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Roche, Daiichi Sankyo Win U.S. Approval for Melanoma Drug

Roche Holding AG and Daiichi Sankyo Co. won U.S. clearance to sell a pill for melanoma that is among a new wave of medicines developed to fight the deadliest form of skin cancer.

The Food and Drug Administration approved Zelboraf as a therapy for patients whose tumors have spread or can’t be removed surgically, the agency said today in a statement. The drug, also known as vemurafenib, is the second cleared for the disease this year.

Zelboraf may help patients with advanced melanoma, an aggressive skin cancer blamed for 8,700 U.S. deaths last year. The drug from Roche, of Basel, Switzerland, and Tokyo-based Daiichi will compete with Bristol-Myers Squibb Co.’s Yervoy, cleared in March as the first treatment proven to extend lives of advanced melanoma patients.

“This has been an important year for patients with late-stage melanoma,” Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. “Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival.”

Roche’s American depositary receipts gained 69 cents, or 1.7 percent, to $42.04 at 4 p.m. in New York Stock Exchange composite trading. Each receipt equals one-quarter of a regular share. Daiichi’s receipts, each representing one ordinary share, gained 1 cent to $19.50 in over-the-counter trading.

Projected Sales

Sales of Zelboraf may reach 700 million Swiss francs ($886 million) by 2015, Jack Scannell, an analyst with Sanford C. Bernstein & Co. in London, said today in a note to investors. Bristol-Myers, based in New York, may earn $1.5 billion from Yervoy in 2015, according to the average estimate of three analysts surveyed by Bloomberg.

GlaxoSmithKline Plc is among other companies testing drugs targeting genetic variations related to melanoma.

Zelboraf attacks a mutated gene that fuels tumor growth in about half of advanced melanoma patients. A company-funded trial showed the twice-daily pill worked better than chemotherapy infusions in prolonging survival and shrinking tumors among people with the mutation, according to a June 30 report in the New England Journal of Medicine.

After six months, 84 percent of the patients who took Zelboraf were still alive, compared with 64 percent of those treated with chemotherapy, the study found. A reduction in tumor size was seen in 48 percent of patients in the Zelboraf group and 5 percent in the chemotherapy group.

‘Paradigm Shift’

The drug’s approval is “a paradigm shift in the treatment of this disease,” said Antoni Ribas, an oncologist at the University of California in Los Angeles, in an e-mail. “For the first time we have a treatment that works in a reproducible way based on an in-depth understanding of what makes the melanoma cancer cell grow and how we can block it.”

The FDA, in clearing the drug, also approved a companion diagnostic test to help determine if a melanoma patient has the mutation.

“The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options,” Hal Barron, chief medical officer and head of Global Product Development at Roche’s Genentech unit, said today in an e-mail.

More than 68,000 Americans were diagnosed with melanoma last year, according to the National Cancer Institute in Bethesda, Maryland. The five-year survival rate is 15 percent among patients diagnosed after the cancer has spread. When caught in its early stages, the disease has a 98 percent survival rate after five years.

Combination Study

Roche and Bristol-Myers are collaborating to study whether a combination of Zelboraf and Yervoy works better than either drug alone. Yervoy works by spurring the immune system to attack cancer cells.

“As Yervoy is an immunotherapy, it could be complementary to Zelboraf rather than a straightforward either/or competitor,” Scannell said. “However, in the absence of data looking at the two drugs combined, they are initially likely to compete against each other.”

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