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.
Pembrolizumab Plus Chemo Maintains Survival Benefit in Treatment-Naïve Nonsquamous NSCLC
September 27th 2022Pembrolizumab plus platinum/pemetrexed continued to demonstrate an overall survival and progression-free survival benefit vs platinum/pemetrexed alone in patients with previously untreated, metastatic squamous non–small cell lung cancer.
Immunotherapy and Targeted Therapy Approaches Drive Advances in Biliary Tract Cancer
September 26th 2022Flavio G. Rocha, MD, FACS, FSSO, discusses the types of biliary tract cancer and what has been learned about them, explains the effects of systemic therapy on surgery, and relays remaining questions pertaining to the efficacy of immunotherapy.
Fruquintinib Provides Significant Survival Benefits in Heavily Pretreated mCRC
September 26th 2022Nageshwara Arvind Dasari, MD, discusses the results of the phase 3 FRESCO-2 trial of fruquintinib in patients with refractory metastatic colorectal cancer, the significance of the data for the treatment paradigm, and the potential next steps for examining the agent in this disease.
FDA Grants Fast Track Designation to KIN-2787 for Select Stage IIB to IV Malignant Melanoma
September 26th 2022The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.
Pembrolizumab Plus Chemotherapy Drives Durable PFS, OS Benefit in Squamous NSCLC
September 24th 2022Pembrolizumab plus chemotherapy demonstrated sustained improvements in progression-free survival and overall survival vs placebo plus chemotherapy in patients with treatment-naïve, metastatic squamous non–small cell lung cancer regardless of PD-L1 expression level.
Duvelisib Loses Support for CLL/SLL Indication Following ODAC Meeting
September 23rd 2022In an 8 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the final overall survival data submitted did not demonstrate a strong enough benefit-risk ratio for duvelisib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies.
Rituximab Maintenance Following First-line BR/R-CHOP Offers Significant Real-World Benefits in MCL
September 23rd 2022Maintenance treatment with rituximab following first-line treatment with rituximab plus bendamustine or rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone produced an overall survival benefit in older patients with mantle cell lymphoma.
Narsoplimab Elicits High Response Rate, Improves Organ Function in HSCT-TMA
September 23rd 2022Treatment with narsoplimab denoted high response rates and a significant improvement in laboratory thrombotic microangiopathy markers, translating to favorable overall survival in patients with hematopoietic stem cell transplantation–associated thrombotic microangiopathy.
Pebbles Fagan, Ph.D., MPH, Joins Leadership Team at UAMS Winthrop P. Rockefeller Cancer Institute
September 23rd 2022Pebbles Fagan, Ph.D., MPH, has assumed the role of associate director for Cancer Prevention and Control for the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences.
ODAC Votes Against Poziotinib for HER2 Exon 20 Insertion–Mutated NSCLC
September 22nd 2022In a 9 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the benefits of poziotinib do not outweigh its risks for the treatment of patients with HER2 exon 20 insertion–mutated non–small cell lung cancer.
Dostarlimab Provides Survival Benefits in dMMR Endometrial Cancer and Other Solid Tumors
September 22nd 2022Single-agent dostarlimab showcased durable antitumor activity in patients with mismatch repair–deficient endometrial cancer and other solid tumors, with landmark estimates at various time points underscoring stable progression-free survival benefits in responders.
China Green Lights Olaparib for First-line Maintenance in HRD+ Advanced Ovarian Cancer
September 22nd 2022Olaparib plus bevacizumab was approved in China as a first-line maintenance treatment for homologous recombination deficiency–positive ovarian cancer following a response to platinum-based chemotherapy plus bevacizumab.
FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion+ Solid Tumors
September 21st 2022The FDA has granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion that have progressed on or after previous systemic treatment or who have no satisfactory alternative treatment options.
FDA Grants Regular Approval to Selpercatinib for Locally Advanced or Metastatic RET+ NSCLC
September 21st 2022The FDA has granted a regular approval to selpercatinib (Retevmo) for adult patients with locally advanced or metastatic non–small cell lung cancer harboring a RET gene fusion, as detected by an FDA-approved test.