On March 23, 2017 Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel therapeuticsfor oncology indications of unmet medical need, reported that enrollment of Stage 3 in the SL-401 pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN) has been completed (Press release, Stemline Therapeutics, MAR 23, 2017, View Source [SID1234518259]). The company also reviewed key milestones for the SL-401 program over the coming year. Schedule your 30 min Free 1stOncology Demo! Completes Stage 3 Enrollment
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Stemline has completed enrollment of the Stage 3 cohort of the SL-401 pivotal trial in BPDCN. Stage 3 enrolled 13 first-line BPDCN patients; statistical analysis will be based on evaluable first-line patients. The registration pathway was previously agreed upon with the U.S. Food and Drug Adminstration (FDA). Depending on the data from the trial, Stemline plans to use the results generated to support the potential filing of a Biologics License Application (BLA) for full approval in first-line BPDCN, and is targeting possible BLA filing in the second half of this year.
This multicenter, pivotal trial has enrolled 47 BPDCN patients at seven centers in the U.S. The 47 BPDCN patients were comprised of 32 first-line patients (29 dosed at 12 ug/kg/day) and 15 relapsed/refractory patients dosed at 12 ug/kg/day. Stemline plans to provide a clinical update on patients enrolled in Stages 1 and 2 at a medical conference around mid-year, with top-line data from Stage 3 expected in the second half of 2017. To ensure ongoing patient access to SL-401, Stemline plans to continue to enroll both first-line and relapsed/refractory
BPDCN patients under the current protocol.
SL-401 received Breakthrough Therapy Designation (BTD) by the FDA in August 2016.
BLA Preparation and Pre-Commercial Activities Underway
Stemline’s clinical, preclinical, manufacturing, and regulatory teams are working toward a timely and comprehensive potential BLA filing. Ongoing efforts include compiling the necessary supportive data and assembling the BLA modules, including clinical, clinical pharmacology, non-clinical, and CMC (chemistry, manufacturing, and controls). In parallel, the commercial team is working to define the BPDCN market landscape, including factors related to patient flow, market access and pricing considerations, all with an eye toward setting the stage for a successful launch of SL-401, if approved.
"I am very proud of the entire Stemline team and our clinical investigators, who helped to make this key milestone possible," said Ivan Bergstein, M.D., Chief Executive Officer of Stemline. Dr. Bergstein, continued "Completing enrollment in our pivotal trial is an important step toward our goal of bringing to market a novel treatment for patients suffering from BPDCN, a devastating disease. We continue to focus on following patients, data collection, and advancing our BLA-targeted efforts on all fronts."
Author: [email protected]
ANNOUNCES TARGET AND OUTLINES DESIGN FOR ITS FIRST CLINICAL TRIAL IN TCR CANCER IMMUNOTHERAPY
On March 23, 2017 Medigene AG (FSE: MDG1, Prime Standard, TecDAX), reported details on the Company’s first clinical trial with T-cell receptor-modified T cells, planned to start in late 2017 (Press release, MediGene, MAR 23, 2017, View Source [SID1234518258]). Medigene will use an HLA-A2:01-restricted T-cell receptor (TCR) that targets PRAME, a well characterized tumor antigen. Medigene identified a TCR candidate for this target that demonstrates favorable safety and efficacy in extensive preclinical studies. Data on Medigene’s selected TCR candidate will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 1-5, in Washington, D.C., USA.
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Subject to regulatory approval, Medigene intends to start a combined Phase I/II safety and feasibility trial of its TCR targeting PRAME, named MDG1011, in patients with advanced hematological diseases, namely acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and multiple myeloma (MM). The Phase I part of this First-in-Man trial is designed as a dose escalation, testing up to 4 dose cohorts in a 3+3 design. The chosen dose will then be further tested in the Phase II part which will include a prospective control group and might potentially be extended into further malignancies. Final details, including trial size, study sites and timelines will become available after clinical trial approval by the competent authority.
Prof. Dolores Schendel, CEO and CSO of Medigene, commented: "Based on extensive preclinical assessment, we are convinced that our TCR specific for the PRAME antigen with high avidity, potent antitumor efficacy and a favorable safety profile will enable us to execute a unique clinical program. This particular trial design examining various indications in parallel allows for faster decisions about future clinical development options based on multiple clinical data sets."
The antigen PRAME (Preferentially Expressed Antigen in Melanoma) was first discovered in melanoma and is overexpressed in a variety of solid cancer indications and several hematological malignancies, while its expression pattern in normal tissue is mainly limited to testis, making it an attractive target for adoptive T cell therapy. As this antigen is expressed intracellularly, it is an ideal candidate for a TCR approach, which otherwise could not be targeted with chimeric antigen receptor (CAR) T cells. Medigene already uses PRAME as a target in its ongoing DC-vaccine trial in AML, where the favorable safety profile of this vaccine allowed the trial to advance into Phase II in April 2016 (Phase I/II final data expected for late 2019).
