BMS breast cancer drug rejected
pharmafile | November 27, 2008 | News story | Sales and Marketing |Â Â BMS, Cancer, breast cancerÂ
Bristol-Myers Squibb's breast cancer drug Ixempra has suffered a setback in the EU over safety concerns.
The Committee for Medicinal Products for Human Use (CHMP) has rejected a marketing application to use it in the treatment of locally advanced or metastatic breast cancer.
FDA approval was granted for this indication, when the tumour is large or has begun to spread within the body, over a year ago, but the EU regulators have taken a different view.
Ixempra (ixapebilone) is available as a powder and a solvent to be made up into a solution for infusion. The drug was to be used when previous treatment with cytotoxic medicines had failed, either in combination with widely-used cancer drug Roche's Xeloda (capecitabine) or on its own.
Ixempra's active substance, ixabepilone, is an epothilone which stops cells modifying the internal skeleton they need to divide and multiply, but it is also expected to have side effects on non-cancer cells.
This is where the main problem lay. The committee said that potential damage to nerve cells – a severe and common side effect in patients taking the medicine – did not outweigh the increase in survival from breast cancer.
BMS has until the first week in December to request that the CHMP look again at the decision.
Ixempras benefits in terms of increasing the time until the cancer got worse and the very small increase in survival did not make a sufficiently convincing case, the CHMP found.
The committee looked at three main Ixempra studies involving women who had been treated with a number of other anti-cancer medicines in the past. The first study looked at Ixempra on its own, but did not compare it with any other treatment, looking at the number of patients whose cancer responded to treatment.
The other two studies compared the effects of capecitabine on its own with Ixempra in combination with capecitabine.
The main measures of effectiveness were the length of time before patients cancer started to get worse and how long patients survived.
Patients currently in clinical trials or compassionate use programmes with Ixempra will not be affected, BMS said.
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