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FDA panel says no to quick approval of Clovis' rociletinib

Recommends waiting for phase III trial results after "serious" safety concerns

An FDA advisory committee all but dashed any hopes that Clovis Oncology had for quick approval of its lung cancer drug rociletinib yesterday.

By a 12 to 1 vote, the panel recommended that the US regulator wait for the results of an ongoing phase III trial of rociletinib before delivering a verdict on the drug.

In a statement, Clovis confirmed that the FDA had heeded its panel's advice and would delay a verdict on rociletinib until the trial - called TIGER-3 - completes in 2019. Patient enrolment for the trial is expected to complete in late 2018.

Trading in the company was halted in advance of the advisory committee meeting in recognition that its outcome will have a big effect on the company's near-term prospects.

Rociletinib is under review for the treatment of non-small cell lung cancer (NSCLC) patients whose tumours are epidermal growth factor receptor (EGFR) positive and carry the T790M resistance mutation.

The drug is a third-generation EGFR inhibitor designed for use when other drugs in the class - Roche/Astellas' market-leading Tarceva (erlotinib), AstraZeneca's Iressa (gefitinib) and Boehringer Ingelheim's second-generation drug Giotrif (afatinib) - lose their efficacy.

Around 20% of patients are resistant to first-generation EGFR inhibitors from the outset and in nearly all cases resistance emerges within a year thanks to genetic mutations. T790M is the most commonly encountered and observed in around two-thirds of all cases.

Clovis was always fighting an uphill battle as documents published by the FDA ahead of the panel indicated it had serious concerns about the drug's safety - particularly with regard to possible cardiovascular effects. The agency also questioned a decision by the company to raise the dose used in some patients above that specified in its marketing application.

All told, around half of all patients treated with the drug experienced an adverse event, and 17% of those on the highest dose tested (625mg) died after reporting a side effect.

"We are disappointed with [the FDA panel] outcome, as we believe in the strength of the data we presented for rociletinib," said Patrick Mahaffy, Clovis' chief executive.

"We will work with the FDA to evaluate the best path forward as it continues to review our application."

Clovis' fortunes contrast with those of AZ, which won approval for its own third-generation EGFR inhibitor Tagrisso (osimertinib) last November for patients with T790M resistance mutations. Meanwhile Boehringer has a new EGFR inhibitor called BI 1482694 in the pipeline that could now also reach the market ahead of rociletinib.

With that in mind, Clovis has already come under pressure to drop rociletinib and focus on other candidates in its pipeline rather than to continue ploughing resources into what looks set to become a minor drug at best.

The company has PARP inhibitor rucaparib in phase III trials for ovarian cancer and multikinase inhibitor lucitanib in phase II for breast cancer.

Article by
Phil Taylor

13th April 2016

From: Regulatory



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