UPDATE 1-FDA decision on Bristol-Myers cancer drug delayed

* FDA action date on ipilimumab delayed until March 26

* Bristol says submitted further data analysis to FDA

NEW YORK, Nov 2 (BestGrowthStock) – 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)

UPDATE 1-FDA decision on Bristol-Myers cancer drug delayed