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.

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.

European Commission Grants Orphan Drug Designation to NXC-201 for AL Amyloidosis

February 8th 2024

NXC-201 has received orphan drug designation from the European Commission for use in patients with amyloid light-chain amyloidosis.

Health Canada Slated to Review New Drug Submission for Momelotinib in Myelofibrosis

February 5th 2024

Health Canada will review the new drug submission seeking the approval of momelotinib in patients with myelofibrosis.

EMA Validates MAA for Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

February 2nd 2024

The MAA seeking the approval of tisotumab vedotin in select patients with recurrent or metastatic cervical cancer has been validated by the EMA.

EMA Accepts Marketing Authorization Application for Linvoseltamab in R/R Multiple Myeloma

February 2nd 2024

The EMA has accepted for review an MAA seeking the approval of linvoseltamab for use in select patients with relapsed/refractory multiple myeloma.

Japanese Approval Sought for Enfortumab Vedotin Plus Pembrolizumab in Urothelial Cancer

February 1st 2024

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

Momelotinib Approved in Europe for Myelofibrosis With Anemia

January 29th 2024

Momelotinib gets market authorization from the European Commission for patients with MPNs and disease-related splenomegaly or moderate to severe anemia.

Idecabtagene Vicleucel Approaches EU Approval in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma

January 26th 2024

The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.

Olverembatinib Added to NCCN Guidelines for CML

January 22nd 2024

Olverembatinib has been added to the NCCN's latest 2024 guidelines for management of chronic myeloid leukemia.

NICE Recommends Talazoparib for Advanced BRCA1/2-Mutant, HER2– Breast Cancer

January 22nd 2024

NICE has recommended talazoparib for the treatment of patients with advanced or metastatic HER2-negative breast cancer with germline BRCA1/2 mutations.

Dr Shitara on the 4-Year Outcomes of the CheckMate 649 Trial in GEJ Adenocarcinoma

January 20th 2024

Kohei Shitara, MD, discusses first-line nivolumab plus chemotherapy vs chemotherapy alone in gastric cancer, GEJ cancer, or esophageal adenocarcinoma.

Dr Lencioni on the Results of the EMERALD-1 Trial in Unresectable HCC

January 19th 2024

Riccardo Lencioni, MD, FSIR, EB, discusses the EMERALD-1 trial of TACE/durvalumab/bevacizumab in patients with unresectable hepatocellular carcinoma.