FDA has granted accelerated approval to Yervoy (ipilimumab) for use in combination with Opdivo (nivolumab) for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Astellas Pharma and Pfizer said FDA has approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation, based on results from the phase III PROSPER trial.
Merck said FDA has accepted and granted priority review for a new supplemental Biologics License Application seeking approval for Keytruda, an anti-PD-1 therapy, as a treatment for previously treated patients with advanced hepatocellular carcinoma.
Genentech has submitted an sNDA to the FDA for Venclexta (venetoclax), in combination with a hypomethylatin agent or in combination with low dose cytarabine, for treatment of people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy.
FDA has limited the use of Tecentriq and Keytruda for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.
Novartis announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Kymriah (tisagenlecleucel, formerly CTL019)—a one-time treatment that uses a patient's own T cells to fight cancer.
FDA has accepted for review a supplemental Biologics License Application for Keytruda, Merck's anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.
AstraZeneca and Merck announced Japan's Pharmaceuticals and Medical Devices Agency has approved Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated, human epidermal growth factor receptor 2-negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic.
FDA has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
Kymab Group Ltd. announced a clinical trial agreement with F. Hoffmann-La Roche Ltd.
