On October 3, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported duvelisib (COPIKTRATM) has received orphan drug designation from the U.S. Food and Drug Administration for use in the treatment of T-Cell lymphoma (Press release, Verastem, OCT 3, 2019, View Source [SID1234540044]). The designation was created to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases.

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"Receiving orphan drug designation for T-Cell Lymphoma, in addition to the previously-granted Fast Track status, for Peripheral T-Cell lymphoma, marks another important regulatory milestone to bring COPIKTRA to patients who are faced with this aggressive type of disease with limited therapeutic options," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "We look forward to sharing the results of our Phase 2 PRIMO study and efficiently advancing our development program in this indication."

COPIKTRA is approved in the United States for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least 2 prior therapies and accelerated approval in follicular lymphoma (FL) after at least 2 prior systemic therapies. COPIKTRA is not currently approved for the treatment of T-cell lymphoma. The Company’s ongoing Phase 2 PRIMO study will provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and further characterize its efficacy and tolerability in this population.

In the U.S., under the Orphan Drug Act, the FDA’s Office of Orphan Products Development (OOPD) grants orphan drug status to a drug or biologic intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders, which is generally a disease that affects fewer than 200,000 individuals in the U.S. and that are expected to provide a significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for benefits that apply across all stages of drug development, including an accelerated approval process, seven years of market exclusivity following marketing approval, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of certain administrative fees.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safety and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% (4% fatal) of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
INDICATIONS AND USAGE

COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with:

Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.
Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval based on overall response rate and continued approval may be contingent upon confirmatory trials
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

On October 3, 2019 Median Technologies (Paris:ALMDT) (ALMDT), The Imaging Phenomics Company, reported its results for the first half of 2019 (Press release, MEDIAN Technologies, OCT 3, 2019, View Source [SID1234540043]).

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The company’s Board of Directors met on October 1st and approved the consolidated financial statements for the first half of 2019.

With € 4 million in revenue, Median Technologies’ sales increased 19.5% compared to the first half of 2018. The company’s H1 revenue came solely from its iCRO business1.

During the first six months of 2019, Median Technologies continued to invest in the development of its imaging phenomics platform, iBiopsy and strengthened its AI and data science teams in order to cement its position as a leader in the field.

As Median started managing operations locally in China, the company’s iCRO Business Unit continued to expand, which resulted in a significant increase of Chinese orders throughout the half of the year. In Europe and the United States, new orders in the first half of 2019 exceeded the company’s expectations for the entire year. As of June 30, Median’s iCRO business unit was operationally at its break-even point.

Simplified financial statements (IFRS consolidated)

The company’s operating expenses dropped sharply compared to last year due to a 36% decrease in staff costs (€ -4.1 million as of June 30, 2019 vs. € -6.5 million as of June 30, 2018) and a 37% decrease in external costs (€ -3.5 million as of June 30, 2019 vs. € -5.6 million as of June 30, 2018).

As a result, the operating loss was cut by more than 50% to € -4.19 million. The company’s net result at the half-year mark went from € -9.0 million in 2018 to € -4.2 million in 2019.

As of June 30, 2019, Median had € 7.9 million in cash and cash equivalents, not including the Research Tax Credit payment (€1.6 million) which was received in July, and € 4.9 million in net equity. Net new orders reached € 11 million in the first half of the year bringing the company’s order backlog to € 30.7 million, up € 7 million compared to December 31, 2018. The extent of the order backlog makes Median confident about the company’s revenues for the second half of 2019 and 2020.

Latest developments and perspectives

During the third quarter of 2019, Median Technologies has continued negotiations for a € 35 million loan with the European Investment Bank (EIB), however the process was slowed down due to EIB logistical internal constrains. EIB and Median expect to finalize the agreement in Q4. Median expects the lending of the first tranche of € 15 million in the first half of 2020. Structured in three tranches, the loan will enable Median Technologies to boost investments in its imaging phenomics platform, iBiopsy, over the next few years. The ongoing negotiations for this loan were announced on May 15th.

Current trends point to the company’s positive results in the third quarter of 2019. Q3 results will be published shortly. Median’s iCRO business is expected to keep growing steadily worldwide. In the United States, two phase III contracts (totaling € 2 million) were signed in Q2, with one of the world’s top 3 pharmaceutical companies, a new customer for Median. These contracts have opened promising opportunities for Median in the US. The development of iBiopsy is progressing as planned, including an upcoming technology demonstrator at the annual convention of the RSNA (Radiological Society of North America) in early December.

"Our results for H1 have exceeded all expectations. We anticipate keeping up the momentum in the second half of the year," said Fredrik Brag, CEO and co-founder of Median.

Median informs its shareholders and the financial community at large that its financial statements for the first half of 2019 have been filed with the French market regulator and are now available on the company’s website.

