Nasdaq

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) ...
Nasdaq

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for the Treatment of HER2 Positive Advanced Gastric Cancer

Application based on DESTINY-Gastric01 and DESTINY-Gastric02 phase 2 trials Approximately one in five gastric cancers are HER2 positive.8,9 HER2 is a tyrosine kinase receptor growth promoting protein ...
AFP

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) in combination with pertuzumab for the first-line ...
AFP

ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 ...
RAPS

Asia-Pacific Roundup: Malaysia’s NPRA to start 1-year pilot of new variation application timelines

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is preparing to trial new timelines for variation applications to “provide greater clarity and more effective monitoring.” NPRA published ...