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.

EMA Validates Type II Application for Trastuzumab Deruxtecan in Advanced HER2-Mutated NSCLC

January 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 LBCL

December 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 Cancer

December 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 NSCLC

December 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 NSCLC

December 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 Cancer

December 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 Cancer

December 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 Japan

December 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 mCRPC

December 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 Cancer

December 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

December 9th 2022

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

December 9th 2022

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.

Development of Zandelisib for B-cell Malignancies Discontinued Outside of Japan

December 6th 2022

The development of zandelisib for the treatment of B-cell malignancies has been discontinued outside of Japan.

EMA Accepts Marketing Authorization Application for Momelotinib in Myelofibrosis

December 2nd 2022

The European Medicines Agency has accepted a marketing authorization application for momelotinib as a treatment for patients with myelofibrosis.

EMA Accepts Marketing Authorization Application for Aumolertinib in EGFR-Mutated NSCLC

December 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 Cholangiocarcinoma

December 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.

MHRA Approves Darolutamide Plus ADT and Docetaxel for Metastatic HSPC

November 29th 2022

The United Kingdom’s Medicines and Healthcare products Regulatory Agency has approved darolutamide tablets in combination with androgen deprivation therapy and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.

NICE Recommends Nivolumab/Chemo for HER2- Advanced Stomach and Esophageal Cancer

November 29th 2022

The United Kingdom’s National Institute for Health and Care Excellence has issued final guidance recommending the use of nivolumab plus chemotherapy as a treatment option for patients with HER2-negative advanced stomach and esophageal cancer.

European Commission Approves Cemiplimab for Recurrent or Metastatic Cervical Cancer

November 22nd 2022

The European Commission has approved cemiplimab-rwlc monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer who have progressed on or after platinum-based chemotherapy.

European Commission Approves Zanubrutinib for CLL

November 18th 2022

The European Commission has approved zanubrutinib for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia.