second-line treatment

Eli Lilly’s Jaypirca pushes into first-line CLL, but commercial upside may be limited

5 hours ago talkbio0Tagged Bruin-CLL-314, BTK inhibitor, ceiling, Chronic Lymphocytic Leukemia, CLL, eli lilly, expansion, First line treatment, ibrutinib, Imbruvica, Jaypirca, Labels (device), Market, oncology strategy, Pirtobrutinib, Progression-Free Survival, second-line treatment, SLL, traditional approval, United States Food and Drug Administration

Jaypirca; pirtobrutinib; Eli Lilly; chronic lymphocytic leukemia; CLL; small lymphocytic lymphoma; SLL; first-line treatment; second-line treatment; Bruin-CLL-314; Imbruvica; ibrutinib; BTK inhibitor; progression-free survival; FDA traditional approval; label expansion; market ceiling; oncology strategy

Cogent Hits Unprecedented Efficacy in Rare Stomach Cancer, Clearing Path to FDA

4 weeks ago talkbio0Tagged bezuclastinib, Cogent Biosciences, Effectiveness, Frequency of Responses, Gastrointestinal Stromal Tumors, Infrequent, Malignant neoplasm of stomach, Progression-Free Survival, second-line treatment, Submission, United States Food and Drug Administration

Cogent Biosciences; bezuclastinib; unprecedented efficacy; rare stomach cancer; gastrointestinal stromal tumor (GIST); FDA submission; second-line treatment; objective response rate; progression-free survival

FDA Rejects Roche’s Columvi for Earlier-Line Diffuse Large B-Cell Lymphoma

5 months ago talkbio0Tagged Accelerated, Approved, Columvi, Complete, Diffuse Large B-Cell Lymphoma, gemcitabine, genentech, oxaliplatin, Rejection, Response Letter, Roche (company), second, second-line treatment, STARGLO, Third line treatment, United States Food and Drug Administration

FDA rejection; Columvi; Roche; Genentech; diffuse large B-cell lymphoma; DLBCL; STARGLO study; second-line treatment; Complete Response Letter; gemcitabine; oxaliplatin; accelerated approval; third-line therapy