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ODAC Votes Against Melphalan Flufenamide in R/R Multiple Myeloma
September 22nd 2022Due to the potential detriment in overall survival, its failure to demonstrate a progression-free survival benefit, and the lack of a known appropriate dose, ODAC has voted that melphalan flufenamide is not favorable in relapsed/refractory multiple myeloma.
FDA’s ODAC Votes That Benefits Do Not Outweigh Risks for Poziotinib in HER Exon 20 Ins+ NSCLC
September 22nd 2022Based on the efficacy, toxicity, dose-optimization, and lack of confirmatory data for poziotinib in HER2 exon 20 insertion-positive non–small cell lung cancer, ODAC has voted that the drug has an unfavorable risk/benefit profile.
Phase 1b Expansion Study of PY159 Doses First Patient With Ovarian Cancer
September 21st 2022Enrollment has begun in the phase 1b trial examining PY159 alone and in combination with pembrolizumab in patients with unresectable and/or metastatic solid tumors that are refractory or relapsed to standard of care.
Gender-Specific AI Model Advances Understanding of Glioblastoma Progression and Treatment Response
September 21st 2022Distinguishing on current imaging between disease progression and pseudo progression in patients with glioblastoma is one of the most difficult clinical problems, according to Manmeet Ahluwalia, MD and Pallavi Tiwari, PhD.
T-Cell Redirection Therapy Shows Promise As Salvage Therapy in R/R Multiple Myeloma
September 15th 2022In a retrospective analysis of 115 patients with relapsed/refractory multiple myeloma who progressed after therapy on a bispecific antibody, researchers found that the myeloma patients can be salvaged with sequential T-cell redirection therapy.
Study of DZD9008 Meets Primary End Point of ORR in EGFR Exon20Ins-Positive NSCLC
September 14th 2022Topline data presented at ESMO 2022 showed DZD9008 met its primary end point of objective response rate and had a benign safety profile in non–small cell lung cancer with EGFR exon 20 insertion mutations.
FDA Clears Phase 1/2 Study of ABT-101 in Non–Small Cell Lung Cancer
September 14th 2022The FDA has granted approval for an investigational new drug protocol amendment for ABT-101, a mutant selective tyrosine kinase inhibitor which has shown superior selectivity against HER2 exon 20 mutations in NSCLC in preclinical studies.