FDA grants fast-track status for drug in certain patients.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Data from an early phase, multi-center clinical trial suggest that GW572016, a reversible inhibitor of two growth factor receptors involved in the proliferation and survival of many solid tumors, in a once-daily oral dose has clinical and biological activity in patients with metastatic breast cancer who have received multiple prior therapies.

Results from the study of GW572016, an investigational drug discovered and being developed by GlaxoSmithKline (NYSE: GSK), were presented on December 6, 2003, at the 26th Annual San Antonio Breast Cancer Symposium.

The presentation came as GlaxoSmithKline announced that GW572016 had received fast-track designation from the U.S. Food and Drug Administration (FDA). The FDA granted the designation for treatment of certain patients with refractory advanced or metastatic breast cancer who have failed previous therapies. GW572016 does not have regulatory approval in any country for use in any indication.

Howard A. Burris III, MD, director of drug development at the Sarah Cannon Cancer Center, Nashville, Tennessee, who presented the study results at San Antonio, said that, "although our results must be confirmed by additional clinical trials, they are encouraging."

"GW572016 appeared to be active in nearly half the women we evaluated, suggesting that by effectively blocking multiple receptor sites, we eventually may be able to help a larger number of patients with advanced stage breast cancer," Burris said. "Furthermore, the fact that this therapy can be delivered in a once-daily oral dose brings us closer to an era in which we will be able to manage cancer as a chronic disease."

The multi-center study enrolled 67 patients with advanced solid tumors that overexpress ErbB1 (also termed as EGFR) and/or ErbB2, including 30 women with advanced breast cancer. The principle objectives of the study were to evaluate tolerability and biological effect, and to establish an effective once-daily oral dosing range. The study subjects consist primarily of patients who have received multiple prior therapies and still experienced disease progression.

GW572016 was tolerated at doses up to 1600 mg per day. Common drug-related adverse events were mild to moderate (Grades 1 and 2) and included diarrhea, rash, nausea, and vomiting. Grade 3 adverse events included diarrhea, rash, esophageal reflux, and abdominal pain.