By Melissa Weber

Colorectal Cancer
Avastin: On the Fast Track for First-Line Treatment
Thanks to promising results of a phase III trial adding Avastin™ (bevacizumab) to standard chemotherapy, the drug’s maker Genentech, Inc. recently filed a biological license application (BLA) with the U.S. Food and Drug Administration (FDA) for use of the drug as first-line treatment for metastatic colorectal cancer in combination with chemotherapy.

Submitted under the FDA’s fast-track designation, a program that can expedite the review of an investigational treatment for an unmet medical need, Genentech also requested priority review designation. If granted, the FDA would have to complete their review within six months of the date the BLA was submitted, which means a decision would be made by March 2004.

The phase III trial on which the filing was based involved more than 900 patients. Patients treated with Avastin plus chemotherapy survived approximately five months longer than patients given chemotherapy (Camptosar® [irinotecan], 5-FU [fluorouracil], and leucovorin) alone.

Results of a second study involving Avastin in metastatic colorectal patients are expected by the end of the year.

Breast Cancer
More Ammo for Breast Cancer Survivors
Postmenopausal women with surgically resected breast cancer now have more ammunition in their fight against recurrence. A study published in the Nov. 6 edition of The New England Journal of Medicine found that patients with early-stage hormone receptor-positive breast cancer who took Femara® (letrozole) after initially taking five years of adjuvant Nolvadex® (tamoxifen) experienced a significant reduction in their risk of tumor recurrence.

The trial enrolled 5,187 postmenopausal women worldwide, separating the group in half to receive either Femara or placebo after finishing approximately five years of tamoxifen. After two and a half years of follow-up, breast cancer recurred in 132 women taking placebo compared to only 75 taking Femara. Additionally, a total of 42 women died in the placebo group compared to only 31 in the Femara group. The positive results of the Femara trial have resulted in halting the study so that women taking the placebo can be offered the option of taking Femara.

Currently, tamoxifen and Arimidex® (anastrozole) are the only approved options for preventing recurrence in postmenopausal women with surgically resected hormone receptor-positive tumors. But it was found there was no benefit in taking tamoxifen for more than five years. With the results of this trial, women who have finished five years of adjuvant tamoxifen may possibly be able to receive Femara to further reduce their risk of breast cancer recurrence.

Side effects of Femara include hot flashes and osteoporosis. To learn more about Femara, go to www.femara.com.