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FDA approves BMS chemotherapy drug

The FDA has approved US-based pharmaceutical company Bristol-Myers Squibb's new drug to treat advanced breast cancer, Ixempra

The FDA has approved US-based pharmaceutical company Bristol-Myers Squibb's (BMS) new drug to treat advanced breast cancer, Ixempra (ixabepilone).

Ixempra was approved for use in women who have failed treatment on three other types of chemotherapy. The drug was also approved for use with another chemotherapy drug Xeloda (capecitabine) manufactured by Swiss pharmaceutical company Roche for use in women with metastasized breast cancer.

Ixempra was granted priority review status, which reduces the standard 10-month drug review time by four months. The drug is reserved for treatments the FDA believes in advance over existing marketed treatments.

Ixempra inhibits the protein tubulin, which stops cells growing and dividing by arresting the cell cycle. The drug is part of a new class of drugs known as epothilones. The mechanism of action is similar to taxanes, such as sanofi-aventis' Taxotere (docetaxel), but the chemical structure is simpler and they are more soluble in water.

Share in BMS, which were down USD 0.49 at USD 29.24 on 16 October 2007, rose to USD 29.95 in post-market trading.

Chemotherapy is generally administered by an injection or an infusion and kills cancer cells. The treatment also kills healthy cells, however, and has side effects, such as fatigue and peripheral neuropathy.

In clinical studies, half of 752 patients received Xeloda plus Ixempra, while the other half received Xeloda alone. Progression-free survival was 5.8 months among those taking Ixempra plus Xeloda, compared with 4.2 months in the Xeloda-alone group. There was a greater rate of tumour response in the Ixempra group. About 23 per cent of patients in the Ixempra reported neuropathy while no patients receiving Xeloda alone had neuropathy.

BMS is also studying Ixempra for use in treating earlier-stage breast cancer, non-small cell lung, ovarian, prostate, pancreatic and renal cancers.

30th September 2008

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