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 ...
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 ...