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.