Global Oncology | Specialty

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 Accepts Marketing Application for Zolbetuximab in CLDN18.2+ Gastric/GEJ Adenocarcinoma

July 17th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of zolbetuximab for first-line treatment of patients with Claudin18.2-positive, HER2-negative, unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

China’s NMPA Accepts sNDA for Frontline Toripalimab Plus Axitinib in Metastatic RCC

July 12th 2023

China’s National Medical Products Administration has accepted a supplemental new drug application seeking the approval of toripalimab plus for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma

Trastuzumab Deruxtecan Approved in China for HER2-Low Metastatic Breast Cancer

July 12th 2023

China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.

Fixed-Duration Glofitamab Approved in Europe for Relapsed/Refractory DLBCL

July 11th 2023

The European Commission has granted conditional marketing authorization to glofitamab for fixed-duration administration in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following 2 or more lines of systemic treatment.

Equecabtagene Autoleucel Approved in China for Relapsed/Refractory Multiple Myeloma

July 7th 2023

China’s National Medical Products Administration has approved the new drug application for equecabtagene autoleucel for the treatment of adult patients with relapsed or refractory multiple myeloma who previously received 3 or more lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.

European Commission Grants Orphan Drug Designation to Temferon for Glioma

June 30th 2023

The European Commission has granted an orphan drug designation to Temferon for the treatment of patients with glioma, joining glioblastoma multiforme in its designation.

Neoadjuvant Nivolumab/Chemo Wins EU Approval for Resectable PD-L1+ NSCLC

June 29th 2023

The European Commission has approved nivolumab in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable non–small cell lung cancer at high risk of recurrence with tumor cell PD-L1 expression of at least 1%.

Repotrectinib NDA Under NMPA Review for Locally Advanced or Metastatic ROS1+ NSCLC

June 28th 2023

The National Medical Products Administration in China has accepted for review a new drug application seeking the approval of repotrectinib for use in adult patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer.

Sacituzumab Govitecan Approaches EU Approval for Pretreated HR+ Metastatic Breast Cancer

June 23rd 2023

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion regarding sacituzumab govitecan-hziy monotherapy in select patients with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer.

European Medicines Agency Validates MAA for Fruquintinib in Pretreated mCRC

June 16th 2023

The European Medicines Agency has validated and accepted a marketing authorization application for priority review for fruquintinib for the treatment of adult patients with pretreated metastatic colorectal cancer.

Infigratinib Receives Breakthrough Therapy Designation in China for Gastric Cancer

June 15th 2023

China’s National Medical Products Administration has granted a breakthrough therapy designation to infigratinib for the treatment of patients with gastric cancer.

Las Implicaciones del Estudo VIALE-A de Venetoclax Mas Azacitidina Para Paciente Inelegibles a Quimioterapia Intensiva

June 14th 2023

Nidia Zapata, MD, discusses the role of triplet therapy in the treatment of patients with acute myeloid leukemia.

El Rol de Los Tripletes en el Tratamiento de la Leucemia Aguda Mieloblástica

June 13th 2023

Nidia Zapata, MD, discusses the role of triplet therapy in the treatment of patients with acute myeloid leukemia.

Majority of US Cancer Centers Report Shortages of Cisplatin/Carboplatin Chemotherapy

June 7th 2023

A survey conducted by the National Comprehensive Cancer Network Best Practices Committee found that 93% of United States cancer centers polled in the report are experiencing a shortage of carboplatin, and 70% currently have a shortage of cisplatin.

EMA Committee Recommends Piflufolastat 18F PSMA PET Imaging Agent for Prostate Cancer

June 1st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of piflufolastat 18F, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, for use in prostate cancer detection.

Olverembatinib Recommended for Breakthrough Therapy Designation in China for SDH-Deficient GIST

June 1st 2023

The China National Medical Products Adminstration’s Center for Drug Evaluation has recommended that olverembatinib receive breakthrough therapy designation for the treatment of patients with gastrointestinal stromal tumor that is succinate dehydrogenase deficient.

European Approval Sought for Cilta-cel in Relapsed and Lenalidomide-Refractory Myeloma

May 26th 2023

A Type II variation application seeking the approval of ciltacabtagene autoleucel in adult patients with relapsed and lenalidomide-refractory multiple myeloma has been submitted to the European Medicines Agency.

EMA Recommends Approval of Neoadjuvant Nivolumab/Chemotherapy in Resectable NSCLC

May 26th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.

Quizartinib Garners Approval in Japan for Newly Diagnosed FLT3-ITD+ AML

May 26th 2023

Japan’s Ministry of Health, Labour, and Welfare has approved quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation and as maintenance monotherapy in patients with newly diagnosed acute myeloid leukemia whose tumors harbor FLT3-ITD mutations.

China’s NMPA Accepts sNDA for Toripalimab Plus Chemo in Advanced TNBC

May 23rd 2023

The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.