Clovis Oncology, Inc. CLVS announced that the review period for rociletinib has been extended by three months by the FDA. A final decision from the regulatory authority is now expected on Jun 28, 2016.
Clovis is looking to get rociletinib approved for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who were previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
We note that in May 2014, FDA granted Breakthrough Therapy designation to rociletinib. Meanwhile, the company has also submitted a marketing authorisation application for rociletinib in the EU for the same indication. A final decision is expected in mid-2016.
Why the Delay?
The FDA extended the candidate’s review period after the company submitted a major amendment in response to the FDA’s request for additional data for both the 500-mg and 625-mg twice-daily dosage patient groups for analyzing the efficacy of its lead pipeline candidate, rociletinib. (Read More: Clovis Crashes 70%, FDA Seeks More Data on Rociletinib)
With the delay in rociletinib’s approval weighing on Clovis’ prospects, however, AstraZeneca AZN stands to gain. Earlier this year, AstraZeneca gained accelerated approval in the U.S. for Tagrisso (80 mg once-daily) for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, and who have progressed on or after EGFR tyrosine kinase inhibitor therapy. This makes Tagrisso the only drug to be approved for metastatic EGFR T790M mutation-positive NSCLC.
Clovis is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Corcept Therapeutics Incorporated CORT, both sporting a Zacks Rank #1 (Strong Buy).
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