Bristol-Myers Squibb Co. said FDA accepted its supplemental Biologics License Applications to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications.
AstraZeneca and Merck & Co. Inc. entered a global collaboration to co-develop and co-commercialize AstraZeneca's Lynparza (olaparib) for multiple cancer types.
Novartis said the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Rydapt (midostaurin) for the treatment of adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive.
FDA approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
Bristol-Myers Squibb Co. said the FDA accepted its supplemental New Drug Application to include an indication for Sprycel (dasatinib) to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia, as well as a powder for oral suspension formulation of Sprycel.
FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) to include overall survival data from the phase III TOWER study.
Merck said 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.
FDA cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy.
FDA granted marketing approval June 29 to the Praxis Extended RAS Panel, a next generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the identification of patients who may be eligible for treatment with panitumumab (Vectibix, Amgen, Inc.).
FDA approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.
