Bristol Myers Squibb receives FDA approval for Ixempra

Bristol-Myers Squibb (BMS) has received approval for Ixempra by the US Food and Drug Administration (FDA).

The FDA has granted approval for the use of Ixempra (ixabepilone) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer where tumours are resistant or refractory to anthracyclines, taxanes and capecitabine.

Ixempra has been approved when used in combination with capecitabine and BMS has confirmed that it will be available almost immediately.

Linda Vahdat, associate professor of clinical medicine at New York Presbyterian Hospital, highlighted the importance of Ixmpra’s approval, stressing that it presented a viable alternative to patients who have quickly progressed through currently approved chemotherapies.

“Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options,” she illustrated.

The FDA’s decision follows the presentation of two multinational trials which demonstrated the safety and efficacy of Ixempra.

Earlier this month, BMS and ImClone Systems announced that the FDA had approved the updated product labeling for Erbitux (cetuximab).

The product now displays overall survival data when used in the treatment of epidermal growth factor inhibitor (EGFR)-expressing metastatic colorectal cancer (mCRC) patients after failure of both irinotecan and oxaliplatin-based regimens.