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.
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.
Vopratelimab/JTX-4014 to be Evaluated in Phase 2 Study for Immunotherapy-Naïve NSCLC
December 17th 2020December 17, 2020 - Jounce Therapeutics will evaluate its lead agent vopratelimab in combination with the anti–PD-1 monoclonal antibody JTX-4014, in patients with non-small cell lung cancer who have not received immunotherapy.
Liso-Cel Proves to Be Highly Active, Tolerable in Relapsed/Refractory MCL
December 17th 2020December 17, 2020 - Lisocabtagene maraleucel exhibited promising antitumor activity with low rates of grade 3 or higher cytokine release syndrome and neurotoxicity in patients with relapsed/refractory mantle cell lymphoma.
Overcoming CDK4/6 Inhibitor Resistance in ESR1-Mutant HR+/HER2- Breast Cancer
December 17th 2020Massimo Cristofanilli, MD, highlights the introduction of CDK4/6 inhibitors, such as abemaciclib, ribociclib, and palbociclib, which has been a significant addition to the hormone receptor–positive, HER2-negative breast cancer armamentarium.
AR Inhibitors Lead to Higher Fall/Fracture Risk in Older Men With Prostate Cancer
December 17th 2020December 17, 2020 - Androgen receptor inhibitor–therapy is associated with an increased risk of falls and fractures in patients with prostate cancer. However, since it has shown improvement in overall survival, the benefits may outweigh the risk.
KTE-X19 Approved in Europe for Relapsed/Refractory MCL
December 17th 2020December 17, 2020 — The European Commission has granted a conditional marketing authorization to the CD19-targeted CAR T-cell therapy KTE-X19 for use in adult patients with relapsed or refractory mantle cell lymphoma who had previously received 2 or more lines of systemic therapy including a BTK inhibitor.
FDA Approval Sought for Sotorasib for KRAS G12C–Mutated Advanced or Metastatic NSCLC
December 17th 2020December 16, 2020 - A new drug application has been submitted to the FDA for sotorasib for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, after at least 1 previous systemic therapy.
FDA Approves Margetuximab-cmkb Plus Chemo in Pretreated Metastatic HER2+ Breast Cancer
December 16th 2020December 16, 2020 - The FDA has approved margetuximab-cmkb plus chemotherapy for use in adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens, at least one of which was for metastatic disease.
Second-Line Motixafortide Plus Pembrolizumab/Chemo Substantially Improves Survival in Stage IV PDAC
December 16th 2020December 16, 2020 - The combination of motixafortide plus pembrolizumab and chemotherapy was found to result in a substantial improvement in overall survival, progression-free survival, and overall response rate when used as a second-line treatment in patients with stage IV pancreatic ductal adenocarcinoma.
Giant of Cancer Care® Eric Winer Elected ASCO President for 2022-2023 Term
December 16th 2020December 16, 2020 - Eric P. Winer, MD, FASCO, 2019 OncLive Giants of Cancer Care® recipient in Breast Cancer, has been elected to serve as the president of ASCO for the 2022-2023 term, and will assume the president-elect position during the 2020 ASCO Annual Meeting.