The new approval expands the drug's indication to include treatment in adult patients with unresectable locally advanced or metastatic triple-negative breast cancer.
Bristol Myers Squibb and bluebird bio’s Abecma is the first B-cell maturation antigen (BCMA)-directed CAR-T cell immunotherapy for relapsed or refractory multiple myeloma after 4 or more prior lines of therapy.
A data monitoring committee stopped a trial early because of evidence of "
profound efficacy," according to a press release issued by Vir Biotechnology and GlaxoSmithKline.
The FDA approved the use of Entresto in a broader group of heart failure patients that includes a large percentage of those with preserved ejection fraction.
Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.
Preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the rheumatoid arthritis and ulcerative colitis medicine Xeljanz.