Health and Healthcare

Clovis Gears Up for NDA Discussion in April

Chris Lange

Published: February 12, 2016 10:50 am

Last Updated: January 13, 2020 1:15 pm

Clovis Oncology Inc. (NASDAQ: CLVS) traded down in Friday’s session on a U.S. Food and Drug Administration (FDA) announcement. The company said that the FDA scheduled the New Drug Application (NDA) for rociletinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on April 12.

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

Ultimately, the ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

Patrick J. Mahaffy, president and CEO of Clovis, commented:

We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib. New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer.

Shares of Clovis were trading down almost 3% at $18.08 Friday morning, with a consensus analyst price target of $34.13 and a 52-week trading range of $17.76 to $116.75.