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FDA Requests Additional Data for Rociletinib in EGFR T790M-Mutant NSCLC

Silas Inman @silasinman
Published: Monday, Nov 16, 2015

Patrick J. Mahaffy

Patrick J. Mahaffy

The FDA has requested additional clinical trial data to support a new drug application (NDA) for rociletinib (CO-1686) as a potential therapy for pretreated patients with EGFR T790M mutation-positive non–small cell lung cancer (NSCLC), according to a statement from the drug's developer, Clovis Oncology.

Sequist LV, Goldman JW, Wakelee HA, et al. Efficacy of rociletinib (CO-1686) in plasma-genotyped T790M-positive non-small cell lung cancer (NSCLC) patients (pts). J Clin Oncol. 2015;33 (suppl; abstr 8001).

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