EP. 1: FDA Approves IDE Application for Alpha DaRT in Recurrent Glioblastoma
A pilot study will evaluate Alpha DaRT for the treatment of patients with recurrent glioblastoma.
EP. 2: FDA OKs Phase 3 Study of Linperlisib in Peripheral T-Cell Lymphoma
Following a successful Type B end-of-phase 2 meeting, the FDA has approved the start of a phase 3 trial of linperlisib in peripheral T-cell lymphoma.
EP. 3: Paige PanCancer Detect Earns FDA Designation for Multi-Tissue Cancer Detection
Paige PanCancer Detect has gained FDA breakthrough device designation, a first for AI identifying diverse cancers across tissues.
EP. 4: FDA Advances ALX2004 to Phase 1 Trials in EGFR+ Solid Tumors
The FDA cleared the investigational new drug application for ALX2004, with phase 1 trials expected to begin in mid-2025 for EGFR+ solid tumors.
EP. 5: FDA Receives New Drug Application for Ziftomenib in NPM1-Mutant R/R AML
Ziftomenib’s FDA application for relapsed/refractory NPM1-mutant acute myeloid leukemia is supported by data from the KOMET-001 trial.
EP. 6: FDA Clears IND Application for ST-001 in SCLC
ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.
EP. 7: FDA Approves Nivolumab/Ipilimumab Combo in MSI-H/dMMR mCRC
Based on data from the phase 3 CheckMate-8HW trial, the combination of nivolumab and ipilimumab has been approved by the FDA in metastatic colorectal cancer.
EP. 8: FDA Clears ZEISS INTRABEAM 700 for IORT in Cancer Surgery
The FDA has granted 501(k) clearance to ZEISS INTRABEAM 700, a robotic-assisted platform designed to enhance intraoperative radiation therapy.
EP. 9: FDA Awards Full Approval to Larotrectinib in NTRK+ Solid Tumors
The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.
EP. 10: FDA Greenlights Bevacizumab Biosimilar Across Cancer Types
The FDA has approved bevacizumab-nwgd, a biosimilar to bevacizumab, for intravenous use across multiple cancer types.
EP. 11: FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Following a recent Type D meeting with the FDA, a phase 3 clinical trial design for darovasertib in primary uveal melanoma has been announced.
EP. 12: FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia
A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus Calmette-Guérin in papillary non-muscle invasive bladder cancer.
EP. 13: FDA Grants Novel Therapy RMAT Designation for Dysphagia Following Head and Neck Cancer Treatment
The FDA granted regenerative medicine advanced therapy designation to iltamciocel for patients with oropharyngeal dysphagia following head and neck cancer treatment.
EP. 14: FDA Clears IND Application for CLD-201 in Solid Tumors
The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.
EP. 15: AI Tool Earns FDA Breakthrough Device Designation in Pancreatic Cancer
The DAMO PANDA can accurately detect pancreatic cancer lesions, and FDA breakthrough therapy designation aims to accelerate its development and approval.
EP. 16: Novel CAR T Therapy Earns FDA Breakthrough Status for Incurable Pediatric Brain Tumor
EP. 17: FDA Clears Phase 1 Study of TGW101 for Advanced Solid Tumor Treatment
Phase 1 trial of TGW101 in advanced solid tumors is enrolling to assess safety and pharmacokinetics and define the maximum tolerated dose in up to 50 patients.
EP. 18: FDA Grants Breakthrough Designation for EvoLiver in HCC
EvoLiver, a blood test that detects early-stage liver cancer with high accuracy, has gained breakthrough device designation from the FDA.
EP. 19: FDA Oks Penpulimab for First-Line Non-Keratinizing Nasopharyngeal Carcinoma
The FDA has approved penpulimab with chemotherapy for first-line recurrent/metastatic non-keratinizing nasopharyngeal carcinoma and alone after prior treatment.
EP. 20: FDA Greenlights VS-7375 Study for Tough-to-Treat KRAS G12D Tumors
With the clearance of an investigational new drug application from the FDA, a phase 1/2a study will evaluate VS-7375 in KRAS G12D-mutant solid tumors.
