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.

Japanese Approval Sought for Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer

December 21st 2021

A supplemental new drug application has been submitted to Japan’s Ministry of Health, Labour, and Welfare or the use of fam-trastuzumab deruxtecan-nxki as a treatment in select patients with HER2-positive unresectable or recurrent breast cancer.

EU Panel Recommends Adjuvant Pembrolizumab for Select RCC Following Surgery

December 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of single-agent pembrolizumab for use as an adjuvant treatment in adult patients with renal cell carcinoma who are at increased risk of recurrence after nephrectomy, or following nephrectomy and the resection of metastatic lesions.

Enfortumab Vedotin Approaches EU Approval for Locally Advanced or Metastatic Urothelial Cancer

December 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of the approval of enfortumab vedotin as a monotherapy in the treatment of adult patients with locally advanced or metastatic urothelial cancer.

Niraparib Demonstrates PFS Benefit in Chinese Population With Advanced Ovarian Cancer

November 30th 2021

First-line maintenance treatment with the PARP inhibitor niraparib yielded a clinically meaningful and statistically significant improvement in progression-free survival vs placebo in Chinese patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status, according to data from the phase 3 PRIME trial.

Pembrolizumab/Axitinib Improves Outcomes in Japanese mRCC Subgroup

November 30th 2021

The combination of pembrolizumab and axitinib demonstrated comparable activity and safety vs sunitinib in Japanese patients vs the global population of patients with newly diagnosed metastatic renal cell carcinoma enrolled in the phase 3 KEYNOTE-426 trial.

Pembrolizumab/Lenvatinib Approved in Europe for Frontline RCC

November 29th 2021

The European Commission has approved the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced renal cell carcinoma.

European Commission Approves Pembrolizumab/Lenvatinib for Advanced or Recurrent Endometrial Cancer

November 29th 2021

The European Commission has granted an approval to the combination of pembrolizumab and lenvatinib for the treatment of patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior platinum-containing therapy in any setting and who are not eligible for curative surgery or radiation.

Sacituzumab Govitecan Approved in Europe for Second-Line Metastatic TNBC

November 23rd 2021

The European Commission granted marketing authorization for sacituzumab govitecan-hziy for use as a monotherapy in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have previously received 2 or more systemic therapies, at least 1 of them for advanced disease.

Pralsetinib Approved in Europe for RET Fusion+ Advanced NSCLC

November 19th 2021

The European Commission has granted a conditional marketing authorization to pralsetinib for use as a single agent in adult patient with RET fusion–positive advanced non–small cell lung cancer who did not previously receive a RET inhibitor.

Sacituzumab Govitecan Meets ORR End Point in Chinese Patients With Metastatic TNBC

November 17th 2021

Sacituzumab govitecan-hziy significantly improved overall response rate in Chinese patients with metastatic triple-negative breast cancer.

Sotorasib Approaches EU Approval for KRAS G12C–Mutated Advanced NSCLC

November 12th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization of sotorasib for the treatment of adult patients with advanced non–small cell lung cancer whose tumors harbor a KRAS G12C mutation and who have progressed after at least 1 prior line of systemic therapy.

Pembrolizumab/Chemo Approved in Europe for Select Locally Recurrent Unresectable or Metastatic TNBC

October 22nd 2021

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

Nivolumab/Chemo Approved in Europe for HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

October 21st 2021

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

Relatlimab/Nivolumab Application for Frontline Advanced Melanoma Validated by EMA

October 1st 2021

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Infigratinib Approved in Canada for FGFR2+ Cholangiocarcinoma

September 29th 2021

Health Canada has approved infigratinib for the treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring a FGFR2 fusion or other rearrangement.

Taletrectinib Elicits Encouraging Responses in Crizotinib-Pretreated ROS1+ NSCLC

September 28th 2021

The investigational next-generation ROS1/NTRK inhibitor taletrectinib was found to elicit encouraging responses with an acceptable toxicity profile in patients with ROS1-positive non–small cell lung cancer, according to preliminary data from the phase 2 TRUST trial.

Trastuzumab Deruxtecan Elicits Encouraging Activity in Western Patients With HER2+ Gastric/GEJ Cancer

September 17th 2021

Fam-trastuzumab deruxtecan-nxki as a second-line treatment elicited a 38% confirmed objective response rate in Western patients with HER2-positive gastric/gastroesophageal junction cancer.

Pembrolizumab/Chemo Nears EU Approval for Select TNBC With PD-L1 CPS ≥10

September 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

EU Panel Recommends Pralsetinib for RET Fusion+ Advanced NSCLC

September 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pralsetinib for use as a single agent in adult patients with RET fusion–positive advanced non–small cell lung cancer who did not receive prior RET inhibition.

Nivolumab/Chemo Approaches EU Approval for Select HER2– Advanced or Metastatic Gastric, GEJ, or Esophageal Adenocarcinoma

September 17th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.