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Clovis Drops, FDA Panel Seeks More Data on Rociletinib

Clovis Oncology, Inc.’s CLVS shares plunged to a new 52-week low of $12.25 on Apr 12 and eventually closed at $14.24 with the FDA’s Oncologic Drugs Advisory Committee asking the company for additional data on its experimental lung cancer treatment, rociletinib. Overall, the company’s shares dropped 5.4% on the news.

Clovis is looking to get rociletinib approved for the treatment of patients with epidermal growth factor receptor (EGFR) mutation positive metastatic non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and who have the EGFR T790M mutation as detected by an FDA approved test.

The FDA panel recommended the regulatory agency that before giving a verdict on the approval of rociletinib, it should wait for results from the company’s ongoing randomized, controlled phase III study (TIGER-3) on the candidate. Enrollment of patients is expected to be completed in late 2018.

The opinion rendered by the FDA panel was to a great extent expected following the efficacy and safety concerns that were raised in the briefing documents ahead of the panel meeting (read more: Clovis Hits 52-week Low Post Rociletinib Briefing Documents).

Clovis intends to work closely with the FDA to facilitate the approval of the new drug application. If the FDA follows the panel’s recommendation, it would be a major blow for the company. A response from the FDA is expected by Jun 28.

Considering that Clovis has no approved product in its portfolio at the moment and rociletinib is its lead pipeline candidate, the delay in its approval is weighing heavily on the company’s prospect.

Clovis is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Emergent BioSolutions, Inc. EBS and Gilead Sciences Inc. GILD. All three stocks sport a Zacks Rank #1 (Strong Buy).

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