Novartis: Myfortic label update approved; M.D. Anderson posts endometrial trial results

This week's Novartis-linked activity spanned a completed oncology trial with results posted, two FDA label actions on Myfortic, and two newly registered studies not yet recruiting.

• M.D. Anderson Cancer Center, with Novartis and the National Cancer Institute as collaborators, ran a completed Phase II single-arm trial of everolimus, letrozole, and metformin in advanced or recurrent endometrial carcinoma. Up to 64 patients were enrolled in the study, with up to 59 at MD Anderson and up to 5 patients per site at MD Anderson Cooper and Spartanburg Regional Healthcare System and Harris Health System¹, with results first posted July 30, 2026.
• The FDA approved two supplements for Myfortic (mycophenolate sodium delayed-release tablets, NDA050791): SUPPL 43, filed under submission class REMS², and SUPPL 42, filed under submission class Labeling³, both with a submission status date of 2026-07-29 and approval letters dated 2026-07-30.
• Novartis registered "LILAC-TIMI 76" (NCT07739888), described as an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302⁴. The core study itself is listed as a Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study⁴ in high-risk atrial fibrillation patients unsuitable for oral anticoagulation, with the OLE portion not yet recruiting and an estimated enrollment of 2500 participants⁴.
• Novartis also registered an observational post-marketing surveillance study (NCT07737730) to fulfill the Post Marketing Surveillance (PMS) mandate by the Health Authority (HA) to evaluate the safety of secukinumab solution for injection administered subcutaneously in a pre-filled pen in the indicated population under real-world clinical practice conditions⁵ in Indian adults with axial spondyloarthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. The study is not yet recruiting, with an estimated enrollment of 60 participants⁵ and treatment-emergent adverse events as the primary outcome.