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FDA Grants Fast Track Designation to Botensilimab/Balstilimab for MSS/dMMR mCRC Treatment
April 18th 2023The combination of botensilimab and balstilimab is moving down the FDA pipeline and may become an approved treatment for non-microsatellite instability-high and deficient mismatch repair metastatic colorectal cancer in the future.
BGB-3245 Demonstrates Efficacy in Solid Tumors With a Mutation in the MAPK Pathway
April 17th 2023Data presented at the 2023 AACR Annual Meeting on treatment with BGB-3245 in advanced or refractory tumors with a mutation in the MAPK pathway support ongoing investigations of BGB-3245 in defined cohorts during the dose-expansion portion of a phase 1a/1b trial.
FDA Approves Omidubicel for Blood Cancers in Need of Transplant
April 17th 2023Omidubicel showed encouraging clinical benefit in a phase 3 study vs standard myeloablative umbilical cord blood in patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. Now, the FDA has approved the agent for this indication.
FDA Considers Pembrolizumab/Chemotherapy for Approval in Advanced Gastric/GEJ Cancer
April 13th 2023KEYNOTE-859 findings are under review by the FDA as the regulatory body considers an approval application for pembrolizumab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
FDA Halts Phase 1 Study MT-0169 Due to Unacceptable Toxicity
April 12th 2023Multiple cases of unacceptable toxicity requiring dose reductions have occurred in a phase 1 study of MT-0169 in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma. The FDA has placed a partial clinical hold on the study
Part A of THIO-101 Trial Shows Positive Topline Safety Data in NSCLC
April 12th 2023Topline data from part A of the THIO-101 trial showed that patients treated with THIO plus cemiplimab had mild toxicities, including grade 1 fatigue and muscle pain, and 1 case of grade 3 nausea among patients with non–small cell lung cancer.
Dosing of QBS72S Begins for the Treatment of Brain Metastases of Breast Cancers
April 11th 2023A phase 2, open-label clinical trial is evaluating treatment with QBS72S in patients with histologically-confirmed breast cancer that has developed brain metastases after a prior cytotoxic chemotherapy regimen.