ROCKVILLE, Maryland—The FDA has approved Gemzar (gemcitabine HCl for injection, Lilly) in combination with carboplatin(Drug information on carboplatin) for the treatment of women with advanced ovarian cancer that relapsed at least 6 months after initial therapy. The agency acted on the basis of clinical trial data showing that the drug combination provided a statistically significant increase in progression-free survival, compared with carboplatin alone, a particularly important endpoint for ovarian cancer. Earlier, the agency's Oncology Drugs Advisory Committee had recommened against approval of the combination. The FDA action came after Lilly provided the agency with additional information, the company said.
"Ovarian cancer is marked by one of the highest recurrence rates of all women's cancers, and when it does progress, it is frequently accompanied by significant symptoms that impede daily activities," said Robert Ozols, MD, PhD, of the Fox Chase Cancer Center. "The Gemzar combination can help us aggressively address this recurrent disease with increased clinical efficacy and generally manageable side effects."
Gemzar's latest indication is its fourth. It won initial approval in 1996 as single-agent therapy of advanced pancreatic cancer; it was approved for use in advanced non-small-cell lung cancer in 1998 and metastatic breast cancer in 2004.
The clinical data submitted by Lilly in support of the new indication came from a randomized, phase III trial of 356 ovarian cancer patients who had relapsed 6 months or more after first-line platinum-based therapy. Patients were randomized to receive either Gemzar 1,000 mg/m2 on days 1 and 8 and carboplatin AUC 4 administered after Gemzar on day 1 of a 21-day cycle, or a single-agent carboplatin AUC 5 given on day 1 of each 3-week cycle. Each arm consisted of 178 patients.
Gemzar/carboplatin patients had a significantly longer progression-free survival than those on carboplatin alone (median 8.6 months vs 5.8 months, P = .0038.) Overall survival favored the treatment group with a median of 18.0 months vs 17.3 months for controls, but the difference was not significant (P = .8977).
