GlaxoSmithKline (GSK) announced today that the US Food and Drug Administration (FDA) has, for the first time, approved the use of Mekinist in combination with Tafinlar. The combination will be used to treat patients with melanoma that cannot be surgically removed or that has spread to other parts of the body.
Dr Paolo Paoletti, president of oncology at GSK commented:
This approval marks another key moment in what continues to be a rapid evolution of the treatment landscape for metastatic melanoma patients. Combining agents that target different mechanisms regulating the growth of cancer cells is one of the promising areas in cancer research.
In the US alone more than 8,000 people die of melanoma each year, with 68,000 of the one million diagnoses of skin cancer caused by melanoma.
The combination was approved through the FDA's Accelerated Approval programme and reviewed under a Priority Review designation. However, the results will be contingent on the results ongoing phase III trial.
The FDA was also the bearer of good news for multinational pharmaceutical firm Astrazeneca, confirming that the use of farxiga tablets have been approved to assist with glycemin control.