Biosimilars For Avastin, Herceptin To Cap Off Busy July For ODAC
Pfizer's Mylotarg attempt to return to US market is first up for FDA's Oncologic Drugs Advisory Committee, followed by Novartis's CAR-T therapy. ODAC will then give half-day review to Amgen's and Mylan's biosimilars, suggesting FDA is increasingly comfortable with the product category.
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CEO Joe Jimenez told investors the firm is encouraged about the commercial prospects for CAR-T therapy. Lead drug CTL019 made Novartis' list of blockbusters in development after having been left off last year.
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
Kite Pharma investors were spooked on May 8 when the company revealed that an extremely ill patient died from cerebral edema related to its lead CAR-T candidate – the same severe side effect that derailed Juno's competing cell therapy.