Last month, the FDA approved the drug Zelboraf (vemurafenib) for patients with melanoma, the deadliest form of skin cancer. The drug is designed to work only for late-stage melanoma patients whose tumors have a specific genetic defect known as the BRAF V600E mutation, which is present in approximately half of melanoma cases. The FDA also approved a diagnostic test that determines whether a patient's melanoma cells have this mutation.
The drug is the second to be approved this year for patients with late-stage melanoma -- Yervoy (ipilumumab) was approved last March. These approvals are an important advance, given the dearth of treatment options for late-stage melanoma.
Unfortunately, neither drug is a cure for the disease. Clinical trials have revealed that Zelboraf extends survival by a few months on average, compared with those taking traditional chemotherapy. What's more, it comes with a hefty price tag of about $9,400 per month.
To read more about the initial trials of Zelboraf (originally known as PLX4032) in humans and the path of this drug to market, see this fascinating series of articles by The New York Times reporter Amy Harmon.