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.

Tislelizumab Receives EU Approval in 3 Indications for First- and Second-Line NSCLC

April 23rd 2024

Tislelizumab has been approved in Europe across 3 indications in the first and second line for select patients with non–small cell lung cancer.

Health Canada Green Lights Subcutaneous Atezolizumab for Lung, Breast, and Liver Cancer

April 23rd 2024

Health Canada has approved subcutaneous atezolizumab for use in patients with lung cancer, breast cancer, and hepatocellular carcinoma.

European Commission Approves Cilta-Cel for R/R Myeloma After at Least 1 Prior Line of Therapy

April 22nd 2024

Cilta-cel has received approval from the European Commission for multiple myeloma that is relapsed or refractory to at least 1 prior line of therapy.

First-Line Pembrolizumab Plus Chemo Wins Canadian Approval for HER2– Advanced Gastric/GEJ Adenocarcinoma

April 19th 2024

Health Canada has approved pembrolizumab plus chemotherapy for first-line, locally advanced, unresectable, or metastatic, HER2-negative gastric/GEJ cancer.

EMA Grants Orphan Drug Designation to Annamycin in AML

April 18th 2024

The European Medicines Agency has granted orphan drug designation to annamycin for the treatment of patients with acute myeloid leukemia.

NICE Recommends Tisagenlecleucel for Pediatric R/R B-ALL

April 11th 2024

The National Institute for Health and Care Excellence has recommended the use of tisagenlecleucel in pediatric B-cell acute lymphoblastic leukemia.

Global Cancer Statistics Report Provides Insights into Cancer Incidence and Mortality

April 10th 2024

The Global Cancer Statistics, 2024, report from the American Cancer Society sheds light on worldwide cancer facts, identifying trends and making predictions for the future.

Toripalimab Plus Axitinib Approved in China for Frontline Renal Cell Carcinoma

April 9th 2024

The NMPA of China has approved toripalimab plus axitinib for use in the first-line treatment of patients with medium- to high-risk unresectable or metastatic RCC.

FDA Grants Breakthrough Therapy Designation to First-Line Sunvozertinib for EGFR Exon 20+ NSCLC

April 8th 2024

The FDA has granted breakthrough therapy designation to sunvozertinib for patients with locally advanced or metastatic NSCLC with an EGFR exon 20 insertion mutation.

European Commission Approves Frontline Luspatercept for Transfusion-Dependent Anemia in Lower-Risk MDS

April 3rd 2024

The European Commission has expanded its approval of luspatercept to include frontline treatment of transfusion-dependent anemia due to lower-risk MDS.

NICE Endorses Cabozantinib Plus Nivolumab in Advanced RCC

April 2nd 2024

NICE has recommended the combination of cabozantinib and nivolumab for adult patients with advanced renal cell carcinoma in a final draft guidance.

China’s NMPA Grants Priority Review to Sintilimab Plus Fruquintinib in pMMR/Non–MSI-H Advanced Endometrial Cancer

April 2nd 2024

The new drug application for sintilimab plus fruquintinib has been granted priority review by the NMPA for pMMR/non-MSI-H advanced endometrial cancer.

China’s NMPA Accepts sBLA for Enfortumab Vedotin Plus Pembrolizumab in Advanced Urothelial Cancer

March 28th 2024

China’s NMPA accepted a sBLA for enfortumab vedotin plus pembrolizumab for the first-line treatment of locally advanced or metastatic urothelial cancer.

Observational Study Shows Frontline Ibrutinib With/Without Rituximab Is Safe and Effective in Low-Risk Mantle Cell Lymphoma

March 28th 2024

Ibrutinib with or without rituximab was effective and tolerable in patients with previously untreated, low-risk mantle cell lymphoma.

China’s NMPA Accepts sNDA for Savolitinib in Locally Advanced/Metastatic MET Exon 14+ NSCLC

March 28th 2024

China’s NMPA has accepted an sNDA for approval of savolitinib for treatment-naive locally advanced/metastatic NSCLC with MET exon 14 skipping alterations.

Perioperative Pembrolizumab Wins Approval in Europe for Resectable NSCLC at High Risk of Recurrence

March 28th 2024

The European Commission has approved neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, for high-risk, resectable NSCLC.

Clearer Definitions of Added Benefit, Unmet Needs Could Improve EU Oncologic Drug Approval Process

March 27th 2024

Investigators emphasize the importance of firming a widely understood definition of unmet needs in cancer care due to their impact on drug approvals.

Japan’s MHLW Approves Zolbetuximab in CLDN18.2-Positive Gastric Cancer

March 26th 2024

The Japanese Ministry of Health, Labour and Welfare has approved zolbetuximab for CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer.

Enzalutamide Receives Positive EU CHMP Opinion for High-Risk Biochemically Recurrent nmHSPC

March 22nd 2024

The EMA’s CHMP has recommended the approval of enzalutamide with or without androgen deprivation therapy in biochemically recurrent nmHSPC.

Ide-Cel Receives EU Approval for Triple Class–Exposed R/R Multiple Myeloma

March 21st 2024

The European Commission has approved idecabtagene vicleucel for triple-class–exposed relapsed/refractory multiple myeloma.