FDA advisory recommends against accelerated approval for Clovis's rociletinib

13 April 2016

USA-based biopharma company Clovis Oncology (Nasdaq: CLVS) has suffered a major setback as it seeks approval for lung cancer drug rociletinib.

The US Food and Drug Administration Oncologic Drugs Advisory Committee has recommended against granting the company’s request for accelerated approval for the drug.

Instead the panel, which met on Tuesday, has urged the FDA to wait to see results from TIGER-3, Clovis’ ongoing Phase III, randomized, controlled trial of rociletinib, before making a decision on approval of the treatment.

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