The China National Drug Administration approved Merck's Keytruda for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first approval of an anti-PD-1 therapy for advanced melanoma in China.
Bristol-Myers Squibb Co. and Tsinghua University have entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers.
Genentech, a member of the Roche Group, said FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial treatment for people with advanced or metastatic hepatocellular.
Mersana Therapeutics Inc. announced that FDA has placed the phase I study of XMT-1522 on partial clinical hold.
Bristol-Myers Squibb Co. and Gritstone Oncology announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone's personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-basedvector (prime) and a self-replicating RNA-based vector (boost), in combination with Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
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.
