The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
FDA Updates Ibrutinib Label to Include Long-Term Waldenström Macroglobulinemia Data
December 23rd 2020December 23, 2020 - The FDA has updated the prescribing information for ibrutinib to include safety and efficacy data for the agent in combination with rituximab in the treatment of patients with Waldenström macroglobulinemia.
Idasanutlin Induces Responses in Polycythemia Vera, but GI AEs Lead to Frequent Dose Interruptions
December 22nd 2020December 22, 2020 - Idasanutlin, an investigational MDM2 antagonist that leads to increased p53 activity, led to hematologic responses in about two-thirds of patients with hydroxyurea-resistant polycythemia vera, but was associated with frequent discontinuation.
N-803 Plus BCG Elicits 72% CR in BCG-Unresponsive, High-Grade Non-Muscle Invasive Bladder Cancer
December 22nd 2020December 22, 2020 — Intravesical Bacillus Calmette-Guerin in combination with N-803 was found to induce a complete response rate of 72% in patients with non-muscle invasive bladder cancer in high-risk carcinoma in situ disease, meeting the primary end point of the phase 2/3 QUILT 3.032 trial.
Early MRD Monitoring in Younger Patients With MCL Posttransplant Predicts Outcomes
December 22nd 2020December 22, 2020 - Minimum residual disease negativity in the bone marrow and peripheral blood prior to autologous stem cell transplant predicts better progression-free survival and overall survival in younger patients with mantle cell lymphoma.
Gilteritinib/Azacitidine Fails to Significantly Improve OS in Newly Diagnosed FLT3+ AML
December 21st 2020December 21, 2020 — The addition of gilteritinib to azacitidine failed to significantly improve overall survival vs azacitidine alone in patients with newly diagnosed FLT3-mutated acute myeloid leukemia who were not eligible for intensive induction chemotherapy, failing to meet the primary end point of the LACEWING trial.
BLA Initiated for JZP-458 in Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
December 21st 2020December 21, 2020 - The submission of a biologics license application to the FDA has been initiated for JZP-458 for use as a component of a multiagent chemotherapy regimen in the treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.
ViPOR Regimen Is Safe, Shows Impressive Activity in Relapsed/Refractory DLBCL
December 21st 2020December 21, 2020 — The 5-drug regimen of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide showed a tolerable safety profile and encouraging antitumor activity with complete responses in patients with relapsed/refractory diffuse large B-cell lymphoma.
FDA Approval Sought for Cilta-Cel in Relapsed/Refractory Multiple Myeloma
December 21st 2020December 21, 2020 - A rolling submission of the biologics license application for the BCMA-directed CAR T-cell product ciltacabtagene autoleucel for use in adults with relapsed/refractory multiple myeloma has been initiated to the FDA.
Selinexor Combination Regimens Added to NCCN Guidelines for Multiple Myeloma
December 21st 2020December 21, 2020 - The National Comprehensive Cancer Network has added 3 selinexor combination regimens to its Clinical Practice Guidelines in Oncology for previously treated patients with multiple myeloma.
Manochakian Calls for Repeat Genomic Testing Upon Osimertinib Progression in EGFR+ NSCLC
December 20th 2020Rami Manochakian, MD, discusses the role of osimertinib in patients with EGFR-mutated NSCLC, strategies for treatment following progression on the third-generation TKI, and ongoing research efforts to further improve care.
FDA Approves Adjuvant Osimertinib for EGFR+ NSCLC
December 18th 2020December 18, 2020 - The FDA has approved osimertinib for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA Approves Selinexor Plus Bortezomib/Dexamethasone for Multiple Myeloma Following 1 Prior Therapy
December 18th 2020December 18, 2020 - The FDA has approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 previous therapy.
Updates and Advances in Basal Cell Carcinoma
December 18th 2020Although basal cell carcinoma generally has a good prognosis, improving tolerance to targeted Hedgehog inhibitors and optimizing second-line treatment with immune checkpoint inhibitors are important for the small subset of patients who develop locally advanced or metastatic disease.
FDA Advisory Committee Votes in Favor of COVID-19 Vaccine mRNA-1273
December 17th 2020December 17, 2020 - The FDA’s Vaccines and Related Biological Products Advisory Committee has voted 20-0 with 1 abstention to support the benefit-risk profile associated with the coronavirus disease 2019 vaccine mRNA-1273.
FDA Approves Rituximab Biosimilar for NHL, CLL, GPA, and MPA
December 17th 2020December 17, 2020 - The FDA has approved rituximab-arrx, a biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Dr. Rao on Emerging Treatments in HER2+ Metastatic Breast Cancer
December 17th 2020Ruta D. Rao, MD, associate professor in the Department of Medicine, Division of Hematology at Rush Medical College, as well as the director of the Coleman Foundation Comprehensive Breast Cancer Clinic and medical director of Rush University Cancer Center, discusses emerging treatments for patients with HER2-positive metastatic breast cancer.