FDA granted fast track qualification for the new immunotherapy nemvaleukin+Keytruda program

Alkermes recently announced that the US Food and Drug Administration (FDA) has granted nemvaleukin alfa (nemvaleukin) fast track designation (FTD), combined with Merck’s anti-PD-1 therapy Keytruda (generic name: pembrolizumab, pembrolizumab) Anti), used to treat platinum-resistant ovarian cancer

Nemvaleukin is a new type of engineered interleukin-2 (IL-2) variant immunotherapy

Fast Track Qualification (FTD) aims to accelerate drug development and rapid review for serious diseases to address serious unmet medical needs in key areas

Structure characteristics and mechanism of nemvaleukin

Nemvaleukin is a new type of engineered fusion protein under research, consisting of a modified interleukin-2 (IL-2) and a high-affinity interleukin-2α receptor chain, designed to selectively bind to medium-affinity IL-2 The receptor complex preferentially expands tumor-killing immune cells while avoiding the activation of immunosuppressive cells

ARTISTRY is a clinical development project sponsored by Alkermes to evaluate nemvaleukin as a potential cancer immunotherapy

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Original source: Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa in Combination With Pembrolizumab for the Treatment of Platinum-Resistant Ovarian Cancer