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.

European Commission Approves Elacestrant for Pretreated, ESR1+, ER+/HER2– Breast Cancer

September 20th 2023

The European Commission has approved elacestrant for the treatment of postmenopausal women and men with estrogen receptor–positive, HER2-negative, locally advanced, or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least 1 line of endocrine therapy including a CDK4/6 inhibitor.

Tislelizumab Approved in Europe for Advanced ESCC After Platinum-Based Chemotherapy

September 19th 2023

The European Commission has approved tislelizumab monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Oral Decitabine and Cedazuridine Wins EU Approval for Newly Diagnosed AML

September 19th 2023

The European Commission has approved oral decitabine and cedazuridine for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for standard induction chemotherapy.

EMA Grants PRIME Designation to Iopofosine I-131 for Waldenström Macroglobulinemia

September 19th 2023

The European Medicines Agency has granted Priority Medicines designation to iopofosine I-131 for use in patients with Waldenström macroglobulinemia in patients who previously received at least 2 treatment regimens.

CHMP Recommends Against Renewal of Marketing Authorization for Belantamab Mafodotin in R/R Myeloma

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against renewal of the conditional marketing authorization for belantamab mafodotin-blmf for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 4 prior treatments.

Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer

September 18th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.

CHMP Releases Positive Opinion for Quizartinib in Newly Diagnosed FLT3-ITD+ AML

September 15th 2023

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed, FLT3-ITD–positive acute myeloid leukemia.

Trastuzumab Deruxtecan Receives CHMP Recommendation for Approval in HER2-Mutant NSCLC

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with HER2-mutated, advanced non–small cell lung cancer who require systemic treatment after platinum-based chemotherapy with or without immunotherapy.

Adjuvant Pembrolizumab Receives Positive CHMP Opinion for High-Risk NSCLC After Resection and Chemo

September 15th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab as adjuvant treatment for adult patients with non–small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Extended Melphalan Flufenamide Indication Approaches EU Approval for R/R Multiple Myeloma

September 14th 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion regarding a Type II variation application to extend the therapeutic indication of melphalan flufenamide for use in adult patients with multiple myeloma who have received at least 2 prior lines of treatment and whose disease is refractory to lenalidomide and the last line of therapy.

NICE Recommends Ruxolitinib for Hydroxycaramide/Hydroxyurea Resistant or Intolerant Polycythemia Vera

September 14th 2023

The National Institute for Health and Care Excellence has published its Final Draft Guidance recommending the use of ruxolitinib as treatment for eligible patients in England and Wales with polycythemia vera that is resistant or intolerant to hydroxycarbamide/hydroxyurea.

Golidocitinib NDA Under NMPA Review for Relapsed/Refractory PTCL

September 14th 2023

The Center for Drug Evaluation of China’s National Medical Products Administration has accepted the new drug application seeking the approval of golidocitinib for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma.

EMA Validates Type II Variation Application for Enzalutamide in Nonmetastatic Hormone-Sensitive Prostate Cancer

September 13th 2023

The European Medicines Agency has validated its Type II variation for enzalutamide as an option in patients with nonmetastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence who are not suitable for salvage radiotherapy.

European Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma

September 12th 2023

A marketing authorization application has been submitted to the European Medicines Agency seeking the approval of erdafitinib for the treatment of adult patients with locally advanced, unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who experienced disease progression during or following at least 1 line of therapy containing a PD-1/PD-L1 inhibitor.

Neoadjuvant Durvalumab Plus Chemo Followed by Adjuvant Durvalumab Does Not Provide Benefit for EGFR+ NSCLC

September 11th 2023

The addition of durvalumab to chemotherapy prior to surgery, followed by adjuvant durvalumab, did not provide a clear clinical benefit in patients with early-stage non–small cell lung cancer harboring an EGFR mutation, according to data from the phase 3 AEGEAN trial.

Sacituzumab Govitecan Plus Pembrolizumab Evokes Clinical Activity as Frontline Treatment for Metastatic NSCLC

September 10th 2023

Early antitumor activity has been observed in patients with metastatic non–small cell lung cancer treated with the combination of sacituzumab govitecan-hziy and pembrolizumab in the first-line setting.

Tagraxofusp Receives Orphan Drug Designation in Japan for BPCDN

August 31st 2023

The Japanese Ministry of Health, Labor and Welfare has granted an orphan drug designation to tagraxofusp-erzs for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm.

Repotrectinib Gets Breakthrough Therapy Designation in China for NTRK+ TKI-Pretreated Solid Tumors

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted breakthrough therapy designation to repotrectinib for use in patients with advanced solid tumors harboring a NTRK gene fusion who experienced disease progression after TKI treatment.

Savolitinib Wins Breakthrough Therapy Designation in China for Gastric Cancer With MET Amplification

August 30th 2023

The Center for Drug Evaluation, of the National Medical Products Administration in China, has granted a breakthrough therapy designation to savolitinib for use in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction with MET amplification in whom at least 2 lines of standard therapy have failed.

Subcutaneous Atezolizumab Approved in Great Britain for All Intravenous Indications

August 29th 2023

Great Britain’s Medicines and Healthcare Products Regulatory Agency has approved subcutaneous atezolizumab for all indications in which the intravenous formulation of the drug has been approved, including select types of lung, bladder, breast, and liver cancers.