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 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.
Alpelisib Displays Clinical Benefit in Pediatric PIK3CA-Related Overgrowth Spectrum Disease
September 21st 2022Alpelisib decreased the need for surgery and led to improvements in performance status and disease-related signs and symptoms in pediatric patients with PIK3CA-related overgrowth spectrum disease who received treatment with the PI3K inhibitor under compassionate use.
Rusfertide May Eliminate Need for Frequent Phlebotomies in Polycythemia Vera
September 21st 2022Srdan Verstovsek, MD, PhD, discusses the benefits of rusfertide, an agent currently under evaluation in patients with polycythemia vera. In addition, he lays out the distinctions between low-risk and high-risk polycythemia vera and explains the benefits of this drug in both populations.
FDA Approves Pedmark for Prevention of Platinum-Induced Ototoxicity in Pediatric Solid Tumors
September 20th 2022The FDA has approved sodium thiosulfate (Pedmark) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged 1 month and older with localized, nonmetastatic solid tumors.
Frontline Immunotherapy Combos Linked With Higher CR Rates Than Anti-VEGF Therapy in mRCC
September 20th 2022Immunotherapy-based combinations elicited higher complete response rates compared with VEGF-targeted therapy when used as first-line treatment in patients with metastatic renal cell carcinoma.
Frontline Toripalimab Plus Chemotherapy Approved in China for Advanced Nonsquamous NSCLC
September 20th 2022The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.
Enzalutamide Plus ADT Improves rPFS, OS in Metastatic HSPC With Prior ADT
September 20th 2022Enzalutamide plus androgen deprivation therapy elicited significant improvements in radiographic progression-free survival and overall survival vs placebo in patients with metastatic hormone-sensitive prostate cancer.
EphrinB2 Emerges as Targetable Option in Urothelial Carcinoma
September 20th 2022Treatment with soluble EphB4-human serum albumin plus pembrolizumab elicited synergistic activity and an improved overall survival and objective response rate compared with historical data for PD-1/PD-L1 monotherapy in patients with platinum-refractory metastatic urothelial carcinoma.
HRQOL Is Maintained With Nivolumab in Real-World Population of Pretreated mRCC
September 20th 2022Health-related quality of life was maintained following treatment with nivolumab in the second- or third-line settings in patients with previously treated metastatic renal cell carcinoma, according to findings from a real-world retrospective analysis.
Zanubrutinib Approaches European Approval for Marginal Zone Lymphoma
September 19th 2022The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.
FDA Grants Priority Review to Tucatinib/Trastuzumab Combo for Previously Treated HER2+ mCRC
September 19th 2022The FDA has granted a priority review to a supplemental new drug application seeking the approval of tucatinib for use in combination with trastuzumab in adult patients with HER2-positive colorectal cancer who have received at least 1 prior treatment regimen for unresectable or metastatic disease.
Axi-cel Receives Positive Opinion from EU for DLBCL/HGBL
September 19th 2022The European Medicines Agency Committee for Medicinal Products for Human Use has granted a positive opinion for axicabtagene ciloleucel for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma who relapse within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
Relatlimab Plus Nivolumab Approved in Europe for Unresectable or Metastatic Melanoma with PD-L1 <1%
September 17th 2022The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.
Atezolizumab and Bevacizumab TRAEs are Potential Predictors of Favorable Outcomes in HCC
September 16th 2022Patients with hepatocellular carcinoma who developed treatment-related adverse effects associated with atezolizumab plus bevacizumab had improved overall survival and progression-free survival outcomes.