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.
EU Panel Recommends Adjuvant Nivolumab for Select Esophageal, GEJ Cancers
June 25th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after previous neoadjuvant chemoradiotherapy.
Tafasitamab/Lenalidomide Recommended for EU Approval for Relapsed/Refractory DLBCL
June 25th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion in favor of granting conditional marketing authorization to the combination of tafasitamab-cxix and lenalidomide, followed by single-agent tafasitamab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.
Cemiplimab Approved in Europe for PD-L1+ NSCLC, Basal Cell Carcinoma
June 25th 2021The European Commission has granted approval to cemiplimab for the treatment of patients with locally advanced or metastatic non–small cell lung cancer whose tumor cells have at least 50% PD-L1 expression and no EGFR, ALK, or ROS1 aberrations and are ineligible for definitive chemoradiation.
Ide-Cel Granted Positive EU Opinion for Relapsed/Refractory Multiple Myeloma
June 25th 2021The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that idecabtagene vicleucel receive conditional marketing authorization for use in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and a CD38-targeted antibody, and have progressed on their last therapy.
FDA Grants Breakthrough Therapy Designation to Adagrasib for KRAS G12C–Mutated NSCLC
June 25th 2021The FDA has granted a breakthrough therapy designation to adagrasib for use as a potential therapeutic option for patients with KRAS G12C–mutated non–small cell lung cancer following previous systemic therapy.
Lauren Hackett, MPA, to Lead Operations at NCI-Designated Albert Einstein Cancer Center
June 25th 2021Albert Einstein Cancer Center, Albert Einstein College of Medicine, and Montefiore Health System announced that Lauren Hackett, MPA, has been appointed the deputy director of administration of AECC and associate vice president of cancer medicine at Montefiore Medicine.
Frontline Sintilimab Plus Chemo Improves OS in Esophageal Squamous Cell Carcinoma
June 25th 2021The addition of sintilimab to chemotherapy significantly improved overall survival over chemotherapy alone when used as a first-line treatment in patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma, meeting the primary end point of the phase 3 ORIENT-15 trial.
ODAC Postpones Decision on Retifanlimab in Advanced Anal Cancer
June 24th 2021In a 13 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee chose to hold off on a decision regarding accelerated approval for retifanlimab for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or are intolerant of platinum-based chemotherapy.
Olaparib Approved in China for BRCA+ Metastatic Castration-Resistant Prostate Cancer
June 24th 2021The Chinese National Medical Products Administration has granted conditional approval to olaparib for use as a monotherapy in the treatment in adult patients with germline or somatic BRCA-mutated, metastatic castration-resistant prostate cancer who have progressed after previous treatment that included a new hormonal agent like abiraterone acetate or enzalutamide.
Frontline Domvanalimab-Based Combos Elicit Encouraging ORRs in PD-L1–High NSCLC
June 24th 2021The anti-TIGIT agent domvanalimab in combination with zimberelimab with or without etrumadenant demonstrated promising objective response rates when given as a first-line treatment in patients with metastatic non–small cell lung cancer who have a PD-L1 expression of 50% or higher.
Sarcoma, the “Forgotten Cancer”: Examining What’s Needed to Improve Care
June 24th 2021Sarcomas, all together, have an incidence of less than 5/100,000 persons per year, according to the Surveillance, Epidemiology, and End Results Program. Compare that with breast cancer, which impacts 129.1/100,000 women per year, or lung cancer, which has an incidence of 53.1/100,000 persons per year
177Lu Lilotomab Satetraxten Shows Early Activity in Transplant-Ineligible, Relapsed/Refractory DLBCL
June 24th 2021The next-generation CD37-directed radioimmunotherapy 177Lu lilotomab satetraxten has showcased early clinical activity with favorable tolerability when used in patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for stem cell transplantation.
Immunotherapy Is on the Rise in Glioblastoma Treatment
June 23rd 2021The University of Texas MD Anderson Cancer Center is pursuing several novel approaches, including viro-immunotherapy and genetically engineered natural killer cells to treat patients with glioblastoma, while also conducting tumor analysis to better comprehend the disease.
Savolitinib Approved in China for METex14+ NSCLC
June 23rd 2021Savolitinib has been granted a conditional approval in China for use in patients with non–small cell lung cancer with MET exon 14 skipping alterations who experienced disease progression after previous systemic therapy or are unable to receive chemotherapy.
Loncastuximab Tesirine Continues to Impress in Relapsed/Refractory DLBCL and MCL
June 23rd 2021Loncastuximab tesirine-lpyl continued to demonstrate promising antitumor activity with an acceptable toxicity profile when used in the treatment of select patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and mantle cell lymphoma.
Early Relapse Confers Worse Prognosis After Transplant, Calling for Novel Options in High-Risk MCL
June 23rd 2021Peter Riedell, MD, discusses the rationale for a study in mantle cell lymphoma, the clinical implications of the findings, and unanswered questions that future research efforts should aim to answer.
FDA Accepts Application for Pedmark in Prevention of Cisplatin-Induced Ototoxicity in Solid Tumors
June 22nd 2021The FDA has accepted for filing the resubmission of the new drug application for a unique formulation of sodium thiosulfate, for the prevention of ototoxicity that is induced by cisplatin chemotherapy in patients between the ages of 1 month and 18 years who have localized, nonmetastatic, solid tumors.