EP. 1: FDA Accepts BLA for Subcutaneous Nivolumab Across Various Solid Tumors
The FDA is considering a subcutaneous nivolumab formulation for various solid tumors based on promising data from the phase 3 CheckMate -67T trial. A target action date has been set for February 28, 2025.
EP. 2: FDA Clears IND for EIS-12656, a Novel Therapy for Multiple Solid Tumors
A clinical trial to evaluate EIS-12656 in patients with specific types of advanced solid tumors will begin following the clearance of an investigational new drug application from the FDA.
EP. 3: FDA to Consider Zenocutuzumab in NRG1+ NSCLC and Pancreatic Cancer
If approved, zenocutuzumab would be the first targeted therapy for neuregulin 1 fusion-positive lung and pancreatic cancers.
EP. 4: FDA Oks ColoSense, a Stool Test for Early Colorectal Cancer Detection
The FDA has approved ColoSense, a stool screening test with 93% accuracy for colon cancer in average-risk adults over the age of 45. This noninvasive option may boost early detection rates.
EP. 5: FDA Clears IND of BTX-9341 in HR+/HER2- Breast Cancer
With the clearance of an investigational new drug application for BTX-9341 from the FDA, a phase 1 trial will evaluate the agent in HR-positive/HER2-negative breast cancer.
EP. 6: 9MW2821 Gains FDA Orphan Drug Designation in Esophageal Cancer
9MW2821 was granted an orphan drug designation from the FDA and is being evaluated for the potential treatment of esophageal cancer, as well as other cancers.
EP. 7: FDA Approves IND of Epstein-Barr mRNA Cancer Vaccine WGc-043
If approved, this would mark the first Epstein-Barr virus-related mRNA therapeutic cancer vaccine.
EP. 8: FDA Grants Fast Track Designation to SNB-101 in SCLC
SNB-101, a nanoparticle drug for small cell lung cancer, received a fast track designation from the FDA for expedited development and review.
EP. 9: FDA Clears IND Application for SynKIR-310 Trial in R/R B-NHL
With the FDA clearance of an investigational new drug application for SynKIR-310, a phase 1 trial evaluating the agent in relapsed/refractory B-cell non-Hodgkin lymphomas will begin.
EP. 10: FDA Greenlights HPV Self-Collection Solution for Cervical Cancer Screening
The FDA has approved one of the first human papillomavirus self-collection solutions for use in the US.
EP. 11: NVL-655 Earns FDA Breakthrough Therapy Designation in ALK-Positive NSCLC
The FDA has given the novel agent NVL-655 a breakthrough therapy designation for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer.
