Alkermes plc today announced that the company’s novel, investigational engineered interleukin-2 (IL-2) variant immunotherapy, nemvaleukin alfa (nemvaleukin), has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of mucosal melanoma. The FDA also designated nemvaleukin as an orphan drug earlier this year to treat MM.

Source: Alkermes plc

Mucosal melanoma arises from melanocytes in a range of internal epithelial tissues of ectodermal origin. The oral cavity, nose and paranasal sinuses, genital tract, and anorectal region are the most familiar primary sites for MM. Mucosal melanoma is a rare disease, accounting for only 0.03% of new cancer diagnoses.

• According to Thelansis disease modeling data, results of literature reviews, surveys, and registry analyses, an estimated 93,760 cases of melanoma were diagnosed in the United States in 2020, ~1.6% of them are on the mucosal surfaces of the body.

However, the current Mucosal Melanoma treatment market share, market uptake, attribute analysis concerning the most potential emerging therapies (CM082 plus JS001, Nemvaleukin Alfa, Ipilimumab and Nivolumab, Imatinib, Sunitinib, MGD013, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, U.K.) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Mucosal Melanoma treatment. The key companies in the advanced development stage are Alkermes, Inc., AnewPharma, Hoffmann-La Roche, Zai Lab (Shanghai) Co., Ltd., Mayo Clinic, etc., targeting MM.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook report on Mucosal Melanoma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

Thelansis specializes in pharmaceutical market research and market Insight Report Company, published reports across the therapeutic area, including rare / ultra-rare and mainstream indication. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making

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