Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint
July 5, 2017
Bristol-Myers Squibb Company has announced that a Phase 3 study evaluating Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint at a planned interim analysis, demonstrating superior recurrence-free survival (RFS) in patients receiving Opdivo compared to Yervoy.
Merck Provides Further Update on Three Multiple Myeloma Studies Evaluating KEYTRUDA® (pembrolizumab) in Combination with Pomalidomide or Lenalidomide
July 5, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. This decision follows a review of data by the Data Monitoring Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enrollment, as announced on June 12, 2017. The FDA has determined that the data available at the present time indicate that the risks of KEYTRUDA plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.
Celgene Corporation Enters Into Global Strategic Immuno-Oncology Collaboration with BeiGene to Advance PD-1 Inhibitor Program for Solid Tumor Cancers
Jul 5, 2017
Celgene Corporation and BeiGene, Ltd. entered into a strategic collaboration to develop and commercialize BeiGene’s investigational anti-programmed cell death protein 1 (PD-1) inhibitor, BGB-A317, for patients with solid tumor cancers in the United States, Europe, Japan and rest of world outside Asia. BeiGene will retain exclusive rights for the development and commercialization of BGB-A317 for hematological malignancies globally and for solid tumors in Asia (with the exception of Japan). BeiGene will acquire Celgene’s commercial operations in China and gain an exclusive license to commercialize Celgene’s approved therapies in China – ABRAXANE®, REVLIMID® and VIDAZA®.
Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis
July 6, 2017
Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® * (ustekinumab) in psoriasis. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis- one of the most difficult-to-treat forms of psoriasis, which affects approximately 60 million people worldwide. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx.
20 July 2017
AstraZeneca and MedImmune, its global biologics research and development arm, have announced that its partner LEO Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A.
July 20, 2017
Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) receptor, specifically designed for the prevention of migraine.
Merck Announces U.S. FDA Grants Tentative Approval for LUSDUNA™ Nexvue™ (insulin glargine injection), a Follow-On Biologic Basal Insulin
July 20, 2017
Merck has announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA™ Nexvue™ (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis.
July 21, 2017
Roche has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Actemra®/RoActemra® (tocilizumab) for the treatment of giant cell arteritis (GCA), a chronic and potentially life-threatening autoimmune condition. Based on this positive CHMP recommendation, a final decision regarding the approval of Actemra / RoActemra for the treatment of GCA is expected from the European Commission in the near future. If approved, Actemra / RoActemra would be the first therapy for the treatment of GCA in Europe.
CHMP of EMA issues positive opinion for avelumab for the treatment of Metastatic Merkel Cell Carcinoma
July 21, 2017
Merck KGaA, Darmstadt, Germany and Pfizer Inc. have announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab (BAVENCIO®) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. The European Commission (EC) will now review the CHMP’s recommendation, with a decision expected in the third quarter of 2017.
Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)
July 21, 2017
Novartis has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Rydapt® (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. If approved by the European Commission (EC), Rydapt will be indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response, followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed AML who are FLT3 mutation-positive. Rydapt was also recommended for approval as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia.
CHMP recommends EU approval of Roche’s Gazyvaro for people with previously untreated advanced follicular lymphoma
July 21, 2017
Roche has announced that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro® (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment option for previously untreated advanced follicular lymphoma. The CHMP’s recommendation is based on results from the phase III GALLIUM study. Follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma, is considered incurable, and most people relapse repeatedly. Based on this positive CHMP recommendation, a final decision regarding the approval of Gazyvaro is expected from the European Commission in the near future.
European Medicines Agency’s CHMP Recommends Approval for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer
July 21, 2017
Merck has announced that the CHMP of the EMA has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, KEYTRUDA is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy.
Seattle Genetics Announces Clinical Collaboration to Expand the Therapeutic Evaluation of SGN-LIV1A in Triple Negative Breast Cancer
July 24, 2017
Seattle Genetics, Inc. has announced a clinical collaboration agreement with Genentech, a member of the Roche Group, for the evaluation of its investigational antibody-drug conjugate (ADC) SGN-LIV1A in combination with atezolizumab (TECENTRIQ®) in patients with metastatic triple-negative breast cancer (TNBC). SGN-LIV1A, one of four clinical-stage treatments under development by Seattle Genetics for solid tumors, consists of a LIV-1 targeted monoclonal antibody linked to the potent cell-killing agent monomethyl auristatin E (MMAE). Breast cancer is the most common cancer among women worldwide, with an estimated 1.7 million new cases per year.
Food and Drug Administration Expands Approval of Yervoy® (ipilimumab) to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma
July 24, 2017
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy ® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. The overall safety profile of Yervoy in children and adolescents was consistent with the safety profile in adults, and similarities in disease between adult and pediatric patients 12 years and older allow for extrapolation of data.
Lilly and Nektar Therapeutics Announce Alliance to Develop and Commercialize NKTR-358, A Novel Autoimmune Therapy
July 24, 2017
Eli Lilly and Company and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.
U.S. Food and Drug Administration Accepts Bristol-Myers Squibb’s Applications for Opdivo (nivolumab) Four-Week Dosing Schedule Across All Approved Indications
July 24, 2017
Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental Biologics License Applications (sBLAs) to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks (Q4W) for all currently approved monotherapy indications.
Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Post-ASCT Consolidation Treatment of Patients with Hodgkin Lymphoma at Increased Risk of Relapse or Progression
July 25, 2017
Seattle Genetics, Inc. has announced that Health Canada has issued a non-conditional marketing authorization for use of ADCETRIS as post-autologous stem cell transplant (ASCT) consolidation treatment of patients with Hodgkin lymphoma (HL) at increased risk of relapse or progression. The indication was based on positive results from the phase 3 AETHERA clinical trial. ADCETRIS previously received approval with conditions in Canada for two lymphoma indications: HL patients who relapse after ASCT or relapse after at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates; and for systemic anaplastic large cell lymphoma (sALCL) patients who relapse after at least one multi-agent chemotherapy regimen.
July 26, 2017
Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required. The update comes after FDA already approved the drug in the United States earlier this month.
July 27, 2017
In the preliminary MYSTIC clinical trial results, the combination of checkpoint inhibitor Imfinzi (durvalumab) and the CTLA-4 inhibitor tremelimumab failed to slow disease progression compared to chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC). This negative result raises doubts on the combination anti-PD-L1 plus CTLA-4 that is currently under investigation also by Bristol-Meyer Squibb (Opdivo + Yervoy). In a related announcement, AstraZeneca and Merck signed a deal to develop and market the PARP inhibitor Lynparza for different types of cancer.
European Commission Grants AbbVie’s MAVIRET® (glecaprevir / pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
July 28, 2017
AbbVie has announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVIRET is a new 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment, who comprise the majority of the 71 million people living with HCV globally.
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