FDA Grants Priority Review of Ixabepilone Plus Two Other Agents

The US Food and Drug Administration (FDA) has accepted, for filing and priority review, the New Drug Application (NDA) for Bristol-Myers Squibb's investigational compound ixabepilone, an epothilone B analog. The proposed indications for ixabepilone are as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine (Xeloda) and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane. Currently, there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or whose disease is not responding to prior treatment with chemotherapies.

Oral Topotecan for Relapsed Small-Cell Lung Cancer

GlaxoSmithKline announced that its NDA for oral topotecan (Hycamtin) capsules, a treatment for relapsed small-cell lung cancer (SCLC), has also been granted priority review by the FDA. This application was based on encouraging results from a phase III study comparing oral topotecan plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to two phase II and phase III supporting studies. Unlike IV topotecan, which requires 5 consecutive days of intravenous therapy every 3 weeks, oral topotecan will allow patients to be treated at home.

Cetuximab and Overall Survival in Advanced Colorectal Cancer

ImClone Systems and Bristol-Myers Squibb announced that the FDA has granted priority review to a supplemental biologics license application (sBLA) for cetuximab (Erbitux). With this application, the companies seek to include evidence of improved overall survival in the product labeling for cetuximab in the third-line treatment of patients with metastatic colorectal cancer. If the sBLA is approved, cetuximab would be the only biologic therapy to demonstrate improved overall survival as a single agent in patients with metastatic colorectal cancer.