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CHMP Recommends Dabrafenib/Trametinib Combo in BRAF+ NSCLC

Jason M. Broderick @jasoncology
Published: Friday, Feb 24, 2017

Bruno Strigini, CEO

Bruno Strigini, CEO

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) as a treatment for patients with advanced or metastatic BRAF V600E-mutant non–small cell lung cancer (NSCLC). The positive opinion will now be reviewed by the European Commission and a final approval decision for use in the European Union is expected in about 2 months.

The most common all-grade AEs observed in the trial were pyrexia (46%), nausea (40%), vomiting (35%), diarrhea (33%), asthenia (32%), decreased appetite (30%), peripheral edema (23%), cough (21%), and rash (21%). The most common serious AEs were pyrexia (16%), anemia (5%), confusional state (4%), decreased appetite (4%), hemoptysis (4%), hypercalcemia (4%), nausea (4%), and squamous cell carcinoma of the skin (4%).
  1. Planchard D, Besse B, Groen HJM, et al. An open-label phase II trial of dabrafenib (D) in combination with trametinib (T) in patients (pts) with previously treated BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC; BRF113928). J Clin Oncol. 2016;34 (suppl; abstr 107).
  2. Dabrafenib plus trametinib in patients with previously treated BRAFV600E-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial [published online June 6, 2016]. Lancet Oncol. DOI: 10.1016/S1470-2045(16)30146-2.

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