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Celgene and Agios to file FDA application for “first-in-class” cancer drug

Published on 08/09/16 at 09:22am

According to an SEC 8-K filing by Agios, the company and its partner Celgene intend to file a new drug application (NDA) for a “first-in-class” cancer drug, intended to treat relapsed or refractory acute myeloid leukaemia. The NDA is expected to be filed before the end of the year.

AG-221 (enasidenib) is currently in Phase I/II trials for patients with a specific mutation of acute myeloid leukaemia, called isocitrate dehydrogenase 2 (IDH2). The NDA will rely on data from this early stage trial. In total, data on cohorts numbering 225 patients will be submitted as part of the application.

Celgene own the rights to AG-221, while Agios will be eligible for significant royalties upon regulatory approval. The pair will also seek approval next year for AG-221 to treat patients with IDH1 mutation.

Agios also indicates that it provide a “regulatory update” on AG-120 by the end of 2016. Celgene, however, has already cut its stake in this other drug after initially promising Phase I data was viewed poorly by investors.

Shares at Agios have risen over a quarter since the filing emerged, now boasting a market cap of $1.84 billion. Celgene’s rose more modestly, up a quarter of a percent to $106.96 per share.

Sean Murray

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