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%).
- 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).
- 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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