FDA grants ipilimumab priority review

Ipilimumab (Bristol-Myers Squibb) intended to treat patients with stage III or IV metastatic melanoma has been granted priority review by FDA.

Ipilmumab has been used in a clinical trial at 125 US cancer centers and appears promising in prolonging the life of patients with melanoma. The drug was used in a study involving 676 patients with stage III or IV metastatic melanoma who had been previously treated unsuccessfully with other cancer drugs.

The study, published in the New England Journal of Medicine on August 19, shows 23% of the patients given ipilimumab are alive 2 years later, compared with 14% of those who did not receive the drug. Those taking ipilimumab are living a median of about 10 months compared with 6.4 months for those who receive it.

“This is statistically significant but doesn’t move us significantly further down the optimal outcomes curve,” said Randy Vogenberg, PhD, principal at the Institute for Integrated Healthcare in Sharon, Mass., and executive director of the Biologic Access & Finance program at The Jefferson School of Population Health in Philadelphia. “Marginal extended life at unknown cost or quality of life remains problematic. While the science uncovered is promising, there remains a long way to go in being able to offer a real clinical benefit for longer-term improvement or cure.”

Vogenberg told Formulary that for those who want to be reimbursed or those who pay for it, the questions remain around the value from a technical assessment perspective that remains low. “For patients, the decision dilemma continues since you may gain less than 6 months of extended life with an unknown quality of life at probably a very high cost,” he said.