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.
Nivolumab/Ipilimumab Approved in Europe for Frontline Unresectable Malignant Pleural MesotheliomaJune 2nd 2021
The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.
Cemiplimab Granted Positive EU Opinion for Advanced NSCLC and Basal Cell CarcinomaMay 24th 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.
Frontline Pembrolizumab/Chemo Recommended for EU Approval for Select Esophageal or HER2-Negative GEJ AdenocarcinomaMay 24th 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.
Nivolumab/Ipilimumab Approaches EU Approval for Post-Chemo dMMR or MSI-H Metastatic CRCMay 24th 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the combination of nivolumab and ipilimumab as an option for patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following fluoropyrimidine-based combination therapy.
Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent or Metastatic Nasopharyngeal CancerMay 21st 2021
The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.
High-Grade ILD Prevention With Trastuzumab Deruxtecan Includes Early Detection, Optimal Management in HER2+ Metastatic Breast CancerMay 8th 2021
Effective early detection and optimal management are critical in preventing high-grade interstitial lung disease, a treatment-related adverse effect of fam-trastuzumab deruxtecan-nxki in patients with HER2-positive metastatic breast cancer.
HER2+ Breast Cancer With Immune-Related Gene Signatures May Be Eligible for De-Escalation ApproachesMay 8th 2021
Distinct gene signatures, with the exception of estrogen receptor signaling and BRCAness, are associated with pathologic complete response and invasive disease-free survival, in patients with HER2-positive breast cancer who received trastuzumab and pertuzumab alone or in combination with paclitaxel.
Shorter Duration of Adjuvant Trastuzumab Shows Long-Term Survival Benefit in Select HER2+ Early Breast CancerMay 8th 2021
Although administering trastuzumab for 1 year in patients with HER2-positive early breast cancer continues to be standard, a 9-week de-escalation approach may be a reasonable option in a large proportion of the real-world HER2-positive population.
Ribociclib/Endocrine Therapy Improves OS Regardless of Age in Advanced HR+/HER2- Breast CancerMay 7th 2021
Ribociclib plus endocrine therapy improved overall survival and post-progression outcomes in pre- or postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer irrespective of age.
Atezolizumab Plus Carboplatin Induces Early Efficacy Signals in Invasive Lobular Breast CancerMay 7th 2021
Treatment with atezolizumab plus carboplatin demonstrated early clinical activity in patients with metastatic invasive lobular breast cancer, with slight trends toward increased clinical benefit in patients with triple-negative ILC and responders with higher PD-L1 expression, according to initial findings of the non-randomized phase 2 GELATO trial.
Frontline Atezolizumab Approved in Europe for PD-L1–High Metastatic NSCLCMay 5th 2021
The European Commission has approved atezolizumab for use as a frontline treatment in patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and do not harbor EGFR or ALK aberrations.
Risk-Adapted Therapy Feasible in Newly Diagnosed Ultra High–Risk MyelomaApril 28th 2021
Centrally stratified risk-adapted clinical trials in patients with newly diagnosed multiple myeloma were shown to be feasible, addressing an unmet need and providing the opportunity for rapid clinical development of novel therapies.
EU Panel Recommends Adjuvant Osimertinib in Early-Stage EGFR+ NSCLCApril 26th 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
EMA Validates Type II Variation Marketing Authorization Application for Selinexor Triplet in Multiple MyelomaApril 26th 2021
The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.
EU Panel Recommends Nivolumab/Ipilimumab in Frontline Unresectable Malignant Pleural MesotheliomaApril 23rd 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.
Oral Azacitidine Recommended for EU Approval in AMLApril 23rd 2021
The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant
Venetoclax-Based Regimens Get European Nod for Newly Diagnosed, Chemo-Ineligible AMLApril 23rd 2021
The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
Dostarlimab Approved in Europe for Advanced dMMR Endometrial CancerApril 23rd 2021
The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.
Toripalimab/Chemo Combo Improves Survival in Frontline Esophageal Squamous Cell CarcinomaApril 22nd 2021
The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.
NICE Recommends Trastuzumab Deruxtecan in Advanced HER2+ Breast CancerApril 20th 2021
The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.
Tocilizumab May Have Activity Against COVID-19–Associated Cytokine Storm in MyelomaApril 20th 2021
Tocilizumab may represent a potential treatment option with double action against cytokine storm due to COVID-19 in a subset of patients with active multiple myeloma and severe infection with the virus.
Subcutaneous Daratumumab Plus VCd Approved in Canada for Newly Diagnosed Light Chain AmyloidosisApril 19th 2021
Health Canada has approved daratumumab injection, a subcutaneous formulation of daratumumab, for use in combination with bortezomib, cyclophosphamide, and dexamethasone in the treatment of patients with newly diagnosed light chain amyloidosis.
Isatuximab Plus Carfilzomib/Dexamethasone Approved in Europe for Relapsed MyelomaApril 19th 2021
The European Commission has approved isatuximab for use in combination with carfilzomib and dexamethasone in the treatment of patients with relapsed multiple myeloma who have received at least 1 previous therapy.