The European Medicines Agency (EMA) has granted GlaxoSmithKline’s (GSK) melanoma drug an accelerated review. The melanoma drug, a MEK inhibitor named trametinib, is requesting a European licence as both a monotherapy and in combination with their investigational BRAF inhibitor dabrafenib, for the medication of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Merck have suffered a hindrance this week with the withdrawal of their Marketing Authorization Application for ridaforolimus in Europe. The European Medicines Agency (EMA) was evaluating ridaforolimus as a possible maintenance treatment for patients with soft tissue sarcoma or primary malignant bone tumour. Merck have licensed the drug, an M-TOR inhibitor from Ariad Pharmaceuticals.
Boehringer Ingelheim announced earlier today that they have submitted their first oncology compound, afatinib, to European regulators. The German firm filed a marketing authorisation application to the European Medicines Agency (EMA) for the approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Boehringer confirmed that afatinib
Takeda Pharmaceutical announced today that the European Medicines Agency (EMA) has agreed to review their type 2 diabetes treatment, alogliptin, a month after receiving a negative response for the therapy from the US FDA (Food and Drug Administration). The Japanese drug maker received confirmation of the acceptance of the proposal of a marketing authorisation application