TECVAYLI® (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy

Application supported by Phase 3 data reinforcing teclistamab regimens as a potential standard of care after at least one prior therapy1 Teclistamab monotherapy delivered superior progression-free ...
Seeking Alpha

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

Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current ...

JNJ Seeks Label Expansion of Multiple Myeloma Drug Tecvayli in the EU

Johnson & Johnson seeks EMA nod to expand Tecvayli monotherapy use in earlier-line RRMM, backed by phase III MajesTEC-9 data ...
Pharmabiz

EMA validates Type II Variation marketing application for Enhertu as post-neoadjuvant treatment for patients with HER2 positive earlybreast 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 positive ...