Supplemental NDA for Sacituzumab Tirumotecan (sac-TMT) in Combination with Pembrolizumab in 1L PD-L1+ve NSCLC Accepted for Review by NMPA May 12, 2026
FDA cleared IND for Ph 1/2 study of oral elraglusib in metastatic melanoma, NSCLC, colorectal, and pancreatic cancers May 12, 2026
NICE issues Final Draft Guidance recommending RYBREVANT + chemo during managed access period in 1L NSCLC with EGFR ex20ins mutations in adults May 12, 2026
Protocol Amendment to NANORAY-312 Ph 3 Head and Neck Cancer Study of for JNJ-1900 (NBTXR3) Announced May 12, 2026
FDA Accepts Supplemental NDA for IBTROZI® (taletrectinib) with Updated DoR in Advanced ROS1+ve NSCLC May 12, 2026
FDA Commissioner’s National Priority Voucher for BIZENGRI® (Zenocutuzumab-zbco) in NRG1 Fusion-Positive Cholangiocarcinoma May 12, 2026
Fast Track Designation for DOC1021 (dubodencel) in Unresectable or Metastatic Cutaneous Melanoma May 12, 2026
US FDA Fast Track Designation for Zocilurtatug Pelitecan (Zoci) for Treatment of Extrapulmonary Neuroendocrine Carcinomas (epNECs) May 12, 2026
FDA Expanded Access Authorization for Daraxonrasib in Patients with Previously Treated Metastatic Pancreatic Cancer May 6, 2026
Ph 2/3 Clinical Trial Application submitted to Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer May 6, 2026
US FDA Accepts NDA for Zipalertinib for the Treatment of Locally Advanced or Metastatic NSCLC with EGFR Exon 20 Insertion Mutations May 6, 2026
US FDA RMAT Designation Granted to Orca-Q® for the Treatment of High-Risk Hematologic Malignancies May 6, 2026
FDA ODAC didn’t reach a majority vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR+ve HER2neg breast cancer May 6, 2026
NDA Submission initiated from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence RTOR Program May 6, 2026
