On May 9, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for first-quarter 2017 and provided an update on the Company’s commercial products and development programs (Press release, TESARO, MAY 9, 2017, View Source [SID1234519083]).

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"The recent FDA approval and U.S. launch of ZEJULA represents a significant advancement for patients with recurrent ovarian cancer and marked a key milestone for the Company," said Lonnie Moulder, CEO of TESARO. "TESARO is committed to supporting people bravely facing cancer, and we are very gratified by the early positive feedback we have received from physicians and patients as they begin to utilize ZEJULA. The unprecedented results of the NOVA trial support our view of ZEJULA as the foundation of a broad franchise opportunity with potential applications across a variety of tumor types, as both a monotherapy and in combination, and we will be advancing multiple new clinical trials of niraparib in metastatic ovarian, breast and lung cancers. Following the recent approval of VARUBY by the European Commission, we are preparing to globalize our mission and bring this important product to patients in Europe beginning in June. Our immuno-oncology programs continue to rapidly advance, and we look forward to reporting initial data from our trials this year."

Recent Business Highlights

The U.S. launch of ZEJULA is off to a strong start, with approximately 500 prescriptions written since approval. TESARO launched ZEJULA in late April, following U.S. Food and Drug Administration (FDA) approval for use as a maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require patient selection with a biomarker test.
The National Comprehensive Cancer Network (NCCN) recently added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology Ovarian Cancer version 1.2017—April 12, 2017—as maintenance therapy for patients with platinum-sensitive disease who are in partial or complete response after completion of two or more lines of platinum-based therapy.
A substantial expansion of the niraparib clinical development program is underway to include multiple Phase 2 and Phase 3 combination trials of niraparib plus an anti-PD-1 antibody or AVASTIN (bevacizumab) in patients with ovarian cancer, non-small cell lung cancer (NSCLC), advanced squamous non-small cell lung cancer, and triple negative breast cancer.
Enrollment continues in the Phase 3 PRIMA trial of niraparib for patients with first-line ovarian cancer, the TOPACIO trial of niraparib plus KEYTRUDA in patients with platinum-resistant ovarian cancer or with triple negative breast cancer, and in the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy.
Secondary endpoint results presented in March at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer from the Phase 3 ENGOT-OV16/NOVA trial demonstrated the positive and durable treatment effect of niraparib in a broad population of patients with ovarian cancer, regardless of germline BRCA mutation status.
VARUBY (oral formulation) was approved by the European Commission for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults, and commercial launches in Europe are planned to begin in June on a country-by-country basis.
The VARUBI IV NDA was resubmitted to the FDA to enable potential approval during the second quarter.
Following identification of a fixed dose and patient-centric administration schedule for the anti-PD-1 antibody, TSR-042, a registrational development program is open to enroll patients with metastatic MSI-H endometrial cancer. This study is designed to support a request for accelerated approval and Biologics License Application (BLA) submission to the FDA.
Enrollment continues in the dose escalation phase of a study of TESARO’s anti-TIM-3 antibody, TSR-022, and a study of TSR-022 plus TSR-042, TESARO’s anti-PD-1 antibody, will initiate by mid-year.
An Investigational New Drug (IND) application for TSR-033, an anti-LAG-3 antibody, was submitted to the FDA, with a Phase 1 trial planned to begin in mid-2017.
First Quarter 2017 Financial Results

TESARO reported net product revenue of $2.1 million for the first quarter of 2017, compared to $0.3 million for the first quarter of 2016, consisting of sales of VARUBI to our specialty pharmacy and specialty distributor customers.

Research and development expenses increased to $66.1 million for the first quarter of 2017, compared to $52.7 million for the first quarter of 2016, driven primarily by higher costs related to the ongoing trials of niraparib, TSR-042 and TSR-022, advancement of our earlier-stage immuno-oncology portfolio, and increased headcount.

Selling, general and administrative expenses increased to $69.3 million for the first quarter of 2017, compared to $30.1 million for the first quarter of 2016, primarily due to activities in support of the launches of VARUBI/VARUBY and ZEJULA in the U.S. and Europe, increased headcount, and higher professional service fees.

Operating expenses as described above include total non-cash, stock-based compensation expense of $18.4 million for the first quarter of 2017, compared to $9.5 million for the first quarter of 2016.

Net loss totaled $136.7 million, or ($2.55) per share, for the first quarter of 2017, compared to a net loss of $91.0 million, or ($2.22) per share, for the first quarter of 2016.

In line with the Company’s previous guidance, TESARO’s cash and cash equivalents balance declined by approximately $114 million during the first quarter. As of March 31, 2017, TESARO had approximately $672 million in cash and cash equivalents and approximately 53.8 million outstanding shares of common stock.

