Thirteen years after federal regulators last approved a new drug to treat advanced melanoma, the Food and Drug Administration has given the green light to two revolutionary drugs in the past five months to treat the deadliest form of skin cancer.
Researchers say the developments make this an exciting time for those who see possibility for controlling the disease. Each year in the U.S., melanoma is diagnosed in 68,000 people and it kills more than 8,700.
Zelboraf, which comes in a pill and was approved Aug. 17, attacks a genetic mutation found in about half of melanoma patients, inhibiting the disease's ability to spread.
A diagnostic test to determine whether patients carry the mutation was approved at the same time. Genentech officials, who are marketing the drug, said the approval process for the test and the drug -- five years from start to finish -- marked the fastest approval for any drug in the company's history.
In March, the FDA approved another late-stage melanoma treatment, Bristol-Myers Squibb's Yervoy, which acts to trigger the body's anticancer immune response.
"For people with metastatic melanoma, their life expectancies have been measured in months," said Genentech spokeswoman Krysta Pellegrino. "In the past year, you have two new medicines that are completely new types of medicine."
Yervoy was found to extend patients' lives, an improvement over many current treatments. However, the drug works for less than 20 percent of patients, and doctors say they can't predict which patients will find it most effective.
Zelboraf was clinically effective in 50 percent of patients who had a specific genetic mutation called BRAF V600E. Most of the melanoma therapies work for less than 20 percent of patients.
Californian Anders Norlin, who was diagnosed with melanoma in 1995, knew his options were running low. Two years ago, he was diagnosed with late-stage melanoma. He began taking Zelboraf in August 2010 and has seen his tumors shrink significantly or even disappear entirely.
Norlin described his side effects as relatively mild: joint pain, skin hardening and hair loss. He's pleased with the result but aware of the drug's potential limitations: "There's nothing that says this medication will help you forever."
Genentech officials said they expect Zelboraf to be available to patients soon. The FDA approved the drug well ahead of schedule; the target was late October.
Both Zelboraf and Yervoy are expensive. Zelboraf will cost $9,400 a month -- $56,000 for a standard six-month course of treatment, according to Genentech. Bristol-Myers said it would charge $120,000 for a complete, three-month course of Yervoy.
Tim Turnham of the Melanoma Research Foundation said he expects insurers to cover the cost of life-saving drugs, especially for cancer patients who -- until now -- have had very few options.
If not caught early, melanoma is the most deadly of all skin cancers and is the fastest-growing cancer in the U.S. and worldwide, according to the Melanoma Research Foundation. It shared other information:
Risk: One in 50 Americans has a lifetime risk of developing melanoma.
Frequency: Melanoma is the most common form of cancer for young adults 25 to 29.
Location: Melanoma is often seen on the skin, but can also develop in the eye, digestive tract, brain or spinal cord, or other areas where melanocytes, or pigment cells, are found.
Other types: Non-melanoma skin cancers are usually referred to as basal cell carcinoma and squamous cell carcinoma. These skin cancers are most often treated with surgery because they do not normally spread to other parts of the body.
The Genentech Access to Care Foundation provides free medicine to uninsured patients. Patients with questions or concerns about insurance coverage for Genentech drugs can call (888) 249-4918 or visit www.GenentechAccessSolutions.com.