US FDA committee recommends against fast-track approval of Clovis’ cancer drug, asks for more data

pharmafile | April 13, 2016 | News story | Medical Communications, Research and Development  

Shares in Clovis Oncology Inc (Nasdaq: CLVS) closed down 5.4% Tuesday after the US Food and Drug Administration advisory committee recommended against priority approval for its lung cancer drug.

The FDA committee has asked for further data on the trial drug rociletinib before making any decision on approvals.

Patrick Mahaffy, chief executive of Clovis Oncology, said: “We are disappointed with today’s outcome, as we believe in the strength of the data we presented for rociletinib. We will work with the FDA to evaluate the best path forward as it continues to review our application.”

The decision comes close on the heels of FDA staff raising doubts over the efficacy of the company’s trial drug for lung cancer against the existing treatments including AstraZeneca’s (LSE: AZN) Tagrisso (osimertinib), and raised concerns over its safety profile.

Tagrisso was granted accelerated approval by the FDA in November last year for certain patients with non-small-cell lung cancer (NSCLC).

Last week, the US regulators also recommended, if approved, the marketing label for rociletinib to include a warning about increased cardiovascular risk from the drug. The labelling should also include monitoring of the patient’s heart while under the treatment, the reviewers suggested. Stock dived nearly 18% following the news.

The US Food and Drug Administration will make a decision on, rociletinib, by June 28.

In November, Clovis said the FDA had asked for additional efficacy data for rociletinib. The drug candidate was granted breakthrough therapy status by the FDA in 2014.

Lung cancer is the second most common cancer in the US, with more than 200,000 new cases each year, and is the leading cause of cancer-related death. NSCLC accounts for almost 85% of lung cancers.

The stock closed down 5.4% to $14.24 Tuesday on the Nasdaq.

Anjali Shukla

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