Blue MedicareRx (PDP)^SM News
New skin cancer drug

Zelboraf (vemurafenib) is the second drug approved by the U.S. Food and Drug Administration [link to fda.gov] this year to treat advanced malignant melanoma, the most deadly form of skin cancer. The drug was approved in August, based on studies showing it improved the overall survival rates for people with late-stage melanoma who carry a certain genetic pattern called BRAF V600E.

Earlier this year, the FDA also OK’d Yervoy, a different type of drug, for use in late-stage melanoma.

“Late-stage” skin cancer is either inoperable or metastatic, meaning it has already spread to other parts of the body. The study that prompted the FDA to issue a “priority review” or fast-track approval for Zelboraf involved 675 previously untreated patients. With melanoma that couldn’t be cut out, they were given either Zelboraf or dacabarzine, an already-approved anti-cancer treatment. According to an Aug. 17, 2011 FDA news release, 77 percent of patients were still living after eight months, versus 64 percent of those who took dacabarazine.

In the news release, the FDA also announced approval of a “first-of-a-kind test” to determine if melanoma cells contain a mutated protein (BRAF V600E) signaling the cells have lost their ability to regulate growth. Uncontrolled growth can lead to skin cancer.

Zelboraf works by blocking the cancer-causing function of the mutated BRAF V600E protein, FDA officials reported.

Return to front page