FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge
Shares in Clovis Oncology Inc (Nasdaq: CLVS) plunged to close down nearly 18% after the US regulators expressed doubts if the company’s drug candidate to treat lung cancer was more effective than existing treatments and raised concerns over its safety profile.
The trial drug, rociletinib, is targeted at treating a category of patients with advanced non-small cell lung cancer whose disease has worsened despite treatment.
UK-based AstraZeneca Plc’s (LSE: ANZ) Tagrisso is prescribed as treatment in similar indication.
The US Food and Drug Administration will make a decision on, rociletinib, by June 28. If approved, the FDA has also recommended the marketing label for the drug 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 have suggested.
In November, Clovis said the FDA had asked for additional efficacy data for rociletinib.
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.
Shares of Clovis closed down 17.7% to $15.77 Friday on the Nasdaq.
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