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PDUFA March 30 2016 of Rociletinib for mutant EGFR T790M-positive lung cancer. Delay possible due to release of data during review cycle of much lower than expected overall response rates

Source Link:: http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-newsArticle&ID=2112606

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Additional Information

Additional Relevant Details In the intent to treat analysis of the 79 patients in the 500mg dose group, the current confirmed response rate is 28 percent, and 34 percent in the 170 patients in the 625mg dose group, with an encouraging duration of response in both doses. The most frequent reasons that patients’ responses were not confirmed in a subsequent scan were due to progression, often due to brain metastasis, and due to subsequent scans not demonstrating tumor shrinkage greater than 30 percent.

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Additional Relevant Details
The Committee recommended that the FDA wait to see results from TIGER-3, Clovis’ ongoing Phase 3, randomized, controlled trial of rociletinib, before making a decision on approval of the treatment. Patient enrollment for the trial is expected to complete in late 2018.

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Catalyst Date

Occurred on:

Apr 12, 2016

Occurred Source:

http://phx.corporate-ir.net/phoenix.zhtml?c=247187&p=irol-newsArticle&ID=2156480

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Related Keywords Rociletinib, Nda, Fda, Egfr T790m-positive Lung Cancer