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.

Ide-Cel Wins Japanese Approval in Early Relapsed/Refractory Multiple Myeloma

December 14th 2023

Idecabtagene vicleucel has received marketing and manufacturing approval in Japan for its supplemental new drug application in patients with relapsed/refractory multiple myeloma who have received at least 2 prior lines of therapy.

Axatilimab Elicits Responses With Manageable Safety in Recurrent/Refractory cGVHD

December 11th 2023

Axatilimab induced rapid and durable responses with an acceptable toxicity profile at all doses analyzed with highest efficacy observed at the 0.3-mg/kg dose in patients with recurrent or refractory chronic graft-vs-host disease.

EMA Validates Application for Epcoritamab in Relapsed/Refractory Follicular Lymphoma

November 27th 2023

The European Medicines Agency has validated a type II application for the investigational T-cell engaging bispecific antibody epcoritamab-bysp for patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of therapy

Taletrectinib Under NMPA Review in China for Advanced or Metastatic ROS1+ NSCLC

November 22nd 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of the next-generation ROS1 TKI taletrectinib for the treatment of patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer with prior exposure to a ROS1 TKI.

Sugemalimab Receives Approval in China for Relapsed/Refractory Extranodal NK/T-cell Lymphoma

November 22nd 2023

The National Medical Products Administration of China has approved sugemalimab for use in patients with relapsed or refractory extranodal natural killer/T-cell lymphoma.

Rucaparib Receives EC Approval for Advanced Ovarian Cancer

November 20th 2023

The European Commission has approved rucaparib as first-line maintenance therapy for patients with advanced ovarian cancer, regardless of BRCA mutation status, who have responded following the completion of frontline platinum-based chemotherapy.

Zanubrutinib Plus Obinutuzumab Gets EU Approval for R/R Follicular Lymphoma

November 17th 2023

The European Commission has granted marketing authorization to the combination of zanubrutinib and obinutuzumab for the treatment of adult patients with relapsed/refractory follicular lymphoma following at least 2 prior lines of systemic therapy.

Vebreltinib Receives Approval in China For MET Exon 14+ NSCLC

November 16th 2023

China’s National Medical Products Administration has granted conditional marketing approval to vebreltinib for the treatment of patients with non–small cell lung cancer harboring MET exon 14 skipping mutations.

Durvalumab Plus Chemo Wins Approval in China For Advanced/Metastatic Biliary Tract Cancer

November 14th 2023

China’s National Medical Products Administration has approved durvalumab plus gemcitabine and cisplatin for frontline use in adult patients with locally advanced or metastatic biliary tract cancer.

CHMP Supports Approval of Subcutaneous Atezolizumab for All Current IV Indications

November 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of subcutaneous atezolizumab for all indications in which the intravenous formulation is approved, including certain types of lung, liver, bladder, and breast cancer

Momelotinib Approaches EU Approval for Myelofibrosis With Anemia

November 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion supporting the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anemia with primary myelofibrosis, post–polycythemia vera myelofibrosis, or post–essential thrombocytopenia myelofibrosis who have not been exposed to a JAK inhibitor or who had received prior ruxolitinib.

CHMP Recommends Adagrasib for Pretreated KRAS G12C+ Advanced NSCLC

November 14th 2023

After a re-examination procedure, the European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion on the conditional marketing authorization application for adagrasib in the treatment of adult patients with KRAS G12C–mutated advanced non–small cell lung cancer whose disease progressed following at least 1 prior systemic treatment.

Frontline Pembrolizumab Plus Chemo Approaches EU Approval for Biliary Tract Cancer

November 10th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) combined with gemcitabine and cisplatin in the frontline treatment of adult patients with locally advanced unresectable or metastatic biliary tract cancer

Frontline Cadonilimab Plus Chemotherapy Improves OS in Advanced Gastric/GEJ Adenocarcinoma

November 7th 2023

First-line treatment with the PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine led to a statistically significant improvement in overall survival vs placebo plus oxaliplatin and capecitabine in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, meeting the primary end point of the phase 3 AK104-302 trial.

EU Approval Sought for Encorafenib/Binimetinib in BRAF V600+ Advanced NSCLC

November 2nd 2023

The European Medicines Agency had validated a marketing authorization application seeking the approval of the combination of encorafenib and binimetinib for the treatment of adult patients with BRAF V600–mutant advanced non–small cell lung cancer.

Elranatamab Approaches EU Approval for Heavily Pretreated Relapsed/Refractory Multiple Myeloma

November 1st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of elranatamab-bcmm for the treatment of adult patients with relapsed/refractory multiple myeloma who were previously treated with 3 or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and who experienced disease progression on their last therapy.

EMA Validates Application for Frontline Nivolumab Plus Chemo in Advanced Urothelial Cancer

October 30th 2023

The European Medicines Agency has validated a type II variation application for the first-line combination of nivolumab and cisplatin-based chemotherapy for adult patients with unresectable or metastatic urothelial carcinoma.

EMA Accepts Marketing Authorization Application for Mirvetuximab Soravtansine in FRα+, Platinum-Resistant Ovarian Cancer

October 27th 2023

The European Medicines Agency has accepted a marketing authorization application seeking the approval of mirvetuximab soravtansine-gynx for the treatment of patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Dr Schmid on Key Efficacy Findings With Dato-DXd in Metastatic TNBC

October 25th 2023

Peter Schmid, FRCP, MD, PhD, discusses key findings from the phase 1/2 BEGONIA trial in patients with unresectable, metastatic or locally advanced triple-negative breast cancer, highlighting the clinical significance of these findings.

Epcoritamab Receives UK Approval for R/R DLBCL After 2 Prior Lines of Therapy

October 24th 2023

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted conditional marketing authorization to epcoritamab-bysp monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapy.