Takeda's Ninlaro gets conditional approval in EU

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said the European Commission conditionally approved Ninlaro ixazomib in combination with Revlimid lenalidomide and dexamethasone to treat adults with multiple myeloma who received at least one prior therapy. FDA has approved the combination for the same indication.

In September, EMA’s CHMP reversed an earlier opinion and recommended conditional approval of the Ninlaro combination following an appeal by Takeda. In its reversal, CHMP concluded that Ninlaro's benefits outweigh its risks, citing expert opinions, progression-free survival (PFS) data and a favorable safety profile (see BioCentury Extra, Sept. 16)...