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.

Trastuzumab Deruxtecan Approved in Japan for HER2-Low or -Ultralow Metastatic Breast Cancer

August 26th 2025

Trastuzumab deruxtecan has been approved in Japan for patients with HR+, HER2-low or -ultralow metastatic breast cancer.

Dato-DXd Approved in China for Previously Treated HR+, HER2– Negative Metastatic Breast Cancer

August 25th 2025

Datopotamab deruxtecan is approved in China for hormone receptor–positive, HER2-negative metastatic breast cancer after prior endocrine therapy and chemotherapy.

EMA Grants Orphan Drug Designation to Pegtarazimod for GVHD

August 23rd 2025

Pegtarazimod has received orphan drug designation from the European Medicines Agency for the management of graft-vs-host disease.

Real-World Data Highlight Feasibility of Venetoclax Plus Obinutuzumab In First-Line CLL With Comorbidities

August 22nd 2025

Venetoclax plus obinutuzumab generated safe and efficacious real-world outcomes in first-line CLL with comorbidities.

Darolutamide Wins Canadian Approval for mCSPC

August 22nd 2025

Health Canada has granted marketing authorization to darolutamide for the treatment of adult patients with metastatic castration-sensitive prostate cancer.

Health Canada Approves Glofitamab Plus Chemotherapy for R/R DLBCL

August 22nd 2025

Glofitamab plus GemOx received approval in Canada for patients with relapsed or refractory DLBCL not otherwise specified who are not eligible for ASCT.

European Commission Approves Zanubrutinib Tablet Formulation for All Indications in B-Cell Malignancies

August 21st 2025

The European approval of a zanubrutinb tablet formulation covers indications in CLL, Waldenström macroglobulinemia, MZL, and follicular lymphoma.

Alpha1H Demonstrates Clinical Benefit in NMIBC

August 21st 2025

Alpha1H met all primary and secondary end points in a phase 2 study in non–muscle-invasive bladder cancer.

Health Canada Approves Nivolumab Plus Ipilimumab for Unresectable MSI-H/dMMR CRC and Unresectable HCC

August 20th 2025

Nivolumab plus ipilimumab earned approval from Health Canada for select patients with unresectable colorectal cancer and hepatocellular carcinoma.

ATG-022 Earns Breakthrough Therapy Designation in China for Advanced Gastric/GEJ Adenocarcinoma

August 19th 2025

The NMPA has granted breakthrough therapy designation to ATG-022 for previously treated gastric and gastroesophageal junction adenocarcinoma.

Nirogacestat Wins EU Approval for Progressing Desmoid Tumors

August 18th 2025

The European Commission approved nirogacestat for the treatment of progressing desmoid tumors requiring systemic treatment.

PLD Plus Ifosfamide Shows Promising Activity in Advanced Soft Tissue Sarcoma

August 17th 2025

PLD plus ifosfamide produced an ORR of 33% and a DCR of 83% in advanced soft tissue sarcoma, with manageable toxicity.

Novel Lipo-MIT–Based Triplet Drives Responses in R/R Myeloma

August 15th 2025

Bortezomib plus mitoxantrone hydrochloride liposome and dexamethasone produced responses with manageable safety in relapsed/refractory myeloma

SHR-A1811 Monotherapy Generates Similar pCR Rate as PCbHP in HER2+ Breast Cancer

August 14th 2025

The antibody-drug conjugate SHR-A1811 demonstrated a comparable pCR rate to SHR-A1811/pyrotinib and PCbHP in HER2-positive breast cancer.

Anlotinib Plus Toripalimab Yields Antitumor Activity in Advanced Soft Tissue Sarcoma and Bone Sarcoma

August 13th 2025

Treatment with the combination of anlotinib and toripalimab produced durable efficacy in soft tissue sarcoma and bone sarcoma.

Health Canada Authorizes Perioperative Pembrolizumab in Resectable, Locally Advanced HNSCC

August 13th 2025

Perioperative pembrolizumab has received the green light for use in combination with radiotherapy with or without cisplatin in PD-L1–positive HNSCC.

Real-World Outcomes Support Use of First-Line Palbociclib Plus ET in HR+/HER2– Advanced Breast Cancer

August 12th 2025

Real-world data supported the clinical effectiveness of first-line palbociclib plus endocrine therapy in HR-positive, HER2-negative breast cancer.

iPETcertum Receives FDA Clearance for Assisting in PET, PET-CT/MRI Scans for Patients With Cancer and Suspicious Lesions

August 12th 2025

The FDA has cleared iPETcertum for PET and PET-CT/MRI scan enhancement in patients with cancer and suspicious lesions.

Sintilimab Plus Anlotinib Shows Durability in PD-L1+ Recurrent/Metastatic Cervical Cancer

August 11th 2025

Extended follow-up showed sintilimab plus anlotinib yielded durable efficacy and tolerability in PD-L1–positive recurrent/metastatic cervical cancer.

NMPA Accepts sNDA for Frontline Toripalimab Plus Disitamab Vedotin in HER2+ Urothelial Carcinoma

August 8th 2025

China’s NMPA has accepted the sNDA for first-line toripalimab plus disitamab vedotin in HER2-expressing locally advanced or metastatic urothelial carcinoma.