Particle.news
Download on the App Store
6 ARTICLES
·
5d ago

FDA Clears Enhertu-Perjeta Combo for First-Line HER2-Positive Metastatic Breast Cancer

The decision follows phase 3 results showing a roughly 14-month median progression-free survival advantage over the THP regimen.

Image
Image
Image
AstraZeneca’s Enhertu combination approved by FDA for HER2-positive breast cancer

Overview

  • The approval is supported by DESTINY-Breast09, where Enhertu plus pertuzumab achieved median PFS of 40.7 months versus 26.9 months with THP (HR 0.56; P<0.0001).
  • Overall survival remains immature at the time of the PFS analysis, with deaths reported in 16% of patients across both arms.
  • Interstitial lung disease and pneumonitis were reported in 46 patients on the Enhertu combination, including two deaths, compared with four cases on THP.
  • The FDA acted well before its Jan. 23 decision date after granting Priority Review and Breakthrough Therapy designation.
  • The clearance is expected to influence frontline practice and triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo.