BioCentury
ARTICLE | Clinical News

Amgen's Blincyto among negative CHMP opinions

August 3, 2018 5:47 PM UTC

EMA's CHMP released a handful of negative opinions July 27, including one for Blincyto blinatumomab from Amgen Inc. (NASDAQ:AMGN) and, on re-examination, negative recommendations for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC from Radius Health Inc. (NASDAQ:RDUS). As expected, the committee also issued a negative opinion for Opdivo nivolumab plus Yervoy ipilimumab from Bristol-Myers Squibb Co. (NYSE:BMY) in first-line renal cell carcinoma.

CHMP did not recommend expanding Blincyto's label to include treatment of B cell precursor acute lymphoblastic leukemia (ALL) in patients who are in remission but still have minimal residual disease (MRD). In March, the bispecific T cell engager (BiTE) against CD19 became the first drug FDA approved to treat the condition. Blincyto is approved in the EU to treat Philadelphia chromosome-negative (Ph-) relapsed or refractory B cell precursor ALL...