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FDA extends review period for ipilimumab

The US FDA has determined that additional time is required to complete the review of the biologics licence application for BMS' ipilimumab

Bristol-Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics licence application (BLA) for ipilimumab, which is used for pre-treated advanced melanoma.

The decision date has been moved from December 25, 2010 to March 26, 2011.

In response to an FDA request, BMS submitted further analysis of data pertaining to the current application for pre-treated advanced melanoma, and FDA considers this to be a major amendment to the drug's BLA.

BMS has said that it continues to be very encouraged by its interactions with the FDA and remains confident in the overall development programme for ipilimumab.

Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities worldwide for pre-treated advanced melanoma.

3rd November 2010

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