- A committee of the European Medicines Agency (EMA) recommended the approval of BeiGene ( NASDAQ: BGNE ) Brukinsa (zanubrutinib) to treat adult patients with chronic lymphocytic leukemia (CLL).
- The positive opinion by the EMA's Committee for Medicinal Products for Human Use ( OTC:CHMP ) was backed by data from two global phase 3 trials, the company said on Friday.
- The European Commission, which generally follows the opinion of the CHMP, will now decide on the drug's approval.
- BeiGene said that tf approved, Brukinsa would be the only BTK inhibitor for CLL in the EU to achieve superior efficacy versus standard of care in head-to-head trials.
- BGNE +2.95% to $156.37 premarket Oct. 14
For further details see:
BeiGene's blood cancer drug Brukinsa gets EMA panel nod for EU approval