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Top stories in hematology/oncology: CAR T-cell therapy bb2121 shows promising efficacy, FDA grants priority review to darolutamide
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Among the top stories in hematology/oncology last week were a study that found CAR T-cell therapy bb2121 produced high response rates with manageable toxicity in patients with multiple myeloma and the FDA announcement that it will grant priority review to darolutamide, a treatment for nonmetastatic castration-resistant prostate cancer.
Other highlights include expert opinions on the recent CMS announcement that hospital reimbursement will increase by 15% for patients with Medicare receiving inpatient CAR T-cell therapy, the FDA expanded the approval for ivosidenib as a treatment for acute myeloid leukemia and two studies that evaluated how treatment approaches affect outcomes in young women with breast cancer. – by Erin Michael
CAR T-cell therapy bb2121 shows promising efficacy, manageable toxicity in multiple myeloma
A chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen produced high response rates with manageable toxicity among patients with heavily pretreated relapsed or refractory multiple myeloma, according to results of a phase 1 study published in The New England Journal of Medicine. Read more.
FDA grants priority review to darolutamide for prostate cancer subtype
The FDA granted priority review to darolutamide for the treatment of men with nonmetastatic castration-resistant prostate cancer, according to the agent’s manufacturers. Read more.
Medicare’s proposed CAR T reimbursement increase ‘woefully inadequate’
CMS has announced a proposed 15% increase in the amount it would reimburse hospitals for inpatient CAR T-cell therapy for Medicare patients. Read more.
FDA expands approval of Tibsovo for IDH1 -mutant acute myeloid leukemia
The FDA expanded the approval of ivosidenib for acute myeloid leukemia. The new indication allows the agent to be used as monotherapy for individuals aged 75 years or older with newly diagnosed AML who have isocitrate dehydrogenase-1 (IDH1) mutations as detected by an FDA-approved test or are ineligible for intensive induction chemotherapy. Read more.
Early treatment of aggressive breast cancer improves outcomes
Young women with breast cancer appeared to have more aggressive disease than women diagnosed at an older age but similar overall outcomes when the recommended treatment is given, according to results of two retrospective studies presented at European Society for Medical Oncology Breast Cancer Congress. Read more.