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.

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the combination of cabozantinib and nivolumab for adult patients with advanced renal cell carcinoma in a final draft guidance.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

Dr Marth on Frontline Lenvatinib Plus Pembrolizumab in Endometrial Cancer

March 19th 2024

Christian Marth, MD, PhD, discusses the LEAP-001 trial of lenvatinib plus pembrolizumab vs chemotherapy in advanced or recurrent endometrial cancer.

Dr Mirza on the Findings From Part 2 of the RUBY Trial in Endometrial Cancer

March 19th 2024

Mansoor Raza Mirza, MD, discusses findings from part 2 of the ENGOT-EN6-NSGO/GOG-3031/RUBY trial in primary advanced or recurrent endometrial cancer.

Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy

March 18th 2024

China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.

Japanese Approval Sought for Datopotamab Deruxtecan in Pretreated HR+/HER2– Advanced Breast Cancer

March 14th 2024

A new drug application seeking the approval of Dato-DXd for pretreated HR-positive, HER2-negative advanced breast cancer has been filed in Japan.

European Medicines Agency Grants Orphan Drug Designation to Tinengotinib for Biliary Tract Cancer

March 11th 2024

Tinengotinib has been awarded orphan drug designation from the European Medicines Agency for use in select patients with biliary tract cancer.

EMA Receives Indication Extension Application for D-VRd in Newly Diagnosed, Transplant-Eligible Multiple Myeloma

March 6th 2024

The EMA has received a type II variation application for an indication extension of D-VRd for the treatment newly diagnosed multiple myeloma.

Randall Details Inaugural Birmingham Orthopedic Oncology Meeting

March 6th 2024

R. Lor Randall, MD, FACS, discusses the top takeaways from the inaugural 2024 Birmingham Orthopedic Oncology Meeting.