FDA grants fast track designation to nemvaleukin alfa for ovarian cancer
The FDA granted fast track designation to nemvaleukin alfa as part of combination therapy for treatment of platinum-resistant ovarian cancer, according to the agent’s manufacturer.
The designation applies to use of nemvaleukin alfa (Alkermes) — an investigational, engineered interleukin-2 variant immunotherapy — in combination with the anti-PD-1 antibody pembrolizumab (Keytruda, Merck).
“This fast track designation in platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin [alfa] in combination with pembrolizumab in this difficult-to-treat disease for which there is no approved immunotherapy and there remains significant need for new treatment options,” Craig Hopkinson, MD, chief medical officer and executive vice president of research and development with Alkermes, said in a company-issued press release. “We are excited to initiate our planned ARTISTRY-7 phase 3 trial in platinum-resistant ovarian cancer, as we advance nemvaleukin [alfa] toward potential registration and seek to help patients living with this disease.”
Alkermes’ ARTISTRY clinical development program is evaluating nemvaleukin alfa as monotherapy and in combination with pembrolizumab for patients with advanced solid tumors.
The FDA previously granted fast track and orphan drug designations to nemvaleukin alfa for treatment of mucosal melanoma.