Eulexin (flutamide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 1996

Specific Treatments:

prostate cancer

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General Information

Eulexin capsules have been approved for the treatment of locally confined Stage B2-C carcinoma of the prostate in combination with LHRH agonists and radiation therapy. Eulexin is currently marketed in the United States for the treatment of advanced (Stage D2) prostate cancer in combination with LHRH agonists.

Recommended dosage is two Eulexin capsules three times a day.

Clinical Results

The application was based on a study conducted by the Radiation Therapy Oncology Group (RTOG). In the multicenter controlled clinical trial; Eulexin in combination with an LHRH agonist, was administered prior to and during radiation therapy to subjects with prostate cancer at Stage B2 (with ulky primary tumors confined to prostate) and at Stage C (extending beyond the prostate capsule), with or without pelvic noderostate cancer the opportunity to delay the onset of disease recurrence beyond that shown for radiation alone. The RTOG study also showed a statistical trend toward a reduction in the incidence of distant metastases for subjects in the Eulexin plus LHRH agonist arm.

Side Effects

In the RTOG study, treatment with Eulexin and the LHRH agonist did not add substantially to the side effects reported for radiation treatment alone.

Mechanism of Action

Eulexin is one of a class of drugs known as anti-androgens, which act by directly blocking the cancer-promoting activities of androgens, or male sex hormones, of which the principal one is testosterone. Control of metastatic prostate cancer is based on androgen deprivation. Combining Eulexin with an LHRH agonist is intended to achieve maximum androgen blockade, thereby inhibiting cancer growth.