A cancer drug that yielded remarkable results against a seemingly intractable disease has earned an early approval from the US Food and Drug Administration (FDA). Today, regulators announced that vemurafenib (the drug formerly known as PLX4032) will be available for use against advanced melanomas that have a mutated B-RAF protein.

Clinical trials showed that the drug shrank tumours and improved survival (see ‘Rare victory in fight against melanoma’). Those results spurred quick action by the FDA, which issued its approval two months before the drug’s “PDUFA date” – an approximate target date for a decision that is based on when a drug’s maker filed for approval. The FDA also approved a genetic test that will be used to identify cancers with the B-RAF mutation.

The vemurafenib saga began in 2002, when researchers reported the B-RAF mutation in over 60% of melanomas. Plexxikon, a Berkeley, California biotech, jumped on the finding and later brought in the Swiss pharmaceutical firm Roche as a partner in developing the drug. (Plexxikon was bought earlier this year by Daiichi Sankyo, a Japanese pharmaceutical company for up to $935 million.) Meanwhile, researchers at other pharma firms are busy developing their own B-RAF inhibitors, and testing them in combination with additional therapies in hopes of warding off drug resistance (see ‘The roots of resistance’).