EMA's Advisory Committee Backs Approval For AstraZeneca's Targeted Breast Cancer Therapies

  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Enhertu (trastuzumab deruxtecan) as monotherapy for unresectable or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2-based regimens.
  • Enhertu is being jointly developed and commercialized by AstraZeneca Plc AZN and Daiichi Sankyo DSNKY.
  • Also Read: AstraZeneca-Daiichi Breast Cancer Drug Cuts Disease Progression Or Death Risk By Almost 50%.
  • The positive opinion is based on results from the DESTINY-Breast03 Phase 3 trial, in which Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.
  • CHMP also backed Lynparza (olaparib) as monotherapy or combined with endocrine therapy as adjuvant treatment of HER2-negative high-risk early breast cancer with germline BRCA1/2 mutations (gBRCAm) in previously treated patients with neoadjuvant or adjuvant chemotherapy.
  • Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.
  • Lynparza is jointly developed and commercialized by AstraZeneca and Merck & Co Inc MRK.
  • Price Action: AZN shares are down 0.48% at $66.58 during the premarket session on the last check Monday.

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