BioCentury
ARTICLE | Company News

CHMP backs Tagrisso, Portrazza, Zurampic

December 19, 2015 2:48 AM UTC

EMA's CHMP issued opinions backing marketing authorization of non-small cell lung cancer (NSCLC) therapies Tagrisso osimertinib from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Portrazza necitumumab from Eli Lilly and Co. (NYSE:LLY), as well as AZ's gout treatment Zurampic lesinurad.

CHMP recommended Tagrisso to treat locally advanced or metastatic EGFR T790M mutation-positive NSCLC. Last month, FDA granted accelerated approval to the oral irreversible inhibitor of EGFR-activating mutations and the T790M EGFR resistance mutation. FDA's indication specifies that patients have progressed after EGFR-blocking therapy (see BioCentury Extra, Nov. 13). ...