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May 05, 2026
Topline phase 3 VIKTORIA-1 results showed gedatolisib combinations improved progression-free survival versus alpelisib plus fulvestrant in PIK3CA-mutant HR-positive/HER2-negative advanced breast cancer. Celcuity plans a supplemental FDA filing based on the data.
May 02, 2026
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
May 01, 2026
FDA's ODAC voted 6-3 against AstraZeneca's camizestrant for HR+/HER2- metastatic breast cancer, citing uncertain clinical benefit from the SERENA-6 trial design. The FDA raised concerns about the early-switch treatment paradigm and long-term outcomes.
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
Roche's experimental breast cancer pill giredestrant combined with a CDK4/6 inhibitor failed to meet its primary endpoint in a Phase III trial for first-line treatment of ER-positive, HER2-negative advanced breast cancer, marking a setback for the drugmaker's next-generation hormone therapy program.
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.
Feb 24, 2026
MoonLake Immunotherapeutics says FDA feedback indicates sufficient data to support a U.S. BLA for hidradenitis suppurativa without additional efficacy trials, while Relay Therapeutics received FDA Breakthrough Therapy designation for zovegalisib in combination with fulvestrant for PIK3CA-mutant breast cancer.
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 a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.
Feb 20, 2026
The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.
Feb 16, 2026
The global biopharmaceutical industry entered 2026 facing one of the largest waves of patent expirations in its history, with $200-300 billion in yearly sales at risk through 2032 as major drugs lose exclusivity.
