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SpringWorks Therapeutics
NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

Shots: The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors Trial met its 1EP with 71% reduction in risk of disease progression & showed…
August 19, 2025

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Merck new
NEWS

Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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Remegen
NEWS

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Shots: Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndrome Trial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conference Telitacicept is a…
August 13, 2025

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NEWS

Merck and Pfizer Report Topline P-III (KEYNOTE-905) Trial Finding on Keytruda + Padcev to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The P-III (KEYNOTE-905/EV-303) trial randomized cisplatin-ineligible MIBC pts to Arm A (3 cycles of Keytruda + surgery with 14 subsequent cycles), Arm B (surgery alone), or Arm C (3 cycles of Keytruda + Padcev before surgery, followed 6 cycles of the combination, then 8 cycles of Keytruda alone) Arms C & B showed improved…
August 12, 2025

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Novartis
NEWS

Novartis Reports Topline P-III (VAYHIT2) Trial Finding on Ianalumab Regimen to Treat Primary Immune Thrombocytopenia (ITP)

Shots: Novartis has reported topline P-III (VAYHIT2) trial data assessing ianalumab (3 or 9mg/kg, QM, IV) + eltrombopag vs PBO + eltrombopag in pts with primary immune thrombocytopenia (ITP) who failed 1L corticosteroid treatment Trial met its 1EP with prolonged time to treatment failure & showed increased sustained platelet count improvement at 6mos. (2EP); data…
August 12, 2025

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NEWS

Junshi Biosciences Reports the NMPA’s sNDA Acceptance of Toripalimab + Disitamab Vedotin for Urothelial Carcinoma

Shots:                                                                                                                                                                  China’s NMPA has accepted sNDA of toripalimab + disitamab vedotin for the treatment of HER2+ locally advanced or metastatic urothelial carcinoma (LA/M UC) sNDA was backed by P-III (RC48-C016) trial assessing toripalimab + disitamab vedotin vs gemcitabine + cisplatin/carboplatin across 74 centres in systemic-treatment-naïve Chinese pts with HER2+ LA/M UC Toripalimab is an anti-PD-1…
August 12, 2025

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