Clovis Oncology, Inc. 's CLVS shares touched a 52-week low of $15.75 on Apr 8 with the FDA raising concerns related to the company's experimental lung cancer treatment, rociletinib, in its briefing documents ahead of the review by its Oncologic Drugs Advisory Committee meeting. The company's shares slumped 17.7% on the news.
The FDA panel is scheduled to review the new drug application (NDA) for rociletinib tomorrow (Apr 12).
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.
Efficacy and Safety Concerns
In its briefing documents, the FDA has specially asked the advisory panel to consider whether Clovis' proposed recommended dose of 625 mg twice daily is supported by clinical and clinical pharmacology data. It has also questioned whether rociletinib is more effective than treatments already available and whether its benefit-risk profile is positive for the proposed patient population.
The briefing documents contain labeling recommendations regarding the inclusion of a boxed warning related to the risk of QTc (corrected QT interval) prolongation leading to Torsades de pointes and also include ECG monitoring of QTc interval at baseline and periodically when on rociletinib.
The FDA has also suggested that the labeling should carry warning and precautions subsections for QTc prolongation, hyperglycemia, interstitial ling disease/pneumonitis, pancreatitis, and cataracts. All these were identified as adverse reactions during the evaluation of safety of the candidate.
The FDA has also asked Clovis to submit a proposal for risk mitigation. The regulatory agency believes that a Risk Evaluation and Mitigation Strategy or other strategies may be required to reduce the risks of rociletinib and therefore ensure safe use.
We note that Clovis had faced a setback in Nov 2015 and shares were adversely affected when the FDA asked for additional data for analyzing the efficacy of rociletinib. The company submitted a major amendment to the NDA in the same month, which had pushed out the FDA action date for rociletinib further by three months.
Given that Clovis has no approved product in its portfolio at the moment, and rociletinib is the company's lead pipeline candidate, another delay in its approval will come as a huge blow for the company. A final response from the FDA is expected by Jun 28.
Investor focus is expected to remain on the outcome of the advisory panel meeting and the approval status of the candidate.
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 Actelion Ltd. ALIOF . All three stocks sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report