March 2025 Brief

Tislelizumab plus chemotherapy is now FDA-approved for metastatic esophageal squamous cell carcinoma with a tumor PD-L1 expression of 1 or higher.

Two denosumab biosimilars have gained FDA approvals across multiple indications.

The investigational immunotherapy bexmarilimab has been granted orphan drug designation from the FDA for patients with myelodysplastic syndromes.

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.

The FDA granted orphan drug status to rhenium-186 obisbemeda for treating leptomeningeal metastases in lung cancer.

The FDA cleared the investigational new drug application for MRANK-106, a dual WEE1/YES1 kinase inhibitor, targeting advanced solid tumors.

Ken Kato, MD, discussed the FDA approval of tislelizumab for the first-line treatment of esophageal squamous cell carcinoma.

Bexobrutideg, a first-in-class Bruton’s tyrosine kinase degrader, has been granted orphan drug designation from the FDA in Waldenström macroglobulinemia.

A phase 3 trial plans to evaluate Pro-ocular for the treatment of patients with ocular graft-vs-host disease.

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line treatment.

The combination of pembrolizumab, trastuzumab, and chemotherapy is now approved in HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

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.

PEP-010 was granted FDA orphan drug designation for the treatment of pancreatic cancer.

The FDA has cleared EVM14, making it the first mRNA therapeutic cancer vaccine for global clinical trials.

Azercabtagene zapreleucel has been granted fast track designation from the FDA for the treatment of diffuse large B-cell lymphoma.

The FDA approved cabozantinib for previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic and extrapancreatic neuroendocrine tumors.

A phase 3 trial will evaluate IMNN-001, the first immunotherapy to show an overall survival benefit in ovarian cancer.

A phase 2 trial will evaluate leronlimab’s safety and efficacy for the treatment of patients with microsatellite stable metastatic colorectal cancer.

The FDA approved 177Lu PSMA-617 for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer after androgen therapy.

This approval of durvalumab marks the first and only perioperative immunotherapy regimen available in muscle-invasive bladder cancer.

A phase 3 trial plans to further assess neoadjuvant darovasertib for the potential treatment of patients with primary uveal melanoma.

A second phase 1 trial plans to evaluate CER-1236, a novel chimeric antigen receptor therapy, for solid tumors.