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.
New Study Expands Lifesaving Smoking Cessation Efforts to Rural, Underserved Communities
December 23rd 2021MUSC Hollings Cancer Center researchers hope to save lives by expanding the Tobacco Treatment Program, first implemented at MUSC Health in 2014, to rural and underserved communities to improve overall patient health, save patients money and reduce the number of premature deaths.
Zandelisib Elicits High Response Rates in Relapsed/Refractory Follicular Lymphoma
December 23rd 2021Zandelisib demonstrated significant activity and an encouraging preliminary safety profile in patients with relapsed/refractory follicular lymphoma who have received at least 2 prior systemic therapies.
It Is Time to Reexamine Control Arms in Phase 3 Trials
December 23rd 2021Maurie Markman, MD on strategies to appropriately evaluate small but clinically relevant patient subsets for whom traditional phase 3 randomized clinical trials are difficult, if not impossible, to complete in a realistically timely manner.
Bispecific Antibodies Like Zanidatamab Have Promise in Heavily Pretreated HER2+ Breast Cancer
December 23rd 2021Adam M. Brufsky, MD, PhD, FACP, discusses the rationale to evaluate HER2-directed bispecific antibodies in HER2-positive breast cancer, the emergence of zanidatamab as a potential treatment strategy, and the unmet medical need the agent could fill in this disease.
FDA Grants Breakthrough Therapy Designation to Patritumab Deruxtecan for EGFR+ NSCLC
December 23rd 2021The FDA has granted a breakthrough therapy designation to patritumab deruxtecan for the treatment of patients with metastatic or locally advanced EGFR-mutated non–small cell lung cancer with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.
Frontline Nivolumab/Ipilimumab Shows Trend Toward Improved Intracranial PFS in Advanced NSCLC
December 23rd 2021Frontline nivolumab plus ipilimumab showcased improved overall survival over chemotherapy and a trend toward improved intracranial progression-free survival and duration of response in patients with advanced non–small cell lung cancer.
Lipson Sheds Light on the Evolving Role of ctDNA in the Realm of Melanoma
December 23rd 2021Evan J. Lipson, MD, discusses the role of ctDNA in the neoadjuvant, adjuvant, and metastatic settings in the realm of melanoma, remaining questions with this marker, and future directions to optimize its use in this disease.
Enobosarm Generates Overdue Excitement in AR+/ER+ Metastatic Breast Cancer
December 22nd 2021Lee S. Schwartzberg, MD, discusses the culmination of research with androgen-targeted agents in metastatic androgen receptor–positive, estrogen receptor–positive breast cancer and ongoing research that could lead to a paradigm shift in the second-line setting.
Selinexor Approved in China for Relapsed or Refractory Multiple Myeloma
December 22nd 2021The China National Medical Products Administration has granted a conditional marketing approval to selinexor for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received treatment and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Discovery May Lead to Expanded Donor Pool for Stem Cell Transplants for Patients with Cancer
December 22nd 2021Cancer physicians have long disagreed about whether stem cell transplants from donors with an asymptomatic blood condition called clonal hematopoiesis put recipients at risk for subsequent health problems.
EAU Guidelines Endorse Frontline Immunotherapy-Based Combinations in Advanced RCC
December 22nd 2021Positive findings from the phase 3 CLEAR, CheckMate 9ER, CheckMate 214, and KEYNOTE-426 trials have led to the swift adoption of combination immunotherapy as the preferred frontline standard of care for the treatment of patients with advanced clear cell renal cell carcinoma, which has been further enforced by a recommendation from the European Association of Urology RCC Guidelines Panel.
Emerging Data With KO-539 and Other Menin Inhibitors Generate Excitement in AML
December 22nd 2021Naval Daver, MD, discusses he encouraging early data that has been reported with KO-539 and other menin inhibitors in acute myeloid leukemia, data presented with novel KO-539 combinations in this disease, and next steps for research.
Japanese Approval Sought for Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer
December 21st 2021A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare or the use of fam-trastuzumab deruxtecan-nxki as a treatment in select patients with HER2-positive unresectable or recurrent breast cancer.
CIRCULATE-US Study Will Utilize Signatera MRD Test to Inform Treatment Decisions in Resected CRC
December 21st 2021The Signatera personalized minimal residual disease test will be leveraged in the phase 2/3 CIRCULATE-US trial to inform treatment strategies in patients with early-stage colorectal cancer.
Addition of Lenalidomide to Rituximab Maintenance Improves PFS in Elderly Patients With MCL
December 21st 2021The addition of lenalidomide to rituximab maintenance treatment significantly improved progression-free survival compared with rituximab alone following first-line chemoimmunotherapy in patients with mantle cell lymphoma.
FDA Approval Sought for EirGenix Trastuzumab Biosimilar for HER2+ Breast and Gastric Cancers
December 21st 2021A biologics license application has been submitted to the FDA seeking the approval of a proposed biosimilar for trastuzumab, a monoclonal antibody that is utilized in the treatment of patients with HER2-positive breast cancer and metastatic gastric cancers.
Putting the Extremely Rare Cardiac Angiosarcoma in the Spotlight
December 21st 2021Cardiac angiosarcoma is an exceptionally rare cancer that has become national news because of the recent death of acclaimed fashion designer, Virgil Abloh. He was 41 years old when he died in November 2021, following a 2-year battle with the disease, which is an aggressive subtype of soft-tissue sarcoma.
FDA Approval Offers Hope for Prevention of Acute Graft-Versus-Host Disease
December 21st 2021Approval of the drug abatacept opens up bone marrow transplant as an option for many more patients with cancer or blood disorders — especially patients of diverse ethnicities, who have extra difficulty finding a good match
Parsaclisib Elicits Impressive Activity in Relapsed/Refractory MCL
December 20th 2021The potent, highly selective, next-generation PI3Kδ inhibitor parsaclisib demonstrated activity and an acceptable safety profile in patients with Bruton tyrosine kinase inhibitor-naïve relapsed/refractory mantle cell lymphoma.
Current Management Strategies for Desmoid Tumors Are Marked by Less Surgery, More Systemic Options
December 20th 2021Despite their rarity, the management of desmoid tumors has been an area of significant clinical change as the field has shifted away from aggressive surgical interventions to active surveillance and systemic therapies that are less morbid for patients.
FDA Approves TLX591-CDx for Prostate Cancer Imaging
December 20th 2021The FDA has approved the imaging product TLX591-CDx as a radioactive diagnostic agent for PET of prostate-specific membrane antigen positive lesions in patients with prostate cancer who have suspected metastasis who are candidates for initial definitive therapy, and in those with suspected recurrence based on elevated serum prostate-specific antigen level.