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.
Rucaparib Meets rPFS End Point in BRCA/ATM-Mutated mCRPC
October 3rd 2022Single-agent rucaparib significantly improved radiographic progression-free survival vs chemotherapy or second-line androgen deprivation therapy in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer harboring BRCA or ATM mutations.
FDA Approves Futibatinib for FGFR2+ Cholangiocarcinoma
September 30th 2022The FDA has granted an accelerated approval to futibatinib (Lytgobi) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements.
GB2064 Reduces the Level of Bone Marrow Fibrosis in Myelofibrosis
September 30th 2022Treatment with GB2064 monotherapy for at least 6 months led to a reduction in collagen fibrosis of the bone marrow of at least 1 grade in 4 of 5 evaluable patients with myelofibrosis, according to topline findings from a planned intermediate assessment of the phase 2a MYLOX-1 trial.
Rusfertide Leads to Promising Phlebotomy Reduction in Polycythemia Vera
September 30th 2022Treatment with rusfertide generated sustained hematocrit control at levels below 45% in patients with polycythemia vera, leading to a reduced need for repeated phlebotomy and eliminating this need in some patients, according to findings from 2 phase 2 clinical trials.
Patritumab Deruxtecan Looks to Make an Impact in NSCLC Treatment Paradigm with HERTHENA-Lung02
September 30th 2022Investigators have set their sights on confirming the viability of HER3 as a clinically actionable therapeutic target for the treatment of patients with EGFR-mutant advanced non–small cell lung cancer, with the initiation of the phase 3 HERTHENA-Lung02 trial evaluating patritumab deruxtecan.
Ivosidenib/Azacitidine Combo Elicits Survival Benefit Over Placebo in IDH1-Mutated AML
September 29th 2022Ivosidenib plus azacitidine displayed favorable event-free survival, overall survival, and clinical responses compared with placebo plus azacitidine in patients with newly diagnosed, IDH1-mutated acute myeloid leukemia, according to findings from the phase 3 AGILE study.
E-Selectin Upregulation and Chemo Combinations Among Recent Developments in AML
September 29th 2022E-selectin has emerged as a viable target in acute myeloid leukemia, and agents like uproleselan have the potential the increase AML cells’ sensitivity to chemotherapies such as cladribine plus low-dose cytarabine.
FDA Greenlights Companion Diagnostic for Selpercatinib in RET+ NSCLC and Thyroid Cancers
September 29th 2022The FDA has approved the Oncomine Dx Target Test as a companion diagnostic to select patients with RET fusion–positive locally advanced or metastatic non–small cell lung cancer, advanced or metastatic thyroid cancer, and advanced or metastatic medullary thyroid cancer who could be candidates to receive selpercatinib.
FDA Accepts NDA for 18F-rhPSMA-7.3 as Diagnostic Imaging Tool in Prostate Cancer
September 29th 2022The FDA has accepted for review a new drug application for 18F-rhPSMA-7.3, an investigational radiohybrid PSMA-targeted PET imaging agent for diagnostic imaging of prostate cancer, according to an announcement from Blue Earth Diagnostics.
Frontline Aumolertinib Significantly Improves PFS Over Gefitinib in EGFR-Mutated NSCLC
September 29th 2022Aumolertinib significantly prolonged progression-free survival vs gefitinib in treatment-naïve patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations, according to findings from the phase 3 ANEAS trial published in the Journal of Clinical Oncology.
Pedmark Reduces Ototoxicity Risk in Cisplatin-Treated Pediatric Solid Tumors
September 29th 2022Nilay Shah, MD, discusses the importance of the FDA approval of sodium thiosulfate for pediatric patients with solid tumors, the favorable toxicity profile of the agent, and how clinical trial findings may inform future care in this population.
Giredestrant Shows Numerical PFS Benefit Vs Endocrine Monotherapy in ER+ Metastatic Breast Cancer
September 28th 2022Giredestrant provided a numerical, but not statistically significant, improvement in progression-free survival over physician’s choice of endocrine therapy in patients with estrogen receptor–positive, HER2-negative, locally advanced or metastatic breast cancer, according to data from the phase 2 acelERA BC study.
Continuous Chemotherapy Improves TTF But Not OS in ER+/HER2- Advanced Breast Cancer
September 28th 2022Vinorelbine plus cyclophosphamide and capecitabine led to a significant improvement in time to treatment failure compared with paclitaxel alone in patients with estrogen receptor–positive, HER2-negative locally advanced or metastatic breast cancer.
Pafolacianine Detects Microlesions in Folate Receptor–Positive Ovarian Cancer
September 27th 2022Pafolacianine used during ovarian cancer surgery identified additional tumors that were not detected with conventional means and not otherwise planned for resection, according to results from a phase 3 study recently published in the Journal of Clinical Oncology.
Tepotinib/Osimertinib Combo Induces ORR Benefit in EGFR-mutated NSCLC
September 27th 2022Julien Maziéres, MD, PhD, explains the importance of defining a second-line standard of care in the EGFR-mutated non–small cell lung cancer population, highlights the long-term benefits seen with tepotinib plus osimertinib, and previews the next steps that should be taken toward more individualized patient care.
Sunvozertinib Generates Responses in Platinum-Pretreated EGFR Exon 20–Mutated NSCLC
September 27th 2022Sunvozertinib provided beneficial antitumor activity when used as a second- or later-line treatment in patients with non–small cell lung cancer harboring EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy.
Sylvester Game Changer Vehicle Among First in Nation to Offer Mobile Prostate Cancer Screening
September 27th 2022Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine’s Game Changer vehicles, which bring health education and free screenings for many cancer types to South Florida communities in need, are offering prostate-specific antigen screening for prostate cancer.