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.
March 14th 2023
Enzalutamide plus androgen deprivation therapy produced a statistically significant improvement in time to prostate-specific antigen progression compared with ADT and placebo in men with metastatic hormone-sensitive prostate cancer, meeting the primary end point of the phase 3 China ARCHES study.
Cemiplimab Plus Chemotherapy Approaches EU Approval for PD-L1+ NSCLCFebruary 24th 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab-rwlc in combination with platinum-based chemotherapy as frontline treatment for adult patients with advanced non–small cell lung cancer with PD-L1 expression of 1% or higher.
EU Approves Durvalumab/Tremelimumab Combo for Advanced Lung, Liver CancersFebruary 22nd 2023
The European Union has approved durvalumab plus tremelimumab-actl for first-line treatment of advanced or unresectable hepatocellular carcinoma and in combination with platinum-based chemotherapy in metastatic non–small cell lung cancer, according to a news release from AstraZeneca.
Toripalimab Plus Chemotherapy Meets PFS End Point in PD-L1+ TNBCFebruary 21st 2023
Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.
MHRA Approves Selinexor Plus Bortezomib/Dexamethasone for Multiple Myeloma Following 1 Prior TherapyFebruary 21st 2023
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has granted full marketing authorization for selinexor in combination with bortezomib and low-dose dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.
NICE Recommends Axicabtagene Ciloleucel for LymphomaJanuary 30th 2023
The United Kingdom’s National Institute for Health and Care Excellence has issued draft guidance supporting the use of axicabtagene ciloleucel for adults with diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma following at least 2 previous lines of systemic therapy.
European Commission Approves Trastuzumab Deruxtecan for HER2-Low Metastatic Breast CancerJanuary 26th 2023
Fam-trastuzumab deruxtecan-nxki has received approval in the European Union as a single agent for the treatment of patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
UK’s MHRA Approves Zanubrutinib for CLL and MZLJanuary 19th 2023
The Medicines and Healthcare Products Regulatory Agency has approved zanubrutinib in Great Britain for both the treatment of adult patients with chronic lymphocytic leukemia and the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20–based therapy.
Mobocertinib Garners Approval in China for EGFR Exon 20 Insertion+ NSCLCJanuary 11th 2023
The National Medical Products Administration of China has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations and whose disease progressed on or following platinum-based chemotherapy.
IBI351 Gets Breakthrough Therapy Designation for KRAS G12C–Mutated NSCLC in ChinaJanuary 10th 2023
The Center for Drug Evaluation of China's National Medical Products Administration has granted a breakthrough therapy designation to IBI351 for the treatment of patients with advanced non–small cell lung cancer harboring a KRAS G12C mutation who have received at least 1 prior line of systemic therapy.
Japan Approves Durvalumab/Tremelimumab Combo for HCC and Advanced NSCLCJanuary 6th 2023
Japan has approved durvalumab monotherapy and durvalumab plus tremelimumab for unresectable hepatocellular carcinoma, durvalumab plus tremelimumab and chemotherapy for unresectable, advanced, or recurrent non–small cell lung cancer, and durvalumab plus chemotherapy for curatively unresectable biliary tract cancer.
EMA Validates Type II Application for Trastuzumab Deruxtecan in Advanced HER2-Mutated NSCLCJanuary 4th 2023
The European Medicines Agency has validated an application for the use of trastuzumab deruxtecan for adults with previously treated unresectable or metastatic non–small cell lung cancer whose tumors have activating HER2 mutations.
Japan Approves Second-line Axi-cel for LBCLDecember 23rd 2022
Japan’s Ministry of Health, Labor and Welfare has approved axicabtagene ciloleucel for the initial treatment of patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma.
NICE Recommends Trastuzumab Deruxtecan for Previously Treated HER2+ Metastatic Breast CancerDecember 20th 2022
The United Kingdom’s National Institute for Health and Care Excellence has endorsed trastuzumab deruxtecan for use within the Cancer Drugs Fund for adult patients with HER2-positive, unresectable or metastatic breast cancer following at least 1 anti-HER2 treatment.
Durvalumab Misses OS End Point in PEARL Trial in Advanced, PD-L1–High NSCLCDecember 19th 2022
Durvalumab monotherapy failed to elicit a statistically significant improvement in overall survival vs platinum-based chemotherapy as frontline treatment in patients with stage IV non–small cell lung cancer with at least 25% positivity of PD-L1 on tumor cells, or in a subgroup of patients at low risk of early mortality.
UK Accepts Marketing Authorization Application for Sugemalimab in Metastatic NSCLCDecember 19th 2022
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has accepted a marketing authorization application seeking approval for sugemalimab plus chemotherapy as first-line treatment for patients with metastatic non–small cell lung cancer.
European Commission Approves Trastuzumab Deruxtecan in Pretreated HER2+ Advanced Gastric/GEJ CancerDecember 19th 2022
The European Commission has approved fam-trastuzumab deruxtecan-nxki as monotherapy for the treatment of patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
European Commission Recommends Trastuzumab Deruxtecan for HER2-Low Metastatic Breast CancerDecember 19th 2022
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval for the use of trastuzumab deruxtecan monotherapy for adults with unresectable or metastatic HER2-low breast cancer.
Trastuzumab Deruxtecan sNDA for HER2-Mutant Metastatic NSCLC Submitted for Review in JapanDecember 15th 2022
Daiichi Sankyo has filed a supplemental new drug application with Japan’s Ministry of Health, Labor, and Welfare for the use of fam-trastuzumab deruxtecan-nxki in adults with previously treated HER2-mutant unresectable advanced or recurrent non–small cell lung cancer.
European Commission Approves Pluvicto for PSMA-Positive mCRPCDecember 13th 2022
The European Commission has approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto) in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer.
Neoadjuvant Olaparib Combo Fails to Surpass Carboplatin/Paclitaxel in HER2– Early Breast CancerDecember 9th 2022
Long-term clinical data failed to show a benefit of neoadjuvant olaparib (Lynparza) plus paclitaxel vs carboplatin plus paclitaxel in patients with HER2-negative early breast cancer with homologous recombination deficiency.
Neoadjuvant Nivolumab Plus Chemotherapy Bests Nivolumab Alone in Resectable NSCLC
Neoadjuvant treatment with nivolumab (Opdivo) plus platinum doublet chemotherapy showed superior major pathological response rates and pathological complete response rates compared with nivolumab monotherapy among patients with resectable non–small cell lung cancer even for patients with a PD-L1 expression of 50% or greater.
CTC Count-driven Approach to First-line Treatment in Metastatic Breast Cancer Improves Survival
Using circulating tumor cell count as a guide to first-line treatment, either with chemotherapy or endocrine therapy, resulted in an improvement in overall survival compared with physician’s choice of treatment without CTC count for patients with metastatic, hormone receptor–positive/HER2-negative breast cancer.
EMA Accepts Marketing Authorization Application for Aumolertinib in EGFR-Mutated NSCLCDecember 2nd 2022
Pharmaceutical manufacturer EQRx announced December 2, 2022, that the European Medicines Agency has accepted a marketing authorization application for the use of aumolertinib in EGFR-mutated non–small cell lung cancer and locally advanced or metastatic EGFR T790M mutation–positive NSCLC.
Helsinn Birex Pharmaceuticals Withdraws European MAA for Infigratinib for Advanced CholangiocarcinomaDecember 1st 2022
The European marketing authorization application of infigratinib for the treatment of advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements has been withdrawn by Helsinn Birex Pharmaceuticals.