Corporate Objectives

TESARO anticipates achieving the following key objectives:

VARUBI / VARUBY (rolapitant):

Launch VARUBI IV into the U.S. market in mid-2017, pending FDA approval; and
Launch VARUBY oral in Europe on a country-by-country basis beginning in June.
ZEJULA (niraparib):

Continue to execute on the ongoing U.S. launch of ZEJULA and on pre-launch preparations in support of a European launch by year-end 2017, pending European Commission approval;
Report initial data from the TOPACIO trial in patients with platinum-resistant, recurrent ovarian cancer at TESARO’s ASCO (Free ASCO Whitepaper) investor event;
Report QUADRA data in 2H 2017;
Continue to enroll the Phase 3 PRIMA trial throughout 2017;
Begin to initiate expanded ovarian, breast and lung cancer development program in 2017; and
Update AVANOVA data in 2H 2017.
Immuno-Oncology Portfolio:

Enroll patients with MSI-H metastatic endometrial cancer in the ongoing trial of TSR-042, with the intent of submitting the results and a request to FDA for accelerated approval;
Identify the first clinical candidate within the MD Anderson collaboration in Q2 2017;
Identify a dose and schedule for TSR-022 by mid-2017 and for TSR-022 plus an anti-PD-1 mAb in 2H 2017;
Initiate a Phase 1 trial of TSR-033 in mid-2017; and
Initiate pre-IND-enabling studies for a bi-specific antibody lead clinical candidate targeting PD-1/LAG-3 in 2H 2017.

ZEJULA (niraparib) Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in all clinical studies. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.

In clinical studies, the most common adverse reactions included: thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, abdominal pain/distension, mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash and hypertension.

Please see full Prescribing Information for additional Safety Information at www.zejula.com.

On May 9, 2017 Sierra Oncology, Inc. (NASDAQ: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, today reported its financial and operational results for the first quarter ended March 31, 2017 (Press release, Sierra Oncology, MAY 9, 2017, View Source [SID1234519049]).

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"During the quarter, we continued to advance our lead DDR-targeting drug candidate, SRA737, in two ongoing Phase 1 clinical trials, while concurrently proposing design amendments to these studies that we believe could augment their potential for success," said Dr. Nick Glover, President and CEO of Sierra Oncology. "As we prepare to implement these enhancements, we also remain focused on driving patient enrollment with the objective of providing an initial update from these trials in early 2018."

During the first quarter, Sierra successfully transferred sponsorship of the two ongoing Phase 1 clinical trials for its checkpoint kinase 1 (Chk1) inhibitor, SRA737, to the company. This transfer positioned Sierra to submit protocol amendments seeking to incorporate the prospective enrollment of patients with genetically-defined tumors, determined using Next-Generation Sequencing, that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

First Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.0 million for the first quarter of 2017, compared to $6.6 million for the first quarter of 2016. The increase was primarily due to an increase in third-party manufacturing and research costs related to SRA737 and SRA141. These costs were partially offset by a decrease in clinical trial and personnel-related costs due to the discontinuation of PNT2258. Research and development expenses included non-cash stock based compensation of $1.0 million for both the first quarter of 2017 and of 2016.

General and administrative expenses were $3.1 million for the first quarter of 2017, compared to $4.0 million for the first quarter of 2016. This decrease was primarily due to a decrease in professional fees, business development expenses and personnel-related costs. General and administrative expenses included non-cash stock based compensation of $0.5 million for the first quarter 2017, compared to $0.4 million for the first quarter 2016.
Net loss was $11.1 million for the first quarter of 2017, compared with a net loss of $10.5 million for the first quarter of 2016.

Cash and cash equivalents totaled $125.0 million as of March 31, 2017, compared to $109.0 million as of December 31, 2016. This increase was due to an underwritten public offering of 21,847,636 shares of common stock in February 2017, pursuant to which the company raised net proceeds of $27.4 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019. At March 31, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,615,052 shares of common stock issued and outstanding.

On May 9, 2017 Merck and Pfizer Inc. (NYSE: PFE) reported that the US Food and Drug Administration (FDA) has approved BAVENCIO (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy FDA Grants Bavencio (avelumab) Approval for a Common Type of Advanced Bladder Cancer (Press release, Merck KGaA, MAY 9, 2017, View Source;newsType=1 [SID1234518979]). BAVENCIO was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.1 BAVENCIO will be co-commercialized by EMD Serono, the biopharmaceutical business of Merck in the US and Canada, and Pfizer.

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"This approval for BAVENCIO in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. "Coming just a few weeks after the approval for metastatic Merkel cell carcinoma, we continue to demonstrate our ability to accelerate access to innovative medicines for patients in need."
"This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers," said Liz Barrett, Global President, Pfizer Oncology. "By drawing on the strength of the alliance, as well as Pfizer’s deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients."

Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the US.2,3 When the disease has metastasized, the five-year survival rate is approximately 5%.4 Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.2

"Once urothelial carcinoma progresses after treatment with chemotherapy, the five-year survival rate is alarmingly low," said Dr. Andrea Apolo, National Cancer Institute, Bethesda, MD, US. "Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease."

The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts (N=242) of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study of BAVENCIO in the treatment of various solid tumors. The urothelial carcinoma cohorts enrolled patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen. These data will be presented at an upcoming medical congress.

The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity. The most common adverse reactions (reported in at least 20% of patients) in patients with locally advanced or metastatic urothelial carcinoma were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).1 For more information, please see Important Safety Information for BAVENCIO below.

BAVENCIO is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, BAVENCIO is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T cells, exposing them to anti-tumor responses.1 BAVENCIO has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.1

The alliance is committed to providing industry-leading patient access and reimbursement support through its CoverOne program in the United States. This program provides a spectrum of patient access and reimbursement support services intended to help patients receive appropriate access to BAVENCIO in the United States.

About Urothelial Carcinoma Cohorts in JAVELIN Solid Tumor Trial
The efficacy and safety of BAVENCIO was demonstrated in the urothelial carcinoma cohorts of the JAVELIN Solid Tumor trial, a Phase I, open-label, single-arm, multicenter study that included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen who were treated with BAVENCIO.

Patients with active or a history of central nervous system metastasis; other malignancies within the last five years; an organ transplant; conditions requiring therapeutic immune suppression; or active infection with HIV, hepatitis B or C were excluded. Patients with autoimmune disease, other than type 1 diabetes, vitiligo, psoriasis, or thyroid disease that did not require immunosuppressive treatment, were excluded. Patients were included regardless of their PD-L1 status. Patients received BAVENCIO at a dose of 10 mg/kg intravenously over 60 minutes every two weeks until disease progression or unacceptable toxicity. Tumor response assessments were performed every six weeks, as assessed by an Independent Endpoint Review Committee (IERC) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Efficacy outcome measures included confirmed overall response rate (ORR) and duration of response (DOR). Efficacy measures were evaluated in patients who were followed for a minimum of both 13 weeks and 6 months at the time of data cut-off.

Out of the total 226 patients evaluable for efficacy, 44% had non-bladder urothelial carcinoma, including 23% of patients with upper tract disease; 83% of patients had visceral metastases; 34% of patients had liver metastases. Nine patients (4%) had disease progression following prior platinum-containing neoadjuvant or adjuvant therapy only. Forty-seven percent of patients only received prior cisplatin-based regimens, 32% received only prior carboplatin-based regimens, and 20% received both cisplatin and carboplatin-based regimens.

The international clinical development program for avelumab, known as JAVELIN, involves more than 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types.

In December 2015, Merck and Pfizer announced the initiation of a Phase III multicenter, multinational, randomized, open-label, parallel-arm study (JAVELIN Bladder 100) of BAVENCIO plus best supportive care versus best supportive care alone as a maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma whose disease did not progress after completion of first-line platinum-containing chemotherapy. This trial is currently enrolling patients.

IMPORTANT SAFETY INFORMATION and INDICATIONS
BAVENCIO can causeimmune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can causeimmune-mediated hepatitis, including fatal cases.Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5 and 11 (0.6%) with Grade 3.

BAVENCIO can causeimmune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis and permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3.

BAVENCIO can causeimmune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life- threatening (Grade 4) thyroid disorders. Thyroid disorders including hypothyroidism, hyperthyroidism, and thyroiditis were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade ≥ 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can causeimmune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment.Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation.For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.

BAVENCIO can causesevere (Grade 3) or life-threatening (Grade 4)infusion-related reactions.Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO can causefetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial cancer (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%) and urinary tract infection (21%).

Selected laboratory abnormalities (grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), gamma-glutamyltransferase increased (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

INDICATIONS
BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).

BAVENCIO is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab has not yet been approved for any indication in any market outside of the US. As announced on October 31, 2016, the European Medicines Agency (EMA) has validated for review Merck’s Marketing Authorization Application for avelumab, for the proposed indication of metastatic Merkel cell carcinoma.

About BAVENCIO(avelumab)
BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, as well as for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.1 These indications are approved under accelerated approval based on tumor response and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO is not approved for any indication in any market outside the US.

On May 9, 2017 EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) reported that the US Food and Drug Administration (FDA) has granted accelerated approval for BAVENCIO (avelumab) Injection for a second indication (Press release, Pfizer, MAY 9, 2017, View Source [SID1234518955]). The full prescribing information for BAVENCIO will be available at www.BAVENCIO.com.

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The full prescribing information for BAVENCIO will be available at www.BAVENCIO.com.

EMD Serono and Pfizer will provide additional details on the approval in a press release to follow.

(Press release, Jazz Pharmaceuticals, MAY 9, 2017, View Source;p=irol-SECText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTExNTgzMDQ5JkRTRVE9MCZTRVE9MCZTUURFU0M9U0VDVElPTl9FTlRJUkUmc3Vic2lkPTU3 [SID1234518948])

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