GlaxoSmithKline said Monday that the FDA granted priority review designation to filings seeking approval of the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adults with unresectable or metastatic melanoma who also carry BRAF V600 E or K mutations. In May, the agency approved the two oral drugs for use separately.
The company noted that the applications are based on data from a Phase I/II study comparing combination therapy with Tafinlar and Mekinist to Tafinlar alone in adults with BRAF V600 E and K mutation-positive metastatic melanoma. According to GlaxoSmithKline, the FDA is scheduled to make a decision on the supplemental applications for the MEK inhibitor Mekinist and the BRAF inhibitor Tafinlar next year by January 8 and 9, respectively.
Tafinlar was cleared by the European Commission earlier this month as monotherapy for unresectable or metastatic melanoma in adults who express the BRAF V600 E gene variant as detected by a validated test. A filing seeking approval of the Tafinlar and Mekinist combination was submitted to European regulators in February and is currently under review, along with an application for Mekinist as monotherapy
For related analysis, see ViewPoints: Regulatory momentum grows for GlaxoSmithKline's oncology portfolio.
To read more Top Story articles, click here.