avoid while taking VENCLEXTA?
You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA. Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.
The most common side effects of VENCLEXTA when used in combination with rituximab in people with CLL include low white blood cell counts, diarrhea, upper respiratory tract infection, cough, tiredness, and nausea.

The most common side effects of VENCLEXTA when used alone in people with CLL/SLL include low white blood cell counts; diarrhea; nausea; upper respiratory tract infection; low red blood cell counts; tiredness; low platelet counts; muscle and joint pain; swelling of your arms, legs, hands, and feet; and cough.

The most common side effects of VENCLEXTA in combination with azacitidine, or decitabine, or low-dose cytarabine in people with AML include low white blood cell counts; nausea; diarrhea; low platelet counts; constipation; fever with low white blood cell counts; low red blood cell counts, infection in blood; rash; dizziness; low blood pressure; fever; swelling of your arms, legs, hands, and feet; vomiting; tiredness; shortness of breath; bleeding; infection in lung; stomach (abdominal) pain; pain in muscles or back; cough; and sore throat.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit View Source or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org for assistance.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. For more information, please visit View Source