BMS skin cancer drug hits US regulatory delay
pharmafile | November 3, 2010 | News story | Research and Development | BMS, Bristol-Myers Squibb, FDA, MDX010-020 trial, ipilimumab, skin cancer
US regulators have announced they need more time to assess Bristol-Myers Squibb’s skin cancer treatment ipilimumab.
The FDA will not now make a decision on BMS’s biologics license application (BLA) for the drug in pre-treated advanced melanoma until the end of March.
The FDA put it up for priority review and had been due to make its decision by Christmas Day – but new information sent by the manufacturer is slowing things down.
BMS says this was “further analysis of data pertaining to the current application”, but adds that the FDA “considers this to be a major amendment to the drug’s BLA”.
The filing was based on the MDX010-020 trial, showing the drug extended average survival from 6.4 months to 10.1 months.
The novel T-cell potentiator blocks the inhibitory signal of CTLA-4 (cytotoxic T lymphocyte-associated antigen 4), a molecule on T-cells which plays a critical role in regulating natural immune responses.
Suppression of CTLA-4 can augment the immune system’s T-cell response. But studies have also shown ipilimumab can cause immune-related side effects, including severe and life-threatening adverse events affecting the gastrointestinal, skin, liver or endocrine systems.
The company will be on tenterhooks for the FDA’s decision, whenever it comes, since analysts say the drug could reach peak annual sales of $1-1.5 billion.
There are currently few treatment options for melanoma and BMS is putting a brave face on the FDA’s delay, saying it “continues to be very encouraged by its interactions” with the regulator.
The drug is currently being reviewed by the European Medicines Agency and other health authorities for the treatment of adult patients with previously treated advanced melanoma.
BMS “remains confident in the overall development programme for ipilimumab”, it insists, and “looks forward to continuing its close collaboration with the FDA on this application”.
The manufacturer gained rights to ipilimumab following its $2.1 billion acquisition of human antibody drug discovery firm Medarex last year.
Melanoma is more difficult to treat once the disease has spread beyond the skin by way of the bloodstream or the lymphatic system and its incidence has increased ten-fold over the past 50 years.
Last year Onyx Pharmaceuticals and its development partner Bayer stopped a phase II trial of Nexavar in patients with late-stage melanoma, citing a lack of efficacy.
Adam Hill
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