EP. 1: FDA Approves Frontline Tislelizumab Plus Chemotherapy in Advanced ESCC
Tislelizumab plus chemotherapy is now FDA-approved for metastatic esophageal squamous cell carcinoma with a tumor PD-L1 expression of 1 or higher.
EP. 2: Two Denosumab Biosimilars Pocket FDA Approval in Multiple Indications
Two denosumab biosimilars have gained FDA approvals across multiple indications.
EP. 3: FDA Grants Bexmarilimab Orphan Drug Designation for MDS
The investigational immunotherapy bexmarilimab has been granted orphan drug designation from the FDA for patients with myelodysplastic syndromes.
EP. 4: FDA OKs Trial of Novel CAR T-Cell Therapy in T-ALL/LBL
The “off-the-shelf” CAR T-cell therapy CTD402 will be evaluated in a phase 1b/2 trial for patients with T-cell acute lymphoblastic leukemia and lymphoma.
EP. 5: FDA Grants Rhenium Obisbemeda Orphan Drug Status for LM in Lung Cancer
The FDA granted orphan drug status to rhenium-186 obisbemeda for treating leptomeningeal metastases in lung cancer.
EP. 6: FDA Clears Phase 1 Trial of MRANK-106 in Advanced Solid Tumors
The FDA cleared the investigational new drug application for MRANK-106, a dual WEE1/YES1 kinase inhibitor, targeting advanced solid tumors.
EP. 7: Kato Breaks Down FDA Approval of Tislelizumab in Esophageal Cancer
Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.
EP. 8: Bexobrutideg Gains FDA Orphan Drug Status in Waldenström Macroglobulinemia
Bexobrutideg, a first-in-class Bruton’s tyrosine kinase degrader, has been granted orphan drug designation from the FDA in Waldenström macroglobulinemia.
EP. 9: FDA Backs Phase 3 Trial of Pro-ocular for Ocular GVHD Treatment
A phase 3 trial plans to evaluate Pro-ocular for the treatment of patients with ocular graft-vs-host disease.
EP. 10: FDA Grants Orphan Drug Designation to HLX22 for Gastric Cancer Treatment
The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line treatment.
EP. 11: FDA Grants Standard Approval to Pembrolizumab Plus Trastuzumab/Chemo for HER2+, PD-L1+ Gastric Cancer
The combination of pembrolizumab, trastuzumab, and chemotherapy is now approved in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.
EP. 12: FDA Updates Decision on ProSense Cryoablation for Early-Stage Breast Cancer
The FDA has extended its review of the ProSense cryoablation system for early-stage breast cancer, with a decision expected after the first quarter of 2025.
EP. 13: FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
PEP-010 was granted FDA orphan drug designation for the treatment of pancreatic cancer.
EP. 14: FDA Clears IND Application for EVM14 Across Cancers
The FDA has cleared EVM14, making it the first mRNA therapeutic cancer vaccine for global clinical trials.
EP. 15: FDA Grants Azer-Cel Fast Track Status in DLBCL
Azercabtagene zapreleucel has been granted fast track designation from the FDA for the treatment of diffuse large B-cell lymphoma.
EP. 16: FDA Approves Cabozantinib for Advanced Neuroendocrine Tumors
The FDA approved cabozantinib for previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extrapancreatic neuroendocrine tumors.
EP. 17: FDA Backs Phase 3 Study of IMNN-001 in Advanced Ovarian Cancer
A phase 3 trial will evaluate IMNN-001, the first immunotherapy to show an overall survival benefit in ovarian cancer.
EP. 18: Leronlimab Gets FDA Nod for Phase 2 Microsatellite-Stable CRC Trial
A phase 2 trial will evaluate leronlimab’s safety and efficacy for the treatment of patients with microsatellite stable metastatic colorectal cancer.
EP. 19: FDA Expands Indication for Lutetium-177 PSMA-617 in PSMA-Positive mCRPC
The FDA approved 177Lu PSMA-617 for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer after androgen therapy.
EP. 20: FDA Grants Approval to Durvalumab in MIBC
This approval of durvalumab marks the first and only perioperative immunotherapy regimen available in muscle-invasive bladder cancer.
EP. 21: FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma
A phase 3 trial plans to further assess neoadjuvant darovasertib for the potential treatment of patients with primary uveal melanoma.
EP. 22: FDA Clears IND Application for CER-1236 in Advanced Solid Tumors
A second phase 1 trial plans to evaluate CER-1236, a novel chimeric antigen receptor therapy, for solid tumors.
