New Indication Sought for Bicalutamide

AstraZeneca recently filed a supplemental new drug application with the US Food and Drug Administration (FDA) for a new indication for its oral hormonal medication bicalutamide (Casodex). The supplemental application asks the FDA to approve the use of bicalutamide (150 mg) monotherapy for the management of patients with locally advanced, nonmetastatic (stage T3-T4, NX, M0) prostate cancer.

This new indication may offer men with prostate cancer an alternative to the currently available options of surgical or medical castration, which are associated with significant quality-of-life issues, including loss of sexual interest and physical capacity. If approved, bicalutamide (150 mg) may allow for intervention at an earlier stage in the disease than is currently approved for bicalutamide (50 mg).

Bicalutamide is a nonsteroidal antiandrogen that works by blocking the action of androgens, such as testosterone, at the cellular level. Bicalutamide (50 mg) has been proven safe and effective for use in combination with a luteinizing hormone–releasing hormone analog in the treatment of metastatic prostate cancer.

“In the United States, a man is diagnosed with prostate cancer every 3 minutes. This potential new indication for Casodex will strengthen the profile of a medicine already proven to be a valuable treatment option for patients with advanced prostate cancer,” said George Blackledge, md, vice president/medical director of oncology, AstraZeneca.

Survival Comparable to Castration, But Quality of Life Is Better

Based on data from two multicenter, randomized clinical trials submitted to the FDA for review, bicalutamide (150 mg) is the first antiandrogen to demonstrate no significant survival difference compared to castration in patients with locally advanced, nonmetastatic prostate cancer. Quality-of-life data for bicalutamide (150 mg) suggest significant improvements in the maintenance of sexual interest and in physical capacity when compared with patients who had undergone castration.

The principal adverse events seen with bicalutamide (150 mg) monotherapy were related to the pharmacologic actions of antiandrogens, mainly gynecomastia and male breast pain. The incidence of these events was higher than that previously observed during combination therapy.

Ongoing Trial in Early-Stage Disease

Bicalutamide (150 mg) is also being studied for use in early-stage prostate cancer in a large, ongoing international trial—the Early Prostate Cancer (EPC) Program. Since 1995, a total of 8,113 patients have been recruited for this trial. The EPC trial is investigating the efficacy and safety of bicalutamide (150 mg) in nonmetastatic prostate cancer as an adjuvant to surgery or radiation therapy or as immediate therapy for men who elect a strategy of “watchful waiting.”