The OncLive® Global Oncology condition center page is a comprehensive resource for clinical news and international expert insights on treatment of patients with cancer. This page features articles focused on ex-US regulatory news, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing global research in oncology care.
EMA Validates MAA for Repotrectinib in ROS1+ NSCLC and NTRK+ Solid Tumors
January 3rd 2024The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.
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Sugemalimab Plus Chemo Receives Approval in China for Esophageal Squamous Cell Carcinoma
January 2nd 2024The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.
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Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma
December 14th 2023Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.
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Axatilimab Elicits Responses With Manageable Safety in Recurrent/Refractory cGVHD
December 11th 2023Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.
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EMA Validates Application for Epcoritamab in Relapsed/Refractory Follicular Lymphoma
November 27th 2023The European Medicines Agency has validated a type II application for the investigational T-cell engaging bispecific antibody epcoritamab-bysp for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy
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Taletrectinib Under NMPA Review in China for Advanced or Metastatic ROS1+ NSCLC
November 22nd 2023The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.
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Rucaparib Receives EC Approval for Advanced Ovarian Cancer
November 20th 2023The European Commission has approved rucaparib as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy.
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Zanubrutinib Plus Obinutuzumab Gets EU Approval for R/R Follicular Lymphoma
November 17th 2023The European Commission has granted marketing authorization to the combination of zanubrutinib and obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of systemic therapy.
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