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.

Zanubrutinib sBLA for Waldenström Macroglobulinemia Accepted in China

January 21st 2022

The China National Medical Products Administration has accepted a supplemental new drug application for zanubrutinib as a treatment for adult patients with Waldenström macroglobulinemia.

Key Markers in Gut Microbiome May Predict Skin-Related AEs With Nivolumab in Advanced Gastric Cancer

January 20th 2022

The presence of Arthrobacter and fatty acid metabolism pathways in gut microbiomes may be linked to an increased risk of skin-related adverse events in patients with advanced gastric cancer who are receiving single-agent nivolumab.

Idecabtagene Vicleucel Approved in Japan for Relapsed/Refractory Multiple Myeloma

January 20th 2022

The Japanese Ministry of Health, Labour, and Welfare has approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 3 therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have progressed on their last therapy or relapsed following their last therapy.

Nivolumab Misses Mark in Japanese Patients With Platinum-Resistant Ovarian Cancer

January 18th 2022

Nivolumab did not significantly improve overall survival compared with chemotherapy in Japanese patients with platinum-resistant ovarian cancer.

NHS Scotland Accepts Trastuzumab Deruxtecan for Use in HER2+ Metastatic Breast Cancer

January 17th 2022

The Scottish Medicines Consortium has accepted fam-trastuzumab deruxtecan-nxki as a treatment option for adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received 2 or more anti–HER2-based therapies.

Sotorasib Approved in Europe for KRAS G12C–Mutated Advanced NSCLC

January 10th 2022

The European Commission has granted conditional marketing authorization to sotorasib for the treatment of adult patients with KRAS G12C mutant advanced non–small cell lung cancer.

Japanese Approval Sought for Valemetostat in Relapsed/Refractory Adult T-Cell Leukemia/Lymphoma

January 3rd 2022

A new drug application seeking the approval of valemetostat tosylate for use in the treatment of patients with relapsed/refractory adult T-cell leukemia/lymphoma has been submitted to the Japanese Ministry of Health, Labour, and Welfare.

Pembrolizumab/Lenvatinib Approved in Japan for Endometrial Cancer Following Progression on Chemo

January 3rd 2022

The Japanese Ministry of Health, Labour, and Welfare has approved the combination of pembrolizumab plus lenvatinib for use in patients with unresectable, advanced, or recurrent endometrial carcinoma that has progressed on chemotherapy.

Selinexor Approved in China for Relapsed or Refractory Multiple Myeloma

December 22nd 2021

The China National Medical Products Administration has granted a conditional marketing approval to selinexor for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received treatment and whose disease is refractory to at least a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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.