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.

Acalabrutinib Receives Approval in China for Relapsed/Refractory Mantle Cell Lymphoma

March 23rd 2023

Acalabrutinib has received conditional approval from the National Medical Products Administration in China for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

China ARCHES Study Meets Primary, Secondary End Points in Metastatic Prostate Cancer

March 14th 2023

Enzalutamide plus androgen deprivation therapy produced a statistically significant improvement in time to prostate-specific antigen progression compared with ADT and placebo in men with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 China ARCHES study.

China’s NMPA Accepts BLA for Enfortumab Vedotin in Locally Advanced/Metastatic Urothelial Cancer

March 10th 2023

The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.

EU Approves Luspatercept for Anemia in Patients with Non–Transfusion-Dependent Beta Thalassemia

March 7th 2023

The European Commission has granted a full marketing authorization to luspatercept-aamt for use in adult patients with anemia associated with non–transfusion-dependent β-thalassemia.

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.