FDA staff raises doubts on efficacy, safety of Clovis’ trial drug for lung cancer, shares plunge

pharmafile | April 11, 2016 | News story | |  AstraZeneca, Clovis Oncology, US FDA, drug trial, lung cancer, regulation, rociletinib 

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.

Anjali Shukla

Related Content


AstraZeneca launches health-tech business, Evinova

AstraZeneca has announced that it has launched Evinova, its new health-tech business, which it is …

FDA approves AstraZeneca’s Truqap plus Faslodex for breast cancer treatment

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Truqap (capivasertib) …

FDA approves BMS’s Augtyro for lung cancer treatment

Bristol Myers Squibb has announced that the US Food and Drug Administration (FDA) has approved …

Latest content