* FDA action date on ipilimumab delayed until March 26
* Bristol says submitted further data analysis to FDA
NEW YORK, Nov 2 (Reuters) - A U.S. approval decision on Bristol-Myers Squibb Co's BMY.N highly promising experimental drug for advanced melanoma has been delayed by three months to give regulators more time to review data on the medicine, the company said on Tuesday.
The Food and Drug Administration is now scheduled to make its decision on the drug, ipilimumab, by March 26. The original FDA action date had been Dec. 25, Bristol-Myers said.
The FDA determined it needed more time to review the ipilimumab marketing application after Bristol-Myers submitted further analysis of data that had been requested by the agency. The FDA considered the additional analysis to be a major amendment to the drug’s marketing application, Bristol-Myers said.
Leerink Swann has forecast ipilimumab sales of $575 million in 2016 with an approval for metastatic melanoma, one of the deadliest of all cancers.
Bristol-Myers said it has been encouraged by its interactions with the FDA and remains confident in the drug’s development. The company is also awaiting a European approval decision on ipilimumab.
In a study presented at a major medical meeting in June, patients with advanced melanoma who received ipilimumab on average lived four months longer than those who were treated with a vaccine. The one- and two-year survival rate was nearly double for ipilimumab patients in the clinical trial.
Ipilimumab is a biotechnology drug that helps to activate the immune system’s T-cells to fight the cancer.
Once melanoma spreads the average survival is six to nine months, researchers said. There are currently no really effective treatments for patients who have had prior treatment for melanoma. (Reporting by Bill Berkrot; Editing by Gary Hill)
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