FDA Panel Shoots Down Early Approval Request For Experimental Lung-Cancer Treatment
The advisory panel is recommending that the Food and Drug Administration wait for data from a phase 3 clinical trial before deciding on Clovis' rociletinib. In other agency news, an FDA official says long-awaited biotech medicine guidelines are still in the works.
The Wall Street Journal:
FDA Panel Opposes Approval Of Clovis Lung-Cancer Treatment
Clovis Oncology Inc. said a U.S. Food and Drug Administration advisory panel voted to recommend against early approval for the biopharmaceutical company’s experimental lung-cancer treatment. Shares fell 5.4% on Tuesday during the regular session and declined a further 3% to $13.81 in recent after-hours trading. It is the latest setback for Clovis whose lung-cancer treatment—called rociletinib—faces competition from a rival drug from AstraZeneca PLC called Tagrisso, which received U.S. regulatory approval earlier in November. (Stynes, 4/12)
FDA Still Working On Guidelines For Copycat Biotech Drugs
The director in charge of FDA’s biotechnology products office said Tuesday the agency continues to work on a long-awaited guidance to inform manufacturers of copycat biotech medicines how to prove similarity to the brand-name drug. (Williams, 4/12)