A US Food and Drug Administration advisory board has recommended GlaxoSmithKline’s Votrient drug for the treatment of sarcoma but rejected a similar drug made by Merck and Ariad Pharmaceuticals.
The Oncologic Drugs Advisory Committee (ODAC) voted 13 to 1 against the use of Merck’s investigational agent Taltorvic (ridaforolimus) as maintenance therapy for patients with metastatic soft-tissue sarcoma or bone sarcoma whose disease has not progressed after at least four cycles of chemotherapy.
The panel felt that no significant different was observed between a group of patients who took the drug during a clinical trial and those that took the placebo, in terms of overall survival, reports the Pharma Times.
Merck vice president for clinical research oncology Eric Rubin reacted to the news on Monday, "Merck remains confident in the potential of the investigational agent ridaforolimus for an indication where patients have limited options.
"We remain committed to bringing forward this promising therapy for patients with metastatic sarcoma, and look forward to further discussions with the FDA regarding this application."
At the time of Merck’s rejection, the oncology committee voted 11 to 2 in favour of GSK‘s Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have received prior chemotherapy.
ODAC reviewed findings from one Phase III clinical study and one Phase II study which showed the drug enabled patients to live a median of 4.6 months, 3.1 months longer than placebo, without their disease progressing.
GSK Oncology senior vice president said, "Treatment options for patients with advanced soft tissue sarcoma are limited; we are therefore pleased that the committee took a favourable view of the clinical data for Votrient. We look forward to continuing the regulatory process."
