PREVIEW-Bristol-Myers melanoma drug may soon hit US market
* Drug is first to extend survival in advanced melanoma
* FDA ruling due by Saturday
* $820 mln in sales in 2015 - Thomson Reuters forecast
By Lisa Richwine
WASHINGTON, March 23 (Reuters) - Bristol-Myers Squibb (BMY.N) 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 use more time to 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, a figure representing 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 to other organs 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 promise of ipilimumab has created new hope for people in the advanced stages of melanoma.
Patients "have watched year after year after year as treatments have failed. This time it didn't. From that perspective, it's really exciting," said Tim Turnham, executive director of the Melanoma Research Foundation.
But he added that the Bristol-Myers drug did not work for everyone and patients still need more options. "We all know that it's not a home run," Turnham said.
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 earlier this week the drug worked in advanced melanoma patients who had not yet tried other options. [ID:nN22142544] (Reporting by Lisa Richwine; Editing by Dave Zimmerman)
- Tweet this
- Share this
- Digg this