Clovis Gets Breakthrough Therapy Designation - Analyst Blog

The U.S. Food and Drug Administration (FDA) grants Breakthrough Therapy designation to candidates that show potential superiority over existing therapies for the treatment of serious or life threatening diseases or conditions.

The Breakthrough Therapy designation is a status provided under the 2012 FDA Safety and Innovation Act. The designation helps to expedite the development and review process for experimental drugs targeting serious and life-threatening diseases. A candidate with Breakthrough Therapy designation could benefit from the FDA's existing fast track development program features as well as more intensive FDA guidance on efficient development of the candidate.

Ever since the Act came into effect, quite a few pipeline candidates have received Breakthrough Therapy designation from the FDA. Recent recipients include Bristol-Myers Squibb Company's BMY oncology candidate, nivolumab, for the treatment of patients suffering from Hodgkin lymphoma as well as Clovis Oncology, Inc.'s CLVS oncology candidate CO-1686.  

Clovis Oncology is developing CO-1686 as a monotherapy for the treatment of patients suffering from second-line epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) with T790M mutation.

Currently, the enrollment process for two phase II expansion cohorts of a phase I/II study on CO-1686 for EGFR mutant NSCLC patients with the T790M mutation is ongoing. The company plans to submit a New Drug Application (NDA) to the FDA for CO-1686 by mid 2015.

The company stated that NSCLC accounts for 85% of all lung cancer, which is the most common cancer with 1.7 million new cases diagnosed annually. The NSCLC market is heavily crowded with the presence of many other EGFR inhibitors like Roche's (RHHBY) Tarceva.

Clovis Oncology carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Gilead Sciences Inc. GILD carrying a Zacks Rank #1 (Strong Buy).