On October 3, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has opened for enrollment a Phase 1b expansion cohort of its Phase 1/2 clinical trial of cirmtuzumab, a ROR1-targeted monoclonal antibody, combined with ibrutinib, in patients with mantle cell lymphoma (MCL) (Press release, Oncternal Therapeutics, OCT 3, 2019, View Source [SID1234540042]). The decision to open an expansion cohort in MCL of the ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib targeting ROR1 for Leukemia and Lymphoma) clinical trial was based on favorable interim results from the dose-finding cohort of the trial, including that the combination was well-tolerated and that complete responses were observed in two heavily pre-treated patients who had received and failed multiple chemotherapy regimens and an autologous transplant, as well as either an allotransplant or CAR-T therapy, prior to participating in this clinical trial.

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In June, the Company presented interim data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, including the preliminary results from the first six patients with MCL treated in the CIRLL clinical trial. One patient with MCL, who had relapsed following an allogeneic stem cell transplant, experienced a confirmed complete response (CR) after three months of cirmtuzumab plus ibrutinib treatment, including complete resolution of a large mediastinal mass. This CR appears to be sustained and has been confirmed to be ongoing after completing 12 months of cirmtuzumab plus ibrutinib treatment. Following ASCO (Free ASCO Whitepaper), a second confirmed CR occurred in a patient who had progressive disease after failing several different chemotherapy regimens, autologous transplant and CAR-T therapy. Additional data from this clinical trial will be presented at a future medical conference.

"It is encouraging to see that the drug has been well tolerated as well as the early signal of efficacy of cirmtuzumab with ibrutinib in MCL, particularly the rapid and durable complete responses of the heavily pre-treated patients after three months of therapy, which is an unusually fast response in this patient population," said Hun Lee, M.D., Assistant Professor of Medicine in the Department of Lymphoma & Myeloma at the University of Texas MD Anderson Cancer Center, who is an investigator on the CIRLL clinical trial.

The CIRLL clinical trial is supported by a grant from the California Institute for Regenerative Medicine (CIRM) and is being conducted in collaboration with the University of California San Diego (UC San Diego).

"We are pleased to be opening the expansion cohort portion of the CIRLL clinical trial for patients with MCL, and continue to be encouraged by the interim results from this study for both patients with MCL and patients with chronic lymphocytic leukemia, for whom a randomized Phase 2 portion of the trial was opened in August," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO.

About the CIRLL Clinical Trial

The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Part 1 of the clinical trial was a Phase 1 dose-finding portion designed to determine the Phase 2 dose, or recommended dosing regimen (RDR). Part 2 is a Phase 1b expansion cohort to confirm the RDR. Additional information about the CIRM-0001 clinical trial and other clinical trials of cirmtuzumab may be accessed at ClinicalTrials.gov.

About Cirmtuzumab

Cirmtuzumab is an investigational, potentially first-in-class monoclonal antibody targeting ROR1, or Receptor tyrosine kinase-like Orphan Receptor 1. Cirmtuzumab is currently being evaluated in a Phase 1/2 clinical trial in combination with ibrutinib for the treatment of CLL and MCL, in a collaboration with the University of California San Diego School of Medicine and the California Institute for Regenerative Medicine (CIRM). In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women with metastatic breast cancer is being conducted at the UC San Diego School of Medicine. CIRM has also provided funding to support development programs for cirmtuzumab and a CAR-T therapy that targets ROR1, which is currently in preclinical development as a potential treatment for hematologic cancers and solid tumors.

ROR1 is a potentially attractive target for cancer therapy because it is an oncofetal antigen – a protein that confers a survival and fitness advantage when reactivated and expressed by tumor cells. When expressed by hematologic malignancies such as CLL and MCL, ROR1 acts as a receptor for the tumor growth factor Wnt5a. Researchers at the UC San Diego School of Medicine discovered that targeting a critical epitope on ROR1 was key to inhibiting Wnt5a activation, specifically targeting ROR1 expressing tumors. This led to the development of cirmtuzumab that binds this critical epitope of ROR1, which is highly expressed on many different cancers but not on normal tissues. Preclinical data showed that when cirmtuzumab bound to ROR1, it blocked Wnt5a signaling, inhibited tumor cell proliferation, migration and survival, and induced differentiation of the tumor cells. Cirmtuzumab is in clinical development and has not been approved by the U.S. Food and Drug Administration for any indication.

On October 3, 2019 Biodesix, Inc., reported it has been issued U.S. Patent Number 10,422,729, which covers the Biodesix Collection Device (BCD) (Press release, Biodesix, OCT 3, 2019, View Source [SID1234540040]). The new device offers improved ease of use in blood sample collection for diagnostic testing, compared to current standard methods.

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"This device is intuitive and very easy to use," remarked Susan Garwood, M.D., Pulmonary and Advanced Bronchoscopy Lung Cancer Specialist with Centennial Medical Center in Nashville, part of the HCA TriStar division. "The Biodesix Collection Device enables the opportunity for a fast, simple collection process. Enhancing patient comfort while retaining accuracy is of top concern for all professionals drawing patient blood samples."

The BCD, currently in use with the Biodesix Nodify XL2 test, replaces the need for processing samples used for proteomic testing on-site and shipping blood tubes, which often requires cold-chain logistics during transit to the testing laboratory. This reduces the need for processing equipment such as centrifuges in the clinic, improves sample stability during transit and eliminates the need for single-use, bulky shipping containers containing materials such as Styrofoam that are not only costly but also have a negative environmental impact.

