Melanoma patients will be disappointed by the news that GlaxoSmithKline has withdrawn its filing in Europe for an eagerly-watched combination treatment for the deadliest form of skin cancer.
The UK major has pulled its marketing application to the European Medicines Agency for the use of its MEK inhibitor Mekinist (trametinib) in combination with the BRAF inhibitor Tafinlar (dabrafenib) for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation. The combo was approved in the USA in January.
However the Committee for Medicinal Products for Human Use (CHMP) of the EMA has indicated that the data provided to date by GSK did not allow it to conclude on a positive benefit-risk balance of the combination. Therefore the company intends to re-submit the file on the combo when additional data from the ongoing Phase III programme become available.
The application for the use of Mekinist as a single agent in the same patient population is still undergoing review by the EMA. Rafael Amado, head of oncology R&D at GSK, said that “while significant progress has been made in treating metastatic melanoma over the last few years, we believe more treatment options are needed, and we will work with the European regulators towards making the combination available”.