To view the abstract of the upcoming AACR (Free AACR Whitepaper) presentation please visit: bit.ly/2nnExnY
About Medigene’s TCR technology: The TCR technology aims at arming the patient’s own T cells with tumor-specific T-cell receptors. The receptor-modified T cells are then able to detect and efficiently kill tumor cells. This immunotherapy approach attempts to overcome the patient’s tolerance towards cancer cells and tumor-induced immunosuppression by activating and modifying the patient’s T cells outside the body (ex vivo).
TCR therapy is developed to utilize a higher number of potential tumor antigens than other T cell-based immunotherapies, such as chimeric antigen receptor T cell (CAR T) therapy. Medigene is preparing the clinical development of its first TCR candidates and is establishing a pipeline of recombinant T-cell receptors, and has established Good Manufacturing Practice (GMP)-compliant processes for their combination with patient-derived T cells.
Medigene’s TCR technology for adoptive T-cell therapy is one of the company’s three highly innovative and complementary immunotherapy platforms in immuno-oncology.
C4 THERAPEUTICS AND CALICO ENTER STRATEGIC PARTNERSHIP TO DISCOVER NOVEL THERAPEUTICS BASED ON TARGETED PROTEIN DEGRADATION
On Mach 23, 2017 C4 Therapeutics (C4T) and Calico reported a five-year collaboration to discover, develop and commercialize therapies for treating diseases of aging, including cancer (Press release, C4 Therapeutics, MAR 23, 2017, View Source [SID1234518257]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, the parties will leverage C4T’s expertise and capabilities in targeted protein degradation to jointly discover and advance small molecule protein degraders as therapeutic agents to remove certain disease-causing proteins. The partnership will pursue preclinical research and Calico will be responsible for subsequent clinical development and commercialization of resulting products that may emerge from the collaboration.
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"We are thrilled to have Calico as partners in pioneering novel therapeutics based on targeted protein degradation," said Andrew Phillips, President and Chief Scientific Officer of C4 Therapeutics. "Calico’s leadership team has a long record of innovation and our combined efforts are aimed at bringing forward new options for patients affected by devastating diseases such as cancer."
"We know from decades of translational research that it can be incredibly challenging to find effective pharmacologic inhibitors of many of the biologically well-validated targets, particularly in cancer," said Hal Barron, President of Research and Development at Calico. "Through the alternative strategy of specifically targeting such proteins for degradation, we believe we have the opportunity to identify promising new therapeutics in cancer and in other diseases as well. We’re looking forward to collaborating with C4T’s scientists and applying their protein degradation technology to the discovery and development of effective new treatments."
Ignyta Announces Exploration of Strategic Options for Taladegib, Enabled by Amendment of Taladegib License Agreement with Lilly
On March 23, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported that it is exploring strategic options for taladegib and has entered into an amended and restated license, development and commercialization agreement with Eli Lilly and Company for the taladegib oncology program (Press release, Ignyta, MAR 23, 2017, View Source [SID1234518256]). Ignyta had previously disclosed it was in discussions with Lilly regarding the optimal path forward for taladegib in the context of its pipeline priorities, which are focused substantially on molecularly targeted therapies, including its lead product candidate, entrectinib. Schedule your 30 min Free 1stOncology Demo! The agreement amends and restates the prior license, development and commercialization agreement, dated November 6, 2015, by and between Ignyta and Lilly. Taladegib is a potent, orally bioavailable small molecule hedgehog/smoothened antagonist that has achieved clinical proof-of-concept and a recommended Phase 2 dose based on results from prior clinical studies.
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"Ignyta is excited to continue to develop potential combinations of taladegib with other products to address residual disease, while exploring strategic options for single agent taladegib oral and the topical formulation of taladegib by sub-licensing or selling the franchise to dermatology-focused companies who may have an interest in superficial, nodular, and advanced basal cell carcinoma (BCC). We have received inbound interest on these assets in these BCC indications, and will be weighing the merits of these potential partnerships with other opportunities to develop taladegib internally for the benefit of patients with rare cancers outside of BCC. We are pleased to have achieved an amicable resolution with Lilly to provide Ignyta with a clear path forward for pursuing these various strategic options for taladegib," said Jonathan Lim, M.D., Chairman and CEO of Ignyta.
FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma
On March 23, 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 approved BAVENCIO (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) (Press release, Pfizer, MAR 23, 2017, View Source [SID1234518255]). This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.1 BAVENCIO was developed, reviewed and approved through the FDA’s Breakthrough Therapy Designation and Priority Review programs. Schedule your 30 min Free 1stOncology Demo! BAVENCIO, a human anti-PD-L1 antibody, is the first FDA-approved therapy for patients with mMCC.2 Metastatic MCC is a rare and aggressive skin cancer, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years.3
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"At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers like metastatic Merkel cell carcinoma," said Belén Garijo, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany. "BAVENCIO’s journey has included years of hard work – from the scientists who discovered this molecule in our labs, to our alliance with Pfizer and to the study participants and investigators worldwide. We are grateful to all who have made it possible for us to bring this important new treatment option to patients."
"Today is a significant milestone for people fighting metastatic Merkel cell carcinoma, who until now have not had any options beyond chemotherapy," said Albert Bourla, Group President, Pfizer Innovative Health. "This approval demonstrates the power of collaboration to accelerate meaningful new choices for cancer patients."
"Merkel cell carcinoma is rarer than some of the more well-known skin cancers, however, it’s very aggressive and the proportion of people who die from MCC is much higher than that of people with melanoma," said Deborah S. Sarnoff, MD, President of the Skin Cancer Foundation. "With this approval, I believe there is new hope for people and their families touched by this rare form of skin cancer."
The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center study conducted in 88 patients with histologically confirmed metastatic MCC whose disease had progressed on or after chemotherapy administered for distant metastatic disease. Sixty-five percent of patients were reported to have had one prior anti-cancer therapy for metastatic MCC and 35% had two or more prior therapies. The major efficacy outcome measures were confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by a blinded independent central review committee (IRC) and IRC-assessed duration of response.
The overall response rate (ORR) was 33% (95% confidence interval [CI]: 23.3–43.8%).1 Eleven percent of patients experienced a complete response (95% CI: 6.6-19.9%) and 22% of patients experienced a partial response (95% CI: 13.5-31.7%). Tumor responses were durable, with 86% of responses lasting for at least six months (n=25).1 Forty-five percent of responses lasted at least 12 months (n=13).1 Duration of response ranged from 2.8 to over 23.3 months.
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) included fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reactions (22%), rash (22%), decreased appetite (20%) and peripheral edema (20%).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 been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.1
BAVENCIO is available for order now.
The alliance is committed to providing industry-leading patient access and reimbursement support through its CoverOne program. 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. CoverOne may be reached by phone at 844-8COVER1 (844-826-8371) or online at www.CoverOne.com (link is external).
About JAVELIN Merkel 200
The efficacy and safety of BAVENCIO was demonstrated in the JAVELIN Merkel 200 trial, an open-label, single-arm, multi-center study conducted in 88 patients with histologically confirmed metastatic MCC whose disease had progressed on or after chemotherapy administered for distant metastatic disease. Sixty-five percent of patients were reported to have had one prior anti-cancer therapy for metastatic MCC and 35% had two or more prior therapies. The major efficacy outcome measures were confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by a blinded independent central review committee (IRC) and IRC-assessed duration of response.
The trial excluded patients with autoimmune disease; medical conditions requiring systemic immunosuppression; prior organ or allogenic stem cell transplantation; prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibodies; CNS metastases; infection with HIV, hepatitis B or hepatitis C; or ECOG performance score greater than or equal to two. Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.
The international clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs, including nine Phase III trials, and more than 4,000 patients across more than 15 tumor types. In October 2016, the alliance announced the European Medicines Agency accepted the Marketing Authorisation Application for avelumab for the proposed indication of metastatic MCC.
For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com (link is external) or the FDA website (link is external).
IMPORTANT SAFETY INFORMATION and INDICATION
BAVENCIO can cause immune-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 cause immune-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 cause immune-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 cause immune-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 or greater) 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 cause immune-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 cause severe (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 cause fetal 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 one 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 one 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, greater than or equal to 20%) in patients with metastatic MCC were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reactions (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%). The most common adverse reaction requiring dose interruption was anemia.
Selected treatment-emergent laboratory abnormalities (all grades, greater than or equal to 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%). and increased alanine aminotransferase (20%). Selected treatment-emergent Grade 3-4 laboratory abnormalities (greater than or equal to 2%) were lymphopenia (19%), anemia (9%), hyperglycemia (7%), increased alanine aminotransferase (5%), and increased lipase (4%).
INDICATION
BAVENCIO is indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Please see full Prescribing Information (link is external) and Medication Guide (link is external).
AboutBAVENCIO (avelumab)
BAVENCIO is a human programmed death ligand-1 (PD-L1) blocking antibody indicated in the US for the treatment of adults and pediatric patients 12 years of age and older with metastatic Merkel cell carcinoma.1 This indication is approved under accelerated approval based on tumor response and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
BAVENCIO is not approved in any market outside the US.