Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa Combined with Keytruda in Platinum-Resistant Ovarian Cancer
Oct 26, 2021 01:07
CST Updated
01:07
Alkermes
Innovative Drug Developer
MSD
Pharmaceutical R&D and Manufacturer
FDA
U.S. Food and Drug Administration
October 25, 2021 /BioonBIOON/ --Alkermes recently announced that the U.S. Food and Drug Administration (FDA）has been granted Fast Track designation (FTD) for nemvaleukin alfa (nemvaleukin), in combination with MSD's anti-PD-1 therapy Keytruda (generic name: pembrolizumab), for the treatment of platinum-resistant ovarian cancer.
Nemvaleukin is a novel engineered interleukin-2 (IL-2) variant immunotherapy.Previously,FDANemvaleukin Granted for the Treatment of MucosalMelanomaFast Track Designation (FTD) and Orphan Drug Designation (ODD).
Fast Track Designation (FTD) is designed to accelerate the development and expedited review of drugs for serious conditions, in order to address serious unmet medical needs in key therapeutic areas. When an investigational drug receives Fast Track designation, it means that the pharmaceutical company can, during the research and development phase,FDAEnable more frequent interactions, and upon submission of the marketing authorization application, qualify for accelerated approval and priority review if the relevant criteria are met, in addition to being eligible for a rolling review.
Alkermes Chief Medical Officer and Executive Vice President of Research and Development Craig Hopkinson, MD, said: "FDA"The granting of Fast Track designation for the treatment of platinum-resistant ovarian cancer highlights the potential clinical utility of nemvaleukin in combination with Keytruda for this refractory disease, for which there are currently no approved immunotherapies and a continued need for new treatment options. We are pleased to initiate the planned Phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, with the aim of advancing nemvaleukin toward potential registration to help patients with this disease.”
Structural Features and Mechanism of Action of Nemvaleukin (Click image to view larger version)
Nemvaleukin is a novel investigational engineered fusion protein composed of a modified interleukin-2 (IL-2) and a high-affinity interleukin-2 receptor alpha chain. It is designed to selectively bind to the intermediate-affinity IL-2 receptor complex, preferentially expanding tumor-killing immune cells while avoiding the activation of immunosuppressive cells. The selectivity of nemvaleukin is intended to leverage the proven anti-`Tumor`effect, while mitigating certain limitations.
ARTISTRY is a clinical development program sponsored by Alkermes, evaluating nemvaleukin as a potential cancer immunotherapy. The ARTISTRY program comprises multiple# Clinical Trialscomprising the evaluation of intravenous and subcutaneous administration of nemvaleukin, as monotherapy and in combination with the anti-PD-1 therapy Keytruda, for the treatment of patients with advanced solid tumors. Ongoing trials within the ARTISTRY program include: ARTISTRY-1, ARTISTRY-2, ARTISTRY-3, and ARTISTRY-6. (Bioon.com)