FDA approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
FDA granted an accelerated approval to Keytruda (pembrolizumab) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
FDA extended the action date for the supplemental Biologics License Application for Keytruda (pembrolizumab) for previously treated patients with advanced microsatellite instability-high cancer.
Mylan N.V. announced that the company has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product.
Oncoceutics Inc. announced research collaborations with various groups within the NIH to study DRD2 as a novel therapeutic target in oncology.
The National Institute for Health and Care Excellence issued a Final Appraisal Determination recommending panitumumab as an option for patients with previously untreated, RAS wild-type metastatic colorectal cancer in adults in combination with the FOLFOX or FOLFIRI chemotherapy regimens.
EnGeneIC Ltd., a clinical stage biopharmaceutical company focused on developing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, said FDA has granted Orphan Drug Designation to EGFR-targeted, doxorubicin-loaded EDV nanocells for the treatment of glioblastoma multiforme.
Agendia Inc. said its MammaPrint 70-Gene Breast Cancer Risk-of-Recurrence test is now included with the highest medical evidence level 1A in the latest version of AGO (German Association of Gynecological Oncology) guidelines for the care of breast cancer patients in Germany.
Lexicon Pharmaceuticals Inc. said FDA approved Xermelo (telotristat ethyl) 250 mg as a first and only orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog therapy in adults inadequately controlled by SSA therapyi.
Merck and Pfizer Inc. said FDA accepted for priority review the BLAfor avelumab for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy.