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.

Perioperative Durvalumab-Based Regimen Receives European Approval for Resectable NSCLC

April 4th 2025

Durvalumab has received perioperative approval in the European Union in patients with resectable non–small cell lung cancer based on data from AEGEAN.

T-DXd Wins EU Approval for HR+, HER2-Low or -Ultralow Metastatic Breast Cancer After Endocrine Therapy

April 4th 2025

The European Commission approved trastuzumab deruxtecan for HR-positive, HER2-low or -ultralow metastatic breast cancer after at least 1 endocrine therapy.

Acalabrutinib Produces High ORR in Chinese Patients With R/R CLL

April 4th 2025

Acalabrutinib was effective in a population of patients from China with relapsed/refractory CLL.

Axi-Cel Is Associated With Higher ORR, Increased CRS/ICANS vs Tisa-cel in Older Patients With R/R DLBCL

April 2nd 2025

Axi-cel led to higher response rates but increased toxicity vs tisa-cel in older patients with relapsed/refractory DLBCL.

Denosumab Biosimilars Earn Positive CHMP Opinion for Osteoporosis and Cancer-Related Bone Disease

April 2nd 2025

The EMA’s CHMP has issued a positive opinion for the denosumab biosimilars Osvyrti and Jubereq for the same indications as the reference products.

Tisotumab Vedotin Earns European Approval for Pretreated Recurrent/Metastatic Cervical Cancer

April 1st 2025

Tisotumab vedotin was granted approval by the EU for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

First-Line Acalabrutinib Plus BR Receives CHMP Recommendation for Mantle Cell Lymphoma

March 31st 2025

CHMP recommends EU approval of acalabrutinib plus chemoimmunotherapy for untreated mantle cell lymphoma.

Tislelizumab Plus Chemo Receives Positive CHMP Opinion for ES-SCLC

March 31st 2025

The EMA’s CHMP recommended the approval of first-line tislelizumab plus chemotherapy for extensive-stage small cell lung cancer.

CHMP Recommends Approval of Subcutaneous Nivolumab in Multiple Solid Tumors

March 28th 2025

Meta: The CHMP has recommended the European approval of subcutaneous nivolumab in solid tumors.

CHMP Offers Positive Opinion for Perioperative Nivolumab Plus Chemo in Resectable PD-L1+ NSCLC

March 28th 2025

The EMA’s CHMP has recommended the approval of perioperative nivolumab plus chemotherapy in resectable PD-L1–positive non–small cell lung cancer.

Tisotumab Vedotin Gains Japanese Approval for Advanced Cervical Cancer

March 27th 2025

Tisotumab vedotin has received Japanese approval for advanced cervical cancer following chemotherapy.

China’s NMPA Approves IND for SKB107 for Solid Tumor Bone Metastases

March 26th 2025

The investigational new drug application for the RDC SKB107 for the management of solid tumor bone metastases has been approved in China.

Olvi-Vec Plus Chemo Yields Disease Control in Platinum-Relapsed or -Refractory ES-SCLC

March 25th 2025

Olvi-vec plus chemotherapy led to disease control in extensive-stage small cell lung cancer that was relapsed/refractory to platinum chemotherapy.

EMA to Review Application for Expanded Indication for Sugemalimab in Unresectable NSCLC

March 24th 2025

A Type II variation application has been submitted to the EMA for the expanded approval of sugemalimab for unresectable stage III NSCLC.

NMPA Approves sNDA for Toripalimab Plus Bevacizumab in Advanced HCC

March 24th 2025

The combination of toripalimab and bevacizumab has been approved in China for the treatment of patients with unresectable or metastatic HCC.

NMPA Grants Conditional Approval to Tazemetostat for EZH2-Mutant R/R Follicular Lymphoma

March 21st 2025

China’s NMPA has granted conditional approval to the EZH2 inhibitor tazemetostat for patients with relapsed/refractory EZH2-mutated follicular lymphoma.

Fruquintinib/Sintilimab Generates Favorable PFS Outcomes in Advanced RCC

March 19th 2025

Second-line fruquintinib plus sintilimab improved PFS, ORR, and DOR outcomes vs everolimus or axitinib monotherapy in advanced/metastatic RCC.

HER2DX Affects Approximately 50% of Treatment Decisions for HER2+ Breast Cancer

March 18th 2025

HER2DX aided in HER2+ breast cancer therapy decisions and the pCR rate was comparable among those who did and did not have HER2DX-driven treatment changes.

Penpulimab Gains NMPA Approval for First-Line Treatment of Recurrent or Metastatic NPC

March 18th 2025

Penpulimab received NMPA approval for first-line use with chemotherapy in recurrent or metastatic nasopharyngeal carcinoma.

Durvalumab Secures EU Approval for LS-SCLC After CRT

March 17th 2025

The European Commission approved durvalumab for limited-stage small cell lung cancer without disease progression following chemoradiation.