Recommendation for refusal of marketing authorization for ixabepilone
EMEA adopts negative opinion for treatment of metastatic or locally advanced breast cancer
On 20 November 2008, the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion of the marketing authorization for ixabepilone (2 mg/ml powder and solvent for concentrate for solution for infusion) intended to treat locally advanced or metastatic breast cancer, and recommended that it be refused. The company applying for authorization, Bristol-Myers Squibb Pharma EEIG, may request a re-examination within 15 days of receiving notification of this negative opinion.
Ixabepilone was expected to be used either in combination with capecitabine or on its own, and after previous cytotoxic treatment had failed,.
Ixabepilone is a cytotoxic medicine that belongs to epothilones and is expected to block the ability of cells to modify the internal skeleton that they need to divide and multiply. Ixabepilone is also expected to affect non-cancer cells such as nerve cells, which could cause side effects.
Ixabepilone has been examined in three main studies involving women with locally advanced or metastatic breast cancer and who had already been treated with a number of other anticancer medicines.
The first study looked at ixabepilone given on its own to 128 women, but did not compare it with any other treatment. The main measure of effectiveness was the number of patients whose cancer responded to treatment.
The other two studies compared the effects of capecitabine given on its own with the effects of ixabepilone given in combination with capecitabine in a total of 1,973 women. The main measures of effectiveness were time to progression and overall survival.
The CHMP recommended that ixabepilone be refused marketing authorization because it was concerned that ixabepilone’s benefits in terms of increasing time to progression and the very small increase in survival rates did not outweigh concerns over the medicine’s safety. In particular, the Committee was concerned over neuropathy, which was a severe and common side effect in patients taking the medicine.
The company informed the CHMP that there were no consequences for patients currently included in clinical trials or for compassionate-use programs with ixabepilone.
The EMEA review began on 25 October 2007 with an active review time of 203 days.
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