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.

Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications

August 29th 2023

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.

Pembrolizumab Plus Trastuzumab and Chemotherapy Receives European Approval in HER2+ Gastric/GEJ Cancer

August 29th 2023

The European Commission has approved pembrolizumab for use in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic, HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with a combined positive score of at least 1.

European Medicines Agency Grants Orphan Drug Designation to Mitazalimab for Pancreatic Cancer

August 25th 2023

The European Medicines Agency has granted orphan drug designation to mitazalimab for use in patients with pancreatic cancer.

Sovleplenib Elicits Durable Responses in Primary Immune Thrombocytopenia

August 24th 2023

Sovleplenib provided a statistically significant and clinically meaningful increase in durable response rate over placebo in adult patients with primary immune thrombocytopenia in China.

Olaparib Plus Abiraterone Acetate Receives Japanese Approval for BRCA-Mutant mCRPC

August 24th 2023

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of olaparib plus abiraterone acetate and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated castration-resistant prostate cancer with distant metastasis.

Sunvozertinib Approved in China for NSCLC With EGFR Exon 20 Insertion Mutations

August 23rd 2023

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

Trastuzumab Deruxtecan Approved in Japan for HER2-Mutated Metastatic NSCLC

August 23rd 2023

Japan’s Ministry of Health, Labour, and Welfare has approved fam-trastuzumab deruxtecan-nxki for use in adult patients with unresectable advanced or recurrent, HER2-mutant non–small cell lung cancer that has progressed following chemotherapy.

Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma

August 22nd 2023

The European Commission has approved single-agent nivolumab for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.

Talquetamab Wins Approval in Europe for Relapsed/Refractory Myeloma

August 22nd 2023

The European Commission has granted conditional marketing authorization to talquetamab-tgvs monotherapy for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 3 prior therapies and have demonstrated disease progression on the last therapy.

European Commission Approves Reduced Dosing of Teclistamab in Relapsed/Refractory Myeloma

August 18th 2023

The European Commission has approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved a complete response or better for a minimum of 6 months.

EMA Accepts Marketing Application for Odronextamab in R/R DLBCL or Follicular Lymphoma

August 17th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

Oral ATO/ATRA/Ascorbic Acid Regimen Delivers Durable Responses in APL

August 15th 2023

Harry Gill, MD, discusses the importance of offering patients with APL an entirely oral treatment regimen, key efficacy findings from this trial, and the tolerability of this regimen.

BAT8006 Elicits Disease Control, Safety in Advanced Ovarian Cancer and Other Solid Tumors

August 14th 2023

Treatment with the folate receptor–α antibody-drug conjugate BAT8006 led to responses with a manageable safety profile in patients with advanced solid tumors, including ovarian cancer, breast cancer, and cervical cancer.

Glecirasib Receives Breakthrough Therapy Designation in China for KRAS G12C–Mutated Pancreatic Cancer

August 10th 2023

China’s Center for Drug Evaluation of the National Medical Products Administration has granted a breakthrough therapy designation to glecirasib for the treatment of patients with pancreatic cancer harboring a KRAS G12C mutation and who have progressed after frontline standard-of-care treatment.

EU Approves Piflufolastat (18F) PSMA PET Imaging Agent for Prostate Cancer

July 28th 2023

The European Commission has approved piflufolastat (18F) for the detection of prostate-specific membrane antigen–positive lesions with positron emission tomography in adults with prostate cancer.

Loncastuximab Tesirine BLA Receives Priority Review in China for Relapsed/Refractory DLBCL

July 24th 2023

The China National Medical Products Administration has accepted and granted priority review to the biologics license application seeking the approval of loncastuximab tesirine-lpyl for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma following at least 2 prior lines of systemic therapy.

CHMP Advises Against Adagrasib Approval for KRAS G12C–Mutant Advanced NSCLC

July 24th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the conditional marketing authorization application for adagrasib for the treatment of patients with KRAS G12C–mutated advanced non–small cell lung cancer.

JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

Teclistamab Snags Positive CHMP Opinion for Relapsed/Refractory Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of a Type II variation for teclistamab in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies.

CHMP Recommends Talquetamab Monotherapy for R/R Multiple Myeloma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended conditional marketing authorization of talquetamab for use as a single agent in adult patients with relapsed or refractory multiple myeloma who have previously received at least 3 therapies.