FDA Approves Bristol-Myers Squibb's Ixempra

Ixempra gained FDA approval as a stand-alone treatment for patients who've failed other chemotherapy and for use with Roche's Xeloda in patients whose cancer has spread.

Ixempra is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones. A treatment course of Ixempra is expected to cost $18,000 to $23,000, and is expected to earn BMS $500 million in annual sales by 2010.

Use for Breast Cancer

This drug is used to treat metastatic or locally advanced breast cancer. Ixempra is prescribed only for patients whose tumors are resistant to, or no longer benefiting from anthracyclines (such as Adriamycin), taxanes (such as Taxol), and capecitabine (Xeloda).

How it Works

Ixempra is part of the antineoplastic agent class of drugs. This drug slows or prevents the growth of a neoplasm, or tumor, by preventing cell division.

IXEMPRA (ixabepilone) is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.

IXEMPRA is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

The FDA has approved a new type of chemotherapy for the treatment of advanced breast cancer. Marketed by Bristol-Myers Squibb, Ixempra (ixabepilone) is the first of a new class of chemotherapeutic agents called epitholones that target a protein called tubulin, which is necessary for cells to grow and multiply (which they do in a out of control way in cancer). As cancers progress or recur after treatment with one type of chemotherapy, doctors typically give another type of drug with a different mechanism of action hoping to attack the cancer in a new way. The approval of Ixempra provides such a new type of treatment, and it is the first new type of chemotherapy to be approved in many years.