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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.
Updated Eligibility Criterion Warranted in Clinical Trials of Patients With ATC
April 11th 2023In a study performed at MD Anderson Cancer Center, there was no significant overall survival impact in patients with anaplastic thyroid cancer who had prior differentiated thyroid cancer, concomitant differentiated thyroid cancer, and prior non thyroid cancers.
Ide-Cel Shows Clinically Meaningful PFS Improvement in Triple-Class-Exposed RRMM
April 10th 2023The phase 3 Karmma-3 trial of ide-cel in patients with triple-class-exposed relapsed/refractory multiple myeloma generated significantly improved progression-free survival and overall response rates vs standard regimens.