GlaxoSmithKline has filed its two newly-approved drugs Tafinlar and Mekinist to be used in combination for melanoma with regulators in the USA.
Supplemental New Drug Applications have been made to the US Food and Drug Administration for use of Tafinlar (dabrafenib), a BRAF inhibitor, in combination with Mekinist (trametinib), a MEK inhibitor for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The files are based on data from a Phase I/II study comparing dabrafenib monotherapy to the combo.
The move has surprised analysts somewhat as GSK was expected to file the combo later in the year when Phase III data is expected to be published. Tafinlar and Mekinist were approved by the FDA in May, along with a companion diagnostic made by French firm bioMerieux.
The two drugs were under an accelerated review by the European Medicines Agency, but the latter’s Committee for Medicinal Products for Human Use (CHMP) has now reverted to a standard review for trametinib, both as monotherapy and in combination with dabrafenib to allow sufficient time to study the submission.
GSK has also entered into a research collaboration and licensing agreement with the UK’s Immunocore to develop novel biologics to treat cancer and viral disease.
Immunocore has created what it calls “a world-leading platform of bi-specific biological drugs”, called ImmTACs. They “exploit the power of T cell receptors to recognise intracellular changes that occur during cancer or viral infection”. The Oxford-based firm will receive up to £142 million in pre-clinical milestone payments across the targets and for each product that reaches the market, up to £200 million is due to Immunocore, plus up to double-digit royalties.
The deal comes a fortnight after Immunocore signed a similar collaboration with Roche’s Genentech unit.
