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.
Approval for Amivantamab Sought in Europe for Metastatic EGFR Exon 20+ NSCLC
January 4th 2021January 4th, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the approval of amivantamab as a treatment for patients with metastatic non–small cell lung cancer that harbors EGFR exon 20 insertion mutations who have experienced disease progression following platinum-based chemotherapy.
EU Approval Sought for Sotorasib in KRAS G12C–Mutated Advanced or Metastatic NSCLC
January 4th 2021January 4, 2021 - A marketing authorization application has been submitted to the European Medicines Agency for the use of sotorasib in patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer.
Phase 2/3 RINGSIDE Trial of AL102 Can Proceed in Desmoid Tumors
January 4th 2021January 4, 2021 — The pivotal phase 2/3 RINGSIDE trial, which is evaluating the potent, selective oral gamma secretase inhibitor AL102, has been permitted to proceed and can potentially be used as a registrational study for adolescent and adult patients with desmoid tumors.
Liso-Cel BLA for Relapsed/Refractory LBCL Remains Under FDA Review
January 4th 2021January 4, 2021 - The biologics license application for the CAR T-cell product lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA, and a decision on the application has not yet been reached.
Hunt for Predictive Biomarkers for T-DM1 in HER2+ Breast Cancer Continues
January 4th 2021Ian E. Krop, MD, PhD, highlights the impact of the pivotal KATHERINE trial on the adjuvant treatment of patients with early-stage HER2-positive breast cancer and other recent advances that are moving the needle forward.
Expert Compares Open vs Robotic Radical Cystectomy Approaches in Muscle Invasive Bladder Cancer
January 2nd 2021Bryon Lee, MD, PhD, discusses recent advances in surgical technique, approach, and perioperative care have made radical cystectomy significantly less morbid for patients with muscle invasive bladder cancer.
Mian Makes Sense of Multidisciplinary Bladder Preservation Approaches
December 31st 2020Omar Mian, MD, PhD, discusses selective bladder preservation in patients with muscle-invasive bladder cancer, biomarkers of response, and the utilization of hypofractionated radiation vs traditional approaches in this population.
Bristol Myers Squibb Withdraws Nivolumab SCLC Indication From US Market
December 30th 2020December 30, 2020 - Bristol Myers Squibb has withdrawn nivolumab from the US market for the treatment of patients with small cell lung cancer who have experienced disease progression after a platinum-based chemotherapy and at least 1 other line of therapy.
Oncolytics Biotech Launches Trial of Pelareorep/Atezolizumab Combo in Difficult-to-Treat GI Cancers
December 30th 2020December 30, 2020 - The phase 1/2 GOBLET trial will investigate the use of pelareorep in combination with atezolizumab in patients with metastatic colorectal and advanced or metastatic pancreatic and anal cancers.
Petrylak Shares Selection Considerations for Available Agents in Hormone-Sensitive Prostate Cancer
December 29th 2020Daniel P. Petrylak, MD, highlights the use of abiraterone acetate, enzalutamide, and apalutamide and how these agents can lead to improvements in overall survival and progression-free survival in patients with hormone-sensitive prostate cancer.
Immunotherapy Combos Take Next Step in Gynecologic Cancers
December 29th 2020R. Wendel Naumann, MD, discusses numerous investigations of PD-1 inhibitors in combination with PARP inhibitors or other targeted agents, as well as chemotherapy, and how it could finally start the next chapter of immunotherapy in gynecologic malignancies.
FDA Grants Priority Review to Frontline Lorlatinib for ALK+ Metastatic NSCLC
December 28th 2020December 28, 2020 - The FDA has granted priority review to a supplemental new drug application for lorlatinib for use as a frontline treatment in patients with ALK-positive metastatic non–small cell lung cancer.