Melanoma drug likely to get OK this week

By Reuters
Posted March 23 at 12:41 p.m.

Bristol-Myers Squibb may win U.S. approval as early as this week for the first drug shown to extend survival for patients with a deadly form of skin cancer.

Industry analysts say it is likely the medicine, ipilimumab, will win clearance by a Saturday deadline for patients who previously tried other melanoma treatments.

A Thomson Reuters consensus forecast of four analysts calls for ipilimumab sales to reach about $820 million in 2015.

In a company study of 676 patients, ipilimumab extended survival by an average of four months, a result seen as a major advance for a disease with limited treatment options and a string of drug failures. Patients who got the drug lived an average of 10 months, compared with just over six months if they got an experimental treatment called GP-100.

The Food and Drug Administration in November delayed a final decision on ipilimumab to further review data on the medicine.

The drug is forecast to become a major product for Bristol-Myers. Sanford Bernstein analyst Tim Anderson, in a research note, predicted global sales of $1.7 billion in 2015, or 10 percent of the company’s total sales and higher than the Thomson Reuters consensus.

Advanced melanoma is one of the deadliest cancers and can quickly spread from the skin to internal organs, such as the brain. Once melanoma spreads the average survival is typically six to nine months.

Ipilimumab or “ipi” is an engineered version of a human protein that targets CTLA-4, a molecule that acts like a brake on the immune system. By gumming up the brake, the drug unleashes the immune system to seek and destroy tumors.

The Bristol-Myers drug is given in a 90-minute infusion every three weeks for a total of four doses.

The treatment carries a risk for serious side effects. About 2 percent to 3 percent of patients on ipilimumab died from the treatment because of colon perforation or severe immune system complications.

The FDA will decide whether to clear ipilimumab for patients previously treated for melanoma. Bristol-Myers also announced this week the drug worked in advanced melanoma patients who had not yet tried other options.

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