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 Issues Complete Response Letter for Neoadjuvant Pembrolizumab for High-Risk TNBC
March 29th 2021The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.
Selinexor/Dexamethasone Approved in Europe for Relapsed/Refractory Multiple Myeloma
March 29th 2021The European Commission has granted conditional marketing authorization for selinexor for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have previously received at least 4 therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody, and have experienced progressive disease on their last therapy.
Liso-Cel Approved in Japan for Relapsed/Refractory Large B-Cell Lymphoma
March 29th 2021Japan’s Ministry of Health, Labour and Welfare has approved lisocabtagene maraleucel, a CAR T-cell therapy designed to target CD19, for the treatment of patients with relapsed or refractory large B-cell lymphoma, as well as relapsed/refractory follicular lymphoma.
Adjuvant Nivolumab Takes Step Toward EU Approval in Muscle-Invasive Urothelial Carcinoma
March 29th 2021The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
Dr. Munshi on the FDA Approval of Idecabtagene Vicleucel in Multiple Myeloma
March 29th 2021Nikhil C. Munshi, MD, discusses the FDA approval of idecabtagene vicleucel for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Dr. Ramalingam on Treatment After Osimertinib in EGFR-Mutant NSCLC
March 27th 2021Suresh S. Ramalingam, MD, FASCO, deputy director, director, Lung Cancer Program, Winship Cancer Institute of Emory University, professor, assistant dean, Roberto C. Goizueta Distinguished Chair for Cancer Research, director, Division of Medical Oncology, Department of Hematology and Medical Oncology, Emory University School of Medicine, discusses treatment after osimertinib (Tagrisso) in EGFR-mutant non–small cell lung cancer (NSCLC).
Durvalumab Use Differs in Real-World, PACIFIC Stage III NSCLC Populations
March 27th 2021More patients with stage III non–small cell lung cancer received sequential chemoradiation and delayed the time to durvalumab treatment in a real-world setting compared with those enrolled on the phase 3 PACIFIC trial.
Frontline Osimertinib Showcases Real-World Safety, Efficacy in EGFR+ Advanced NSCLC
March 27th 2021Osimertinib (Tagrisso) showcased encouraging efficacy and acceptable safety in patients with EGFR-positive, advanced non–small cell lung cancer. according to real-world findings from an observational, multicenter study.
Burst of Treatment Options in HCC Complicates Sequencing Decisions
March 27th 2021Options for systemic treatment for patients with hepatocellular carcinoma have significantly expanded since 2017, when the sole available option was sorafenib. Now, the arsenal includes checkpoint inhibitors, targeted therapies, and combinations of both classes of drugs.
FDA Approves Idecabtagene Vicleucel for Relapsed/Refractory Multiple Myeloma
March 27th 2021The FDA has approved idecabtagene vicleucel as the first BCMA-directed CAR T-cell therapy for patients with relapsed/refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
Immunotherapy Begins to Make Its Way Into Early- and Intermediate-Stage HCC
March 26th 2021Although the combination of atezolizumab and bevacizumab has become the standard frontline treatment for patients with advanced hepatocellular carcinoma, whether immunotherapy could play a role in earlier lines of treatment remains the subject of ongoing research.
Chemotherapy Plus Immunotherapy Shows No Benefit Following Osimertinib in EGFR+ NSCLC
March 26th 2021Treatment with chemotherapy plus immunotherapy did not demonstrate significant clinical benefit over chemotherapy alone in patients with EGFR-mutated non–small cell lung cancer after progression on osimertinib.
Prior Immunotherapy or Osimertinib Negatively Impacts Outcomes With Subsequent Atezolizumab in NSCLC
March 26th 2021Previous exposure to immune checkpoint inhibitors or osimertinib has been linked with poor outcomes in patients with non–small cell lung cancer who were receiving a subsequent atezolizumab-containing regimen.
EU Panel Recommends Atezolizumab for Frontline PD-L1–High Metastatic NSCLC
March 26th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.
Sacituzumab Govitecan Application for Metastatic TNBC Fast-Tracked in Europe
March 26th 2021The European Medicines Agency has validated a Marketing Authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who had previously received at least 2 therapies, including at least 1 therapy for locally advanced or metastatic disease.
EMA Accepts Application for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
March 26th 2021The European Medicines Agency has accepted a marketing authorization application for enfortumab vedotin-ejfv for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant or adjuvant, locally advanced or metastatic setting.
Adagrasib Demonstrates Favorable Efficacy, Pharmacokinetic Profile in Advanced KRAS G12C+ NSCLC
March 25th 2021Adagrasib yielded durable responses and broad disease control, in addition to providing extensive predicted coverage throughout the dosing interval, in patients with KRAS G12C–mutant advanced non–small cell lung cancer.
Nivolumab/Ipilimumab Plus Short-Course Chemo Improves OS Regardless of TMB Status in Advanced NSCLC
March 25th 2021The frontline combination of nivolumab and ipilimumab plus 2 cycles of chemotherapy demonstrated an improvement in overall survival vs chemotherapy alone in patients with advanced non–small cell lung cancer regardless of tumor mutational burden status in the tissue or blood.