fyi, if you haven't seen this re: FDA's accelerated approval of Roche's Xeloda for metastatic breast cancer. Points to note:
- based on pivotal PII data
- 18% response across all patients, 26% response in subset of Taxol-resistant patients
- required to do PIV studies
- less toxic than traditional chemo, but still reasonably toxic
- oral therapy
This is very encouraging for LGND's cancer trials ... given FDA's receptivity to this submission.
FDA Grants Accelerated Approval For Xeloda(TM)
The First Oral Chemotherapy for the Treatment of Patients with Metastatic
Breast Cancer Resistant to Standard Chemotherapies
NUTLEY, N.J., April 30 /PRNewswire/ -- Hoffmann-La Roche Inc. announced today that it has received accelerated approval from the U.S. Food and Drug Administration (FDA) for Xeloda(TM) (capecitabine), making it the first approved oral anticancer drug for patients with metastatic breast cancer whose tumors are resistant to standard chemotherapy with paclitaxel and an anthracycline-containing regimen.
"Xeloda is a significant advance in the treatment of metastatic breast cancer. At last, patients can take an effective pill, in their homes, to treat their cancer," said Linda Vahdat, M.D., Assistant Professor of Medicine and Director of the Autologous Transplant Program for Breast Cancer, Columbia-Presbyterian Medical Center, New York.
In a pivotal Phase II trial, Xeloda was shown to reduce tumor size by more than 50 percent in one out of four (11/43) patients with hard-to-treat tumors.
Roche received an accelerated approval by the FDA in order to make this important treatment available to patients and physicians as soon as possible. As a condition of accelerated approval, ongoing studies are being undertaken to confirm clinical outcomes. Xeloda's Phase II multi-center trial involved 162 patients with metastatic breast cancer. The FDA's decision was based on a subset of 43 patients resistant to paclitaxel and an anthracycline-containing regimen, the response rate was 26.5 percent. The overall results showed that 18.5 percent of patients experienced a reduction in tumor size of more than 50 percent, and a single patient experienced a complete remission.
About 120,000 women in the United States are living with metastatic breast cancer. "Women need to make informed decisions about their anticancer therapies, and consider both the efficacy and side-effect profile of available treatments," said Kristina Pavlou, Director of Patient Education for Y-ME National Breast Cancer Organization. "Xeloda offers metastatic breast cancer patients a safe and effective treatment option, even after other therapies have failed."
Safety Information
Xeloda caused minimal hair loss and limited bone marrow depression. "Patients often associate chemotherapy with hair loss and bone marrow suppression, which can have a serious impact on a person's quality of life," said Thomas Griffin, M.D., Medical Director of Oncology at Roche. "We anticipate that Xeloda will help redefine chemotherapy."
The most frequently reported side effects included diarrhea, nausea, vomiting, stomatitis (sores in the mouth and throat), fatigue, and hand-foot syndrome (palms of the hands or soles of the feet tingle, become numb, painful, swollen, or red). These side effects were generally manageable and reversible after dosage adjustment. However, Xeloda was associated with serious risks such as severe diarrhea (gastrointestinal side effects greater in patients older than 80) and some grade 3 or 4 neutropenia (4%), thrombocytipenia (2%) and decreases in hemoglobin (3%). Xeloda may cause fetal harm when given to a pregnant woman.
About Hoffmann-La Roche Inc.
Hoffmann-La Roche Inc. is a leading research-intensive pharmaceutical company that discovers, develops, manufactures and markets numerous important prescription drugs that improve, prolong and save the lives of patients with serious illnesses. Among the company's areas of therapeutic interest are virology, including HIV and AIDS, infectious diseases, cardiology, neurology, oncology, transplantation, dermatology and obesity.
The company provides a wide range of medications in the United States through its marketing and sales subsidiary, Roche Laboratories Inc. Headquartered in Nutley, N.J., both companies are members of the Basel, Switzerland-based Roche Group, a global leader in health care with principal businesses in pharmaceuticals, diagnostics, vitamins, fragrances and flavors, and orthopedics.
For more information on this new treatment for metastatic breast cancer, please call Y-ME National Breast Cancer Organization at 800-221-2141.
SOURCE Hoffmann-La Roche Inc.
CO: Hoffmann-La Roche Inc.
ST: New Jersey
IN: MTC
SU: PDT
04/30/98 14:18 EDT prnewswire.com |
