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 Schmid on Key Efficacy Findings With Dato-DXd in Metastatic TNBC

October 25th 2023

Peter Schmid, FRCP, MD, PhD, discusses key findings from the phase 1/2 BEGONIA trial in patients with unresectable, metastatic or locally advanced triple-negative breast cancer, highlighting the clinical significance of these findings.

Epcoritamab Receives UK Approval for R/R DLBCL After 2 Prior Lines of Therapy

October 24th 2023

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.

Relugolix Wins Approval in Canada for Advanced Prostate Cancer

October 23rd 2023

Health Canada has approved relugolix for the treatment of men with advanced prostate cancer.

Trastuzumab Deruxtecan Wins EU Approval for HER2-Mutated Advanced NSCLC

October 23rd 2023

The European Commission has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with advanced non–small cell lung cancer whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Amivantamab Plus Chemotherapy Nearly Doubles PFS in EGFR Exon 20–Mutant NSCLC

October 21st 2023

The combination of amivantamab-vmjw (Rybrevant) and chemotherapy produced a median progression-free survival of 11.4 months vs 6.7 months with chemotherapy alone in patients with advanced, EGFR exon 20 insertion–positive non–small cell lung cancer.

Selpercatinib Significantly Improves PFS Vs Chemo With or Without Pembrolizumab in RET+ NSCLC

October 21st 2023

Selpercatinib (Retevmo) showcased superior efficacy, with improved progression-free survival, vs chemotherapy with or without pembrolizumab in the first-line treatment of patients with RET fusion–positive non–small cell lung cancer.

Zanubrutinib Receives NICE Recommendation for Treatment of CLL

October 20th 2023

The United Kingdom’s National Institute for Health and Care Excellence has issued a final draft guidance recommending the approval of zanubrutinib for the treatment of adult patients with untreated, high-risk chronic lymphocytic leukemia harboring a 17p deletion or TP53 mutation.

Brentuximab Vedotin Plus AVD Wins EU Approval for Previously Untreated CD30+ Stage III Hodgkin Lymphoma

October 19th 2023

The European Commission has approved brentuximab vedotin in combination with doxorubicin, vinblastine, and dacarbazine for the treatment of adult patients with previously untreated, CD30-positive, stage III Hodgkin lymphoma.

EU Panel Recommends Rucaparib for Frontline Maintenance in Advanced Ovarian Cancer

October 17th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding the approval of a Type II variation application for rucaparib as a frontline maintenance in patients with advanced ovarian cancer who have responded to first-line, platinum-based chemotherapy, irrespective of BRCA mutational status.

EMA Grants Orphan Drug Designation to LSTA1 for Pancreatic Cancer

October 17th 2023

The European Medicines Agency’s Committee for Orphan Medical Products has granted orphan drug designation to LSTA1 for the treatment of patients with pancreatic cancer.

Neoadjuvant Daromun Elicits RFS Benefit in Locally Advanced, Fully Resectable Melanoma

October 16th 2023

Neoadjuvant treatment with intratumoral daromun led to a statistically significant and clinically meaningful improvement in recurrence-free survival compared with surgery alone in patients with locally advanced, fully resectable melanoma, meeting the primary end point of the phase 3 PIVOTAL trial.

CHMP Recommends Dostarlimab Plus Chemotherapy in dMMR/MSI-H Advanced/Recurrent Endometrial Cancer

October 16th 2023

The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of dostarlimab plus chemotherapy for the treatment of adult patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

European Commission Approves Adjuvant Pembrolizumab for High-Risk NSCLC

October 16th 2023

The European Commission has approved pembrolizumab as adjuvant monotherapy for the treatment of adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

CHMP Recommends First-Line Pembrolizumab Plus Chemotherapy for PD-L1+, HER2– Advanced Gastric/GEJ Adenocarcinoma

October 13th 2023

The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for pembrolizumab plus fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of adult patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Zanubrutinib Plus Obinutuzumab Approaches EU Approval in R/R Follicular Lymphoma

October 13th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib in combination with obinutuzumab for use in adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 lines of systemic treatment.

Dostarlimab Plus Chemo Wins MHRA Approval for dMMR/MSI-H Primary Advanced/Recurrent Endometrial Cancer

October 6th 2023

The Medicines and Healthcare Products Regulatory Agency has authorized the use of dostarlimab in combination with chemotherapy for the treatment of patients with mismatch repair-deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

European Approval Sought for Amivantamab Plus Chemo in EGFR Exon 20 Insertion+ NSCLC

October 6th 2023

A Type II extension of indication application seeking the approval of amivantamab in combination with carboplatin and pemetrexed for the frontline treatment of adult patients with advanced non–small cell lung cancer and activating EGFR exon 20 insertion mutations has been submitted to the European Medicines Agency.

EMA Validates MAA for Imetelstat for Transfusion-Dependent Anemia in Lower-Risk MDS

October 3rd 2023

The European Medicines Agency has validated the marketing authorization application for the use of imetelstat in the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome.

Japanese Approval Sought for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

October 2nd 2023

A new drug application seeking the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer has been submitted to Japan’s Ministry of Health, Labour, and Welfare.

Epcoritamab Wins European and Japanese Approval for Select Types of R/R LBCL

September 25th 2023

Epcoritamab-bysp has been approved by the European Commission and Japan's Ministry of Health, Labour, and Welfare for the treatment of select patients with relapsed/refractory large B-cell lymphoma.