Duvelisib Indication in Relapsed/Refractory Follicular Lymphoma Withdrawn in U.S. Market
December 6th 2021A United States indication for duvelisib in previously treated relapsed/refractory follicular lymphoma has been voluntarily withdrawn by developer Secura Bio following an assessment of the drug and subsequent consultation with the FDA.
FDA Approves Rituximab Plus Chemo for Select Pediatric Hematologic Malignancies
December 3rd 2021The FDA has approved rituximab plus chemotherapy for previously untreated pediatric CD20-postive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, and mature B-cell acute leukemia following results from the phase 3 Inter-B-NHL Ritux 2010 study.
DNA Sequencing of Bone Marrow Is Predictive of ALL Relapse Following Treatment With Tisagenlecleucel
December 2nd 2021DNA sequencing to detect minimal residual disease and eventual relapse was more accurate than flow cytometry for adult and pediatric patients with acute lymphoblastic leukemia who have been treated with tisagenlecleucel.
Oncology Peer Review On-The-Go: Treatment Options for Relapsed/Refractory Small Cell Lung Cancer
December 2nd 2021Wade Iams, MD, broke down some of the different treatment options, including lurbinectedin and topotecan, for patients with relapsed/refractory small cell lung cancer in the second episode of a 4-part small cell lung cancer podcast series.
FDA Extends Review Period for Pacritinib in Myelofibrosis With Severe Thrombocytopenia
December 1st 2021The FDA has requested more time to review data from 3 pivotal trials featuring pacritinib for the treatment of intermediate or high-risk primary or secondary myelofibrosis with severe thrombocytopenia, thus extending the review period for the agent’s new drug application.
Gemtuzumab Ozogamicin Plus Chemo Improves Outcomes in Pediatric KMT2A-Rearranged AML
December 1st 2021Pediatric patients with KMT2A-rearranged acute myeloid leukemia who were treated with gemtuzumab ozogamicin plus standard chemotherapy experienced improved event-free survival and a reduced relapsed risk.
FDA Grants Olaparib Priority Review in BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer
November 30th 2021Olaparib, which was granted priority review by the FDA, has been shown to improve invasive disease-free survival for patients with BRCA-mutated HER2-negative high-risk early breast cancer.