FDA panel recommends against accelerated approval of Clovis' cancer therapy rociletinib, requests additional data

An FDA advisory committee on Tuesday voted 12-1 recommending against the approval of Clovis Oncology's investigational lung cancer drug rociletinib. Specifically, the panel recommended that the agency await the results of the ongoing Phase III TIGER-3 trial before issuing a decision concerning the approval of the therapy.

In documents released ahead of the panel vote, FDA staff questioned whether rociletinib was more effective than existing treatments, including AstraZeneca's Tagrisso (osimertinib), which was granted accelerated approval by the FDA in November last year for certain patients with non-small-cell lung cancer (NSCLC). Panellists indicated that existing data on rociletinib does not adequately clarify its benefit-risk ratio compared to existing treatments, particularly in relation to Tagrisso, and questioned the proposed dose. Some of the committee members also expressed concerns regarding whether the ongoing late-stage study is adequately designed to address these questions.

Clovis CEO Patrick Mahaffy remarked "we are disappointed with today's outcome, as we believe in the strength of the data we presented for rociletinib," adding "we will work with the FDA to evaluate the best path forward as it continues to review our application." Meanwhile, patient enrolment in the TIGER-3 trial is expected to complete in late 2018, while the study is expected to conclude the following year.

Rociletinib was granted breakthrough therapy status by the FDA in 2014 for the second-line treatment of NSCLC in patients with the T790M mutation in EGFR. Meanwhile, the agency requested additional information from Clovis in November last year concerning the company's filing for the therapy.

For related analysis, see ViewPoints: Clovis' credibility questioned.

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