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.

Tislelizumab Plus Chemo Approved in China for PD-L1–High Advanced Gastric/GEJ Adenocarcinoma

February 27th 2023

The National Medical Products Administration of China has granted approval to tislelizumab in combination with fluoropyrimidine and platinum chemotherapy in the frontline treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma with a high PD-L1 expression.

Trastuzumab Deruxtecan Garners Approval in China for HER2+ Metastatic Breast Cancer

February 24th 2023

The National Medical Products Administration of China has approved the use of single-agent fam-trastuzumab deruxtecan-nxki in adult patients with unresectable or metastatic HER2-positive breast cancer who previously received 1 or more anti–HER2-based regimens.

Cemiplimab Plus Chemotherapy Approaches EU Approval for PD-L1+ NSCLC

February 24th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small cell lung cancer with PD-L1 expression of 1% or higher.

EU Approves Durvalumab/Tremelimumab Combo for Advanced Lung, Liver Cancers

February 22nd 2023

The European Union has approved durvalumab plus tremelimumab-actl for first-line treatment of advanced or unresectable hepatocellular carcinoma and in combination with platinum-based chemotherapy in metastatic non–small cell lung cancer, according to a news release from AstraZeneca.

Acalabrutinib Tablet Formulation Approved in Europe for Chronic Lymphocytic Leukemia

February 22nd 2023

The European Commission has approved the tablet formulation of acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia.

FDA Grants Priority Review to Elranatamab in Relapsed/Refractory Myeloma

February 22nd 2023

The FDA has granted a priority review to the biologics license application for elranatamab for the treatment of patients with relapsed/refractory multiple myeloma.

Toripalimab Plus Chemotherapy Meets PFS End Point in PD-L1+ TNBC

February 21st 2023

Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.

MHRA Approves Selinexor Plus Bortezomib/Dexamethasone for Multiple Myeloma Following 1 Prior Therapy

February 21st 2023

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted full marketing authorization for selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

NICE Recommends Axicabtagene Ciloleucel for Lymphoma

January 30th 2023

The United Kingdom’s National Institute for Health and Care Excellence has issued draft guidance supporting the use of axicabtagene ciloleucel for adults with diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma following at least 2 previous lines of systemic therapy.

European Commission Approves Trastuzumab Deruxtecan for HER2-Low Metastatic Breast Cancer

January 26th 2023

Fam-trastuzumab deruxtecan-nxki has received approval in the European Union as a single agent for the treatment of patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

UK’s MHRA Approves Zanubrutinib for CLL and MZL

January 19th 2023

The Medicines and Healthcare Products Regulatory Agency has approved zanubrutinib in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia and the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20–based therapy.

Mobocertinib Garners Approval in China for EGFR Exon 20 Insertion+ NSCLC

January 11th 2023

The National Medical Products Administration of China has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and whose disease progressed on or following platinum-based chemotherapy.

Duvelisib Wins Orphan Drug Designation for PTCL in Europe

January 10th 2023

The European Commission has issued an orphan drug designation to duvelisib for the treatment of adult patients with peripheral T-cell lymphoma.

IBI351 Gets Breakthrough Therapy Designation for KRAS G12C–Mutated NSCLC in China

January 10th 2023

The Center for Drug Evaluation of China's National Medical Products Administration has granted a breakthrough therapy designation to IBI351 for the treatment of patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation who have received at least 1 prior line of systemic therapy.

Japan Approves Acalabrutinib for Treatment-Naïve CLL

January 6th 2023

Japan’s Ministry of Health, Labor, and Welfare has approved acalabrutinib for the treatment of previously untreated patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Japan Approves Durvalumab/Tremelimumab Combo for HCC and Advanced NSCLC

January 6th 2023

Japan has approved durvalumab monotherapy and durvalumab plus tremelimumab for unresectable hepatocellular carcinoma, durvalumab plus tremelimumab and chemotherapy for unresectable, advanced, or recurrent non–small cell lung cancer, and durvalumab plus chemotherapy for curatively unresectable biliary tract cancer.

EMA Validates Type II Application for Trastuzumab Deruxtecan in Advanced HER2-Mutated NSCLC

January 4th 2023

The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.

Japan Approves Second-line Axi-cel for LBCL

December 23rd 2022

Japan’s Ministry of Health, Labor and Welfare has approved axicabtagene ciloleucel for the initial treatment of patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.

NICE Recommends Trastuzumab Deruxtecan for Previously Treated HER2+ Metastatic Breast Cancer

December 20th 2022

The United Kingdom’s National Institute for Health and Care Excellence has endorsed trastuzumab deruxtecan for use within the Cancer Drugs Fund for adult patients with HER2-positive, unresectable or metastatic breast cancer following at least 1 anti-HER2 treatment.

Durvalumab Misses OS End Point in PEARL Trial in Advanced, PD-L1–High NSCLC

December 19th 2022

Durvalumab monotherapy failed to elicit a statistically significant improvement in overall survival vs platinum-based chemotherapy as frontline treatment in patients with stage IV non–small cell lung cancer with at least 25% positivity of PD-L1 on tumor cells, or in a subgroup of patients at low risk of early mortality.