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May 07, 2026
Sensei Biotherapeutics dosed the first patient in a Phase 1b/2 trial of PIKTOR (sapanisertib + serabelisib) in HR+/HER2- advanced breast cancer. The multi-node PI3K/AKT/mTOR inhibitor previously showed a 47% overall response rate in a Phase 1b trial.
Apr 23, 2026
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Apr 02, 2026
The SONIA trial found no overall survival benefit for first-line CDK4/6 inhibitors versus second-line use in advanced HR+/HER2- breast cancer. Median survival was 47.9 vs 48.1 months, though post hoc analysis suggested benefit in premenopausal patients. First-line treatment was associated with more severe adverse events.
Mar 20, 2026
Recent developments in breast cancer treatment include new clinical trials for advanced disease, findings on CDK4/6 inhibitor sequencing, and discovery of genetic markers explaining drug resistance in HER2-positive breast cancer.
Mar 10, 2026
The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.
Mar 06, 2026
Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.
Nov 17, 2025
The FDA has accepted Celcuity's New Drug Application for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, granting Priority Review with a PDUFA goal date of July 17, 2026.
Feb 20, 2026
The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.
