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.

Pluvicto Receives Support for European Approval in PSMA-Positive mCRPC

October 14th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of Lutetium 177 vipivotide tetraxetan in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition for the treatment of adult patients with progressive prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane-based chemotherapy.

EMA Endorses Cemiplimab Approval in Advanced Cervical Cancer

October 14th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for cemiplimab monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after platinum-based chemotherapy.

Japan Green Lights Valemetostat Tosilate for Relapsed/Refractory Adult T-cell Leukemia/Lymphoma

September 26th 2022

The Japan Ministry of Health, Labor and Welfare has approved valemetostat tosilate for the treatment of patients with relapsed or refractory adult T-cell leukemia/lymphoma.

China Green Lights Olaparib for First-line Maintenance in HRD+ Advanced Ovarian Cancer

September 22nd 2022

Olaparib plus bevacizumab was approved in China as a first-line maintenance treatment for homologous recombination deficiency–positive ovarian cancer following a response to platinum-based chemotherapy plus bevacizumab.

Frontline Toripalimab Plus Chemotherapy Approved in China for Advanced Nonsquamous NSCLC

September 20th 2022

The China National Medical Products Administration has approved the supplemental new drug application seeking the approval of toripalimab plus pemetrexed and platinum as a frontline treatment in unresectable, locally advanced or metastatic, nonsquamous non–small cell lung cancer not harboring EGFR mutations or ALK fusions.

Zanubrutinib Approaches European Approval for Marginal Zone Lymphoma

September 19th 2022

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of zanubrutinib for use in adult patients with marginal zone lymphoma who have received at least 1 prior anti–CD20-based therapy.

Relatlimab Plus Nivolumab Approved in Europe for Unresectable or Metastatic Melanoma with PD-L1 <1%

September 17th 2022

The European Commission has approved the fixed-dose combination of relatlimab plus nivolumab for use in the frontline treatment of select patients with advanced or metastatic melanoma and a PD-L1 expression of less than 1% on tumor cells.

Tislelizumab Provides Favorable Efficacy in Asian and Non-Asian Patients with Previously Treated Advanced NSCLC

September 12th 2022

Tislelizumab continued to demonstrate an improved clinical benefit compared with docetaxel in both Asian and non-Asian patients with previously treated advanced non–small cell lung cancer.

European Commission Grants Orphan Drug Designation to Nana-val for Peripheral T-cell Lymphoma

September 8th 2022

The European Commission has granted an orphan drug designation to nanatinostat and valganciclovir for use as a potential therapeutic option in patients with peripheral T-cell lymphoma.

Approval Sought for Tafasitamab/Lenalidomide Combo in R/R DLBCL in Hong Kong

August 31st 2022

The Hong Kong Special Administrative Region’s Department of Health has accepted for review a biologics license application seeking the approval of tafasitamab plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma.

Daiichi Sankyo Submits sNDA for Quizartinib in Newly Diagnosed FLT3-ITD+ AML in Japan

August 30th 2022

Daiichi Sankyo submitted a supplemental new drug application to Japan’s Ministry of Health, Labor, and Welfare for the use of quizartinib in patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

EU Approves Asciminib for Ph+ CML in Chronic Phase After 2 or More TKIs

August 29th 2022

The European Commission has approved asciminib for the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who received prior treatment with at least 2 TKIs

Adjuvant Osimertinib Gets Japanese Approval for Early-Stage, EGFR-Mutated NSCLC

August 26th 2022

The Japanese Ministry of Health, Labour, and Welfare has approved osimertinib for use as an adjuvant treatment in patients with EGFR-mutated non–small cell lung cancer.

Fixed-Duration Ibrutinib Plus Venetoclax Wins EU Approval in Previously Untreated CLL

August 25th 2022

The European Commission has approved the fixed-duration, all-oral combination of ibrutinib and venetoclax for the frontline treatment of adult patients with chronic lymphocytic leukemia.

European Commission Grants Conditional Marketing Authorization to Teclistamab for Multiple Myeloma

August 24th 2022

The European Commission has granted conditional marketing authorization to teclistamab for use as a single agent in adult patients with relapsed and refractory multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

European Union Green Lights PD-L1 Companion Diagnostic for Adjuvant Atezolizumab in NSCLC

August 24th 2022

CE label expansion was granted to the Ventana PD-L1 assay for use as a companion diagnostic to identify patients with non–small cell lung cancer who are eligible for treatment with adjuvant atezolizumab.

Tislelizumab/Chemo Combo Takes Step Toward Chinese Approval for Unresectable ESCC

August 23rd 2022

The China National Medical Products Administration’s Center for Drug Evaluation has accepted for review a supplemental biologics application seeking the approval of tislelizumab plus chemotherapy in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

EMA Accepts Marketing Authorization Application for Fixed-Dose Decitabine/Cedazuridine Combo in AML

August 22nd 2022

The European Medicines Agency has accepted the marketing authorization application for the oral fixed-dose combination of decitabine and cedazuridine for the frontline treatment of adults with acute myeloid leukemia who are not candidates for standard induction chemotherapy.

EMA Accepts Marketing Authorization Application for Elacestrant in ER+/HER2- Advanced Breast Cancer

August 22nd 2022

The European Medicines Agency has validated a marketing authorization application for elacestrant for estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer.

UK’s MHRA Extends Conditional Marketing Authorization for Trastuzumab Deruxtecan to Select HER2+ Metastatic Breast Cancer

August 18th 2022

The United Kingdom Medicines and Healthcare Products Regulatory Agency has extended the conditional marketing authorization of fam-trastuzumab deruxtecan-nxki for single-agent use in adult patients in Great Britain who have HER2-positive unresectable or metastatic breast cancer and have received 1 or more prior HER2-based regimens.