"The BCD is designed for exceptional laboratory test performance and surpasses similar collection methods by combining multiple sample processing steps, including specimen collection and reproducible sample separation with ambient shipping. Specimen stability has been demonstrated with analytic measures of proteins using highly sensitive mass spectrometry methods," said Gary Pestano, Ph.D., chief development officer at Biodesix.

"Our commitment to innovation continues to improve the customer experience," commented Scott Hutton, chief operating officer at Biodesix. "We are as focused as ever on supporting healthcare professionals and their patients by providing increasingly valuable information to physicians using a noninvasive blood collection. The new BCD significantly reduces cost and environmental impact over current sample collection practices, and we are excited to not only use this for our own tests but to make it available for broad use across the industry."

Biodesix is planning to use the new BCD in all current and future proteomic testing and also make the device available for purchase by labs and diagnostic companies wishing to use this novel technology for their own sample processing and testing. To see how the BCD is used to collect specimens for the Nodify XL2 test visit this link.

On October 3, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported a poster highlighting new preclinical duvelisib (COPIKTRA) data that will be presented at the 5th International Conference on New Concepts in Lymphoid Malignancies, which is hosted by the European School of Haematology (ESH), and is taking place October 3-5, 2019, in Estoril, Portugal (Press release, Verastem, OCT 3, 2019, View Source [SID1234540039]). The poster features preclinical research that compared duvelisib with idelalisib in preclinical models of mantle cell lymphoma (MCL). COPIKTRA is not approved for use in MCL, diffuse large B-cell lymphoma (DLBCL), or marginal zone lymphoma (MZL).

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"These data highlight MCL as a B-cell malignancy which expresses both PI3K-delta and PI3K-gamma in the malignant B cells, in addition to the role of PI3K-gamma which has already been established in cells of the supportive tumor microenvironment," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, the data show superior anti-cancer activity of the dual PI3K-delta/gamma inhibitor duvelisib compared to the PI3K-delta inhibitor idelalisib in these preclinical MCL models. At Verastem Oncology, we are working to expand into additional lymphoid malignancy indications and these data provide additional support for the future study of duvelisib through clinical trials in patients with MCL."

Duvelisib in Preclinical Models of MCL

MCL is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) that is incurable. The purpose of this research was to gain a functional understanding of the distinctive features associated with the malignant cells in MCL, with the goal of identifying potential new treatment strategies. PI3K-delta is known to be equally expressed in all B-cell malignancies and this research revealed that primary MCL cells show elevated expression of PI3K-gamma relative to primary cells from other B-cell malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). These preliminary data suggest that high levels of PI3K-gamma in MCL cells correlate with poorer disease outcomes.

The researchers then examined the effects of inhibition of specific PI3K isoforms, including PI3K-alpha, PI3K-delta (idelalisib), PI3K-gamma, and dual PI3K-delta/gamma (duvelisib), on the migration and proliferation of malignant lymphocytes from patients with MCL. These preclinical models showed that inhibition of both PI3K-delta and gamma reduced the proliferation of MCL cells whereas inhibition of PI3K-delta alone had no effect. The functional role of PI3K-delta and gamma in MCL cells was further differentiated from that of PI3K-delta alone. PI3K-delta and gamma more effectively inhibited CCL21-induced migration of MCL cell lines and primary MCL cells than did PI3K-gamma inhibition alone. Inhibition of PI3K-delta or PI3K-alpha did not affect CCL21-induced migration of MCL cells. These data suggest that when PI3K-gamma is aberrantly expressed by MCL cells, these cells become reliant on this PI3K isoform for chemokine-induced migration and tissue residency. Thus, duvelisib may have potential in MCL therapy by restricting entry, retention, and proliferation of the malignant cells within the mantle zone.

Details for the ESH 2019 poster presentation are as follows:

Title: Aberrantly Expressed PI3Kγ Contributes to Cell Proliferation and Co-Operates with PI3δ to Mediate CCL21-Induced Migration in Mantle-Cell Lymphoma: Therapeutic Implications for Duvelisib
Lead author: Kathy Till, University of Liverpool
Date and time: Thursday, October 3, 2019, beginning at 7am through the end of the conference
Location: Poster Area

A PDF copy of this poster presentation will be available here after the meeting.

SELECT IMPORTANT SAFETY INFORMATION

This does not include all information needed to use COPIKTRA (duvelisib) safely and effectively. See full Prescribing Information.

WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS

See full Prescribing Information for complete boxed warning

Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.
Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.
Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA.
WARNINGS AND PRECAUTIONS

Hepatotoxicity: Monitor hepatic function.
Neutropenia: Monitor blood counts.
Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Verastem Oncology at 1-877-7RXVSTM (1-877-779-8786).

DRUG INTERACTIONS

CYP3A inducers: Avoid co-administration with strong CYP3A inducers.
CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed.

Please see accompanying full Prescribing Information, including Boxed Warning.

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.4 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.