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.

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.

Taletrectinib Under NMPA Review in China for First-Line ROS1+ NSCLC

March 5th 2024

China’s National Medical Products Administration has accepted the second NDA for first-line taletrectinib for ROS1-positive non–small cell lung cancer.

NICE Recommends Dostarlimab Plus Chemo in MSI-High/dMMR Endometrial Cancer

March 5th 2024

The National Institute for Health and Care Excellence recommends the approval of dostarlimab plus chemotherapy for advanced/recurrent endometrial cancer.

Zevorcabtagene Autoleucel Wins Approval in China for R/R Multiple Myeloma

March 1st 2024

China’s NMPA has approved zevor-cel for the treatment of adult patients with relapsed/refractory multiple myeloma after at least 3 lines of therapy.

HIPEC Elicits Similar Complication Rates, PFS in FIGO Stage III and IV Ovarian Cancer

March 1st 2024

HIPEC was not associated with additional complications or worse survival in patients with FIGO stage IV ovarian cancer vs those with stage III disease.

Retrospective Study Suggests Large Proportion of EU-Approved Oncology Drugs Offer Minimal or No Added Benefit

February 29th 2024

Most oncology drugs approved by the EMA recover research and development costs within a few years, even if the drug is providing little added benefit.

EMA Validates Marketing Authorization Application for Nirogacestat in Desmoid Tumors

February 29th 2024

The European Medicines Agency has validated a marketing authorization application seeking the approval of nirogacestat for patients with desmoid tumors.

Tislelizumab Receives CHMP Recommendation for First- and Second-Line Treatment of NSCLC

February 26th 2024

The European Medicines Agency’s CHMP has recommended the approval of tislelizumab in the first- and second-line for non–small cell lung cancer.

Perioperative Pembrolizumab Regimen Receives Positive CHMP Opinion in NSCLC

February 23rd 2024

Pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab has been recommended for approval in high-risk NSCLC by the EMA's CHMP.

Swissmedic Accepts Marketing Authorization Application for Piflufolastat (18F) for Prostate Cancer

February 22nd 2024

Swissmedic has accepted for review a marketing authorization application seeking the approval of Piflufolastat (18F) for prostate cancer.

FDA and EMA Accept Regulatory Submissions for Vorasidenib for IDH-Mutant Diffuse Glioma

February 20th 2024

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

RATIONALE-315 Data Support Perioperative Tislelizumab Plus Chemo in Resectable NSCLC

February 20th 2024

Neoadjuvant tislelizumab plus platinum-based doublet chemotherapy followed by surgery and adjuvant tislelizumab demonstrated efficacy in resectable non–small cell lung cancer.

UV1 Receives Orphan Drug Designation From EMA in Mesothelioma

February 19th 2024

The European Medicines Agency has granted orphan drug designation to UV1 in patients with mesothelioma.

European Approval Sought for Frontline Amivantamab Plus Lazertinib in EGFR+ NSCLC

February 9th 2024

The EMA is evaluating a Type II extension of indication application for the approval of first-line amivantamab plus lazertinib in EGFR-mutated NSCLC.