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# Panel Gives Thumbs Down to Clovis Lung Cancer Drug
- URL: https://www.fdaweb.com/panel-gives-thumbs-down-to-clovis-lung-cancer-drug/
- Published: 2016-04-12T12:00:00.000Z
- Updated: 2026-09-14T20:53:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135341

> FDA’s Oncologic Drugs Advisory Committee 4/12 voted 12 to 1 to not recommend accelerated approval for a Clovis Oncology NDA for rociletinib tablets and its use in treating 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 as confirmed by an FDA-approved test. The panel recommended that the agency wait to see results from the company’s TIGER-3 Phase 3, randomized, controlled trial before making a decision on the submission’s approval. Patient enrollment for the trial is expected to complete in late 2018.  
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> The NDA was supported by data from two single-arm clinical trials that measured objective response rates and durations of response. Panel members said they were challenged to find a favorable benefit/risk profile based on single-arm studies, and they were concerned about reports about QT prolongation and hyperglycemia seen in clinical development.  
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