Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, announced a new clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca's durvalumab, a human monoclonal antibody directed against programmed death-ligand 1, in combination with SNDX-6352, Syndax's monoclonal antibody inhibitor of Colony-StimulatingFactor 1 Receptor, across a variety of solid tumors.
Foundation Medicine Inc. said the company has entered into a broad partnership with Pfizer Inc.
FDA has approved the supplemental New Drug Application to add overall survival data from the phase III head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis (carfilzomib).
Novartis said its supplemental Biologics License Application for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by FDA for Priority Review.
FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of metastatic breast cancer whose tumors have a specific germline mutation.
FDA has approved Genentech's Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
FDA approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma.
FDA approved a supplemental New Drug Application to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphiachromosome-positive chronic myelogenous leukemia.
Amgen said FDA has approved the supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Kisqali (ribociclib) received FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
