GAITHERSBURG, Md--Members of the FDA's Oncology Drug Advisory Committee (ODAC) agreed that Immu-nex Corp.'s Novantrone (mitoxan-trone)--in combination with corticosteroids--offers a clinical benefit to patients with hormone-resistant prostate cancer.
However, the panel recommended further evaluation of trial data before the FDA makes a decision. Novantrone was originally approved in 1987 for use in acute myelogenous leukemia.
"Until recently, we have had no effective chemotherapy for advanced prostate cancer," said Ian Tannock, MD, professor of medicine at the University of Toronto, who led the pivotal study of the drug. "Pain is the dominant problem."
At the meeting, the company presented data from two unblinded clinical trials to back up its contention that the drug combination decreases pain, suppresses prostate cancer, and significantly improves quality of life in advanced disease patients.
The pivotal study of the drug's analgesic effects involved 161 patients treated at 11 centers with Novantrone plus pred-nisone or prednisone(Drug information on prednisone) alone. Its primary endpoint called for a reduction of two points on a six-point pain scale with stable analgesic use.
Of 80 patients receiving the combination, 21 (26%) achieved this endpoint, as did 10 (12%) of the 81 patients given prednisone only. Those getting the drug combination had a median time to progression of 168 days, compared with 62 days in the prednisone-only group. PSA was reduced in 27% of patients who received the combination, compared with 5% of patients in the prednisone-only group. There was no significant difference in median survival (339 vs 324 days).
A supportive study involved 119 prostate cancer patients given Novantrone plus hydrocortisone(Drug information on hydrocortisone) and 123 given hydrocortisone alone at 62 centers. This study did not examine the primary endpoint of the first study, but did find a PSA decrease in 14% of patients and a time to progression of 218 days in the Novantrone-hydrocortisone group versus a PSA drop in 5% of patients and a progression time of 122 days for those getting hydrocortisone only.