FDA Approved

FDA ApprovedNew FDA Approval in Advanced Clear Cell Renal Cell Carcinoma (ccRCC): The Belzutifan and Lenvatinib CombinationThe FDA approved the combination of belzutifan and lenvatinib for adults with advanced kidney cancer with a clear cell component (ccRCC) previously treated with a PD-1 or PD-L1 inhibitor. In the LITESPARK-011 trial, median progression-free survival increased from 10.6 to 14.6 months compared with cabozantinib.September 28, 2026

FDA ApprovedNew FDA Approval in Advanced Cholangiocarcinoma: Lirafugratinib (Lyrfigtu) for Patients With FGFR2 FusionsThe FDA approved lirafugratinib for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement. In the REFOCUS trial, the objective response rate was 46% and the median duration of response was 11.8 months.September 25, 2026

FDA ApprovedNew FDA Approval in Advanced Breast Cancer: Imlunestrant Plus Abemaciclib for Patients With ESR1 MutationsThe FDA approved imlunestrant plus abemaciclib in ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. In the EMBER-3 trial the combination raised median progression-free survival from 5.5 months with imlunestrant alone to 11.1 months; the Guardant360 CDx liquid biopsy test was approved as the companion diagnostic.September 20, 2026

FDA ApprovedNew Development in Advanced ROS1-Positive Lung Cancer: FDA Updates Taletrectinib’s Duration of Response to Approximately 50 MonthsThe FDA approved the Supplemental New Drug Application for taletrectinib in ROS1-positive non-small cell lung cancer. With 51 months of follow-up from the TRUST-I study, a median duration of response of 49.7 months in patients not previously treated with a tyrosine kinase inhibitor was added to the label.September 18, 2026

FDA ApprovedFDA Approves Sevabertinib for First-Line Treatment of Advanced HER2-Mutant Lung CancerThe FDA granted accelerated approval to sevabertinib as first-line treatment for locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 tyrosine kinase domain mutations. In previously untreated patients, the objective response rate was 75%.September 11, 2026

FDA ApprovedFDA Grants Accelerated Approval to a New Treatment in Advanced Breast Cancer: Etcamah (camizestrant)The FDA approved camizestrant with a CDK4/6 inhibitor in HR-positive/HER2-negative advanced breast cancer. It is the first FDA approval based solely on an ESR1 resistance mutation detected in blood before progression is visible on imaging; progression-free survival rose from 9.2 to 16 months.September 5, 2026

FDA ApprovedFDA Approves New Combination Treatments for Advanced HER2-Positive Gastric and Esophageal CancersThe FDA approved the first-line use of zanidatamab and tislelizumab together with chemotherapy in advanced HER2-positive gastric, gastroesophageal junction and esophageal adenocarcinoma. In the HERIZON-GEA-01 trial, median overall survival rose from 19.2 to 26.4 months.September 1, 2026

FDA ApprovedFDA Approves a First-in-Class Targeted Therapy for Metastatic Pancreatic Cancer: DaraxonrasibThe FDA approved daraxonrasib (Rasonque), a first-in-class RAS inhibitor, for metastatic pancreatic adenocarcinoma. The once-daily pill raised median overall survival from 6.7 to 13.2 months.August 26, 2026

FDA ApprovedFDA Approves Retifanlimab for Squamous Cell Carcinoma of the Anal CanalThe FDA approved retifanlimab (Zynyz) for inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC): with carboplatin and paclitaxel in the first line, and as a single agent after platinum-based chemotherapy.August 12, 2026

FDA ApprovedFDA Approves Zidesamtinib for ROS1-Positive Non-Small Cell Lung CancerThe FDA approved zidesamtinib for adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with at least one ROS1 tyrosine kinase inhibitor.July 27, 2026

FDA ApprovedFDA Approves Gedatolisib Combination for Metastatic Breast CancerThe FDA approved the gedatolisib + fulvestrant combination for patients with endocrine-resistant HR+/HER2- metastatic breast cancer.July 17, 2026

FDA ApprovedA New FDA Approval in Triple-Negative Breast Cancer: Datopotamab Deruxtecan (Datroway) Gets the Green Light!The FDA approved datopotamab deruxtecan-dlnk (Datroway) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) not eligible for PD-1/PD-L1 inhibitor therapy.June 23, 2026

FDA ApprovedA Targeted FDA Approval in Prostate Cancer: Green Light for the Capivasertib + Abiraterone Combination!The FDA approved capivasertib (Truqap) in combination with abiraterone and prednisone for PTEN-deficient metastatic (androgen pathway modulation–naïve/–sensitive) prostate cancer, as determined by an FDA-authorized test.June 18, 2026

FDA ApprovedAn Important FDA Approval in Ovarian Cancer: Green Light for the Relacorilant + Nab-Paclitaxel Combination!The FDA approved the glucocorticoid receptor antagonist relacorilant in combination with nab-paclitaxel for previously treated platinum-resistant epithelial ovarian, fallopian tube and primary peritoneal cancer.June 16, 2026

FDA ApprovedA Breakthrough FDA Approval in Kidney Cancer: Green Light for the Belzutifan + Pembrolizumab Combination!The FDA approved the belzutifan + pembrolizumab combination as adjuvant (post-surgery) therapy for clear cell renal cell carcinoma (ccRCC) patients at high risk of recurrence.June 15, 2026