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.
