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निर्णायकFDA मंज़ूरी

रेप्लिम्यून: उन्नत मेलानोमा में TUDRIQEV + निवोलुमैब को FDA की त्वरित मंज़ूरी

FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) plus nivolumab in unresectable advanced cutaneous melanoma after anti-PD-1 progression. Approval is based on 24.2% ORR and 14.1-month median DOR from the IGNYTE trial; continued approval requires confirmatory Phase 3 IGNYTE-3 data.

मुख्य तथ्य

फाइल किया गया
7 अग॰ 2026, 01:27 am
घटना
FDA मंज़ूरी
दिशा
सकारात्मक
कंपनी
REPLReplimune
संपत्ति
vusolimogene oderparepvec-wtpg
स्रोत
SEC 8-K
विश्वसनीयता
स्रोत सहित
कैलेंडर
सलाहकार समिति · 30 जुल॰ 2026 · मंज़ूर

स्रोत का अंश

EX-99.1 2 tm2622487d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Replimune Announces FDA Accelerated Approval of TUDRIQEV TM in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma After Progression on an anti-PD-1 Based Regimen Broad label to address high unmet need in advanced melanoma Replimune will host conference call on August 6, 2026 at 4:30 p.m. ET. WOBURN, Mass., August 6, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEV TM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of

SEC 8-K

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