Thirteen years after federal regulators last approved a new drug to treat advanced melanoma, the Food & 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 the possibility for controlling a disease that today is diagnosed in about 68,000 Americans annually and kills more than 8,700 people in this country each year.

"A year or two ago, melanoma treatment wasn't like it is in this moment," said Dr. Adil Daud, director of UCSF's Melanoma Program.

Zelboraf, approved Wednesday, attacks a genetic mutation found in about half of melanoma patients, inhibiting the disease's ability to spread. The drug, which comes in a pill, was developed by Berkeley's Plexxicon and is being marketed by South San Francisco's Genentech and Daiichi Sankyo.

A diagnostic test to determine whether patients carry the mutation was approved at the same time. Genentech officials said the approval process for the test, developed by Pleasanton's Roche Diagnostic Laboratories, 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."

Effective for some

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 therapies for melanoma work for less than 20 percent of patients, and some fall into single digits.

Mill Valley resident Anders Norlin, 55, who was diagnosed with melanoma in 1995, knew his options were running low after he had several recurrences of the disease and, two years ago, was diagnosed with late-stage melanoma. He underwent surgery and various treatments, but in April 2010 learned the disease had spread to a kidney.

It turned out Norlin had the mutation and was a candidate for the Zelboraf clinical trial. He began taking the drug in August 2010 and has seen his tumors shrink significantly or even disappear entirely.

"It's been working for me very well and I'm very fortunate I was selected for this trial," said Norlin, who runs a leasing company out of his home and is the married father of two young-adult daughters. "If I hadn't been, who knows what would happen."

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."

His oncologist, UCSF's Daud, is already considering Norlin and other patients for a second trial which would combine Zelboraf with another cancer-fighting agent now in the early testing phases.

"I don't pretend for a minute this is a panacea or a cure," Daud said. "There's a lot of work that needs to be done to figure how the response can be made durable or forever."

Early approval

Genentech officials said they expect Zelboraf to be available to patients in less than two weeks. The FDA approved the drug well ahead of expectations in 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 course of Yervoy treatment, which lasts three months.

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.

"Researchers turned AIDS from a death sentence to a chronic illness," said Turnham, executive director of the nation's largest advocacy group for melanoma research and patients. "Through a combination of drugs, that's what we hope will happen with melanoma."

About melanoma Melanoma, if not caught early, is the most deadly of all skin cancers and is the fastest-growing cancer in the United States and worldwide. Here are some facts: 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. Source: The Melanoma Research Foundation