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Jul 2, 2026Weekly roundup

Novartis: Mayzent label update approved; four real-world studies registered or recruiting

FDA approved a Mayzent labeling supplement while Novartis logged new observational and early-phase trials in prostate cancer, CML, and lymphoma.

Novartis had one regulatory action and four clinical trial registry updates this week.

  • FDA approved a labeling supplement for MAYZENT (siponimod), NDA209884 SUPPL 21, with the submission status marked "AP" and a status date of 2026-06-30; updated label and medication guide documents were posted 2026-07-10.
  • A Phase I trial testing low-dose total body irradiation added to standard lymphodepletion before tisagenlecleucel in relapsed or refractory large B-cell lymphoma is "not yet recruiting." The trial tests the safety, side effects, and best dose of total body irradiation in combination with standard of care lymphodepletion with cyclophosphamide and fludarabine before tisagenlecleucel in patients with large B-cell lymphoma that has relapsed or is refractory.1 The study is led by Nathan Denlinger as sponsor, with Novartis as a collaborator, and plans to enroll 18 participants1 in a phase1 design.
  • Two observational studies using Novartis's PRECISION platform in metastatic castration-resistant prostate cancer (mCRPC) are recruiting. One will assess treatment patterns, clinical outcomes, and patient characteristics among adults with mCRPC in the United States real-world clinical practice, using data extracted from the PRECISION data platform2, with an estimated enrollment of 17111 participants2. The other will assess treatment patterns, characteristics, and clinical outcomes among adults with mCRPC who have previously received at least one androgen receptor pathway inhibitor, at least one taxane, and 177Lu-PSMA-617, using the same PRECISION data platform3, with an estimated enrollment of 1067 participants3.
  • An observational study of asciminib in young adults with chronic myeloid leukemia in the Gulf region is "not yet recruiting." The study aims to evaluate the real-world effectiveness and safety of asciminib among young adults with chronic myeloid leukemia across the Gulf region4, with an estimated enrollment of 80 participants4.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.