FDA approved Amgen and Allergan Kanjinti's (trastuzumab-anns) for all approved indications of the reference product, Herceptin (trastuzumab) for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
The European Commission has approved Lynparza as monotherapy for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
Japan's Pharmaceuticals and Medical Devices Agency has approved Lynparza as a maintenance treatment after first-line chemotherapy in patients with BRCA-mutated ovarian cancer.
Myriad Genetic Laboratories Inc. said the Japanese Ministry of Health, Labour, and Welfare has granted a second manufacturing and marketing approval for Myriad's BRACAnalysis Diagnostic System as a companion diagnostic with the PARP inhibitor, Lynparza (olaparib).
Gilead Sciences Inc. and Nurix Therapeutics Inc. formed a collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.
FDA granted accelerated approval to Polivy (polatuzumab vedotin-piiq), a novel antibody-drug conjugate, in combination with the chemotherapy bendamustine and rituximab product, to treat adult patients with diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies.
FDA has approved Merck's Keytruda as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score ≥1) or in combination with platinum and fluorouracil for the first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
FDA has approved Agilent Technologies Inc.'s PD-L1 IHC 22C3 pharmDx assay for expanded use.
Cofactor Genomics said it has become a member of the Foundation for NIH Biomarkers Consortium with the goal of advancing the adoption of multidimensional biomarkers in cancer and immune-related diseases.
Genmab A/S announced FDA granted a Priority Review for the supplemental Biologics License Application for the use of daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant.
