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.
The gains in insurance coverage with the Patient Protection and Affordable Care Act have translated into improved health for young women with gynecologic cancers, who are getting diagnosed at earlier stages of their disease because of ACA benefits, a study by Johns Hopkins Medicine found.
Takeda Pharmaceutical Co. Ltd. announced the randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral Ninlaro (ixazomib) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival versus placebo.
A study by researchers from the International Agency for Research on Cancer, published in JAMA Oncology, demonstrates that a blood test measuring four protein biomarkers can improve the identification of individuals who would later develop lung cancer.
Pediatric surgeon J. Ted Gerstle was named chief of the Pediatric Surgery Service in the Department of Surgery at Memorial Sloan Kettering Cancer Center.
Richard Pestell will join CytoDyn Inc. of Vancouver as chief medical officer.
Rob Beck was named Chief Operating Officer of the Leukemia & Lymphoma Society.
