Celcuity Wins FDA Approval for First-in-Class Breast Cancer Drug Revtorpyk (gedatolisib) on July 15, 2026 Approved Celcuity gedatolisib HER2-negative HR-positive Malignant neoplasm of breast mTORC1/2 inhibitor PI3 K inhibitor PIK3CA gene Revtorpyk United States Food and Drug Administration VIKTORIA-1 trial wild-type +
Roche breast cancer pill cuts post-surgery recurrence risk by 30% in major trial on December 11, 2025 Adjuvant Therapy ER-positive giredestrant HER2-negative hormone receptor-positive Hormone Therapy Malignant neoplasm of breast oral SERD Recurrence Risk Roche (company) +
Roche's Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial on November 18, 2025 Adjuvant Therapy Disease-Free Survival ER-positive giredestrant HER2-negative Malignant neoplasm of breast oral SERD Phase 3 trial recurrence prevention Roche (company) +
Roche Claims Its SERD Is Most Potent After Positive Breast Cancer Data Presented at ESMO 2025 on October 20, 2025 ER-positive giredestrant HER2-negative Malignant neoplasm of breast oral SERD Phase 3 Trial Progression-Free Survival Roche (company) Selective Estrogen Receptor Down Regulator +
Ono's BMS-Partnered Oral Gastric Cancer Drug Meets Primary Endpoint in Phase 2 Trial on October 10, 2025 Advanced phase Bristol-Myers Squibb EP4 antagonist EP4 Antagonist ONO-4578 Episodic HER2-negative Malignant neoplasm of stomach nivolumab Opdivo Pharmacotherapy Phase 2 Progression-Free Survival +
Eli Lilly's Oral SERD Inluriyo Approved by FDA for ESR1-Mutated Breast Cancer on September 26, 2025 Approved Carcinoma breast stage IV Eli Eli Lilly EMBER-3 trial ESR1 gene Estrogen receptor positive HER2-negative Imlunestrant Inluriyo Mutation oral SERD United States Food and Drug Administration +