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.
Pegcetacoplan Improves Efficacy in Complement Inhibitor–Naïve Paroxysmal Nocturnal Hemoglobinuria
April 9th 2022Pegcetacoplan treatment was associated with hemoglobin stabilization and normalization, as well as a superior change from baseline in hemoglobin levels, which showed a meaningful correction of anemia, in patients with complement inhibitor–naïve paroxysmal nocturnal hemoglobinuria.
Pembrolizumab Maintains Survival Benefits in 4-year Follow-Up of KEYNOTE-042 in NSCLC in China
April 8th 2022First-line pembrolizumab monotherapy continued to elicit an overall survival benefit and durable tumor response vs standard-of-care platinum-based chemotherapy in Chinese patients with untreated PD-L1–positive, advanced or metastatic non–small cell lung cancer without sensitizing EGFR or ALK mutations.
Hurvitz Highlights Practice-Changing DESTINY-Breast03 Data in HER2+ Metastatic Breast Cancer
April 8th 2022Sara A. Hurvitz, MD, medical oncologist and medical director at the Jonsson Comprehensive Cancer Center Clinical Research Unit, discussed pivotal findings in the HER2-positive treatment landscape that possess the potential to change practice.
NICE Makes Avelumab Available for Maintenance Treatment of Urothelial Cancer
April 8th 2022Avelumab is now a treatment option for patients with urothelial cancer in the United Kingdom following a recommendation from the National Institute for Health and Care Excellence issued Thursday, April 7, 2022.1
Relmacabtagene Autoleucel Gets Breakthrough Therapy Designation for MCL in China
April 7th 2022The China National Medical Products Administration’s Center for Drug Evaluation has granted a breakthrough therapy designation to relmacabtagene autoleucel for use in the treatment of patients with mantle cell lymphoma.
Study Reveals Increased Disparities in Cervical Cancer Screening Linked With COVID-19 Pandemic
April 7th 2022Women of all races and ethnicities who were referred to a colposcopy clinic for cervical cancer screening following an abnormal Pap smear during the COVID-19 pandemic had a higher likelihood of not adhering to their appointment compared with appointment data collected prior to the pandemic.
Checkpoint Blockade Before Allogeneic Transplant Improves PFS, But Not OS, in Hodgkin Lymphoma
April 7th 2022Checkpoint inhibitors prior to allogeneic hematopoietic cell transplant improved progression-free survival and relapse incidence in patients with Hodgkin lymphoma, but the treatment did not improve non-relapse mortality or overall survival.
RP1/Nivolumab Combo Produces Deep, Durable Responses in Melanoma and Other Skin Cancers
April 6th 2022The combination of the oncolytic vaccine vusolimogene oderparepvec and nivolumab continued to drive encouraging responses with acceptable tolerability in patients with melanoma and other skin cancers.
EMA Accepts Marketing Authorization Applications for Tislelizumab in Select ESCC and NSCLC
April 6th 2022Marketing authorization applications seeking the approval of tislelizumab in patients with advanced or metastatic esophageal squamous cell carcinoma following previous systemic chemotherapy and in select patients with non–small cell lung cancer have been submitted to the European Medicines Agency.
Positive FDA Feedback Supports BLA Submission for Lifileucel in Melanoma
April 6th 2022The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application seeking the approval of lifileucel in the treatment of patients with metastatic melanoma.
Patient Goals and Characteristics Play an Outsized Role in Determining First-Line Treatment for mCRC
April 6th 2022Selecting the optimal frontline treatment regimen for patients with unresectable metastatic colorectal cancer requires careful consideration of multiple patient and treatment characteristics.
Nivolumab/Ipilimumab Approved in Europe for Frontline PD-L1+ Advanced ESCC
April 5th 2022The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.
Lisocabtagene Maraleucel Approved in Europe for Select Relapsed/Refractory LBCL
April 5th 2022The European Commission has granted marketing authorization to the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for use in adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B following 2 or more lines of systemic treatment.