publication date: Feb. 3, 2014


CCL37-01j.html

FDA News

FDA Grants Accelerated Approval To Mekinist-Tafinlar Combination


FDA granted accelerated approval for Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations.

The approval was based on the demonstration of response rate and median duration of response in a phase I/II study, and is dependent on the results of an ongoing phase III trial (MEK115306 or Combi-D). The combination was reviewed under a Priority Review designation.

Improvement in disease-related symptoms or overall survival has not been demonstrated for Mekinist in combination with Tafinlar. The BRAF mutations must be detected by an FDA-approved test. Tafinlar is not indicated for treatment of patients with wild-type BRAF melanoma.

In the phase II portion of the open-label study, the main efficacy endpoint of overall response was 76 percent for patients treated with the combination (n=54; 95% CI, 62, 87), and 54 percent for patients treated with single-agent Tafinlar (n=54; 95% CI, 40, 67).

The median duration of response was 10.5 months for patients treated with the combination (95% CI, 7, 15), and 5.6 months for patients treated with single-agent Tafinlar (95% CI, 5, 7). When enrolling patients, no more than one prior chemotherapy regimen and/or interleukin-2 was permitted. Patients with prior exposure to BRAF inhibitors or MEK inhibitors were ineligible.

Mekinist and Tafinlar are both sponsored by GlaxoSmithKline.


FDA granted 510(k) clearance to Royal Philips’s Spectral Breast Density Measurement Application for its MicroDose SI full-field digital mammography system. The application is the first spectral breast density measurement tool, meaning adipose and glandular tissue can be … Continue reading CCL Jan – FDA News

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