Daiichi Sankyo: Enhertu Plus Pertuzumab Approved in the EU as First New Regimen in More than a Decade for First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

AstraZeneca (AZN) and Ionis Pharmaceuticals (IONS) discontinued a phase 3 trial for Wainua, a combination therapy for ATTR-CM. Analysts debate whether Alnylam Pharmaceuticals (ALNY) can succeed with its RNA silencing drugs in this area. ALNY's drugs are being considered for use with standard TTR stabilizers, targeting the disease through different pathways. The outcome may impact the ATTR-CM market and RNA therapeutics sector.

AstraZeneca (LSE:AZN) announced several oncology advancements, including EU approval for Enhertu plus pertuzumab in HER2-positive metastatic breast cancer, positive late-stage results for Tagrisso plus Orpathys in lung cancer, and a global license agreement for ZEGFROVY. TEZSPIRE showed positive phase III results in eosinophilic esophagitis. These updates highlight AstraZeneca's pipeline growth and potential revenue opportunities in cancer and immune-driven diseases.

AstraZeneca (AZN) completed an exclusive license agreement with Dizal Pharmaceutical for ZEGFROVY, a lung cancer treatment. AZN gained worldwide rights to develop and commercialize the drug, approved in the US and China for 2nd-line treatment of NSCLC with EGFR exon 20 insertion mutations. The drug will launch in the US in Q4 2026. The FDA accepted a supplemental application for 1st-line use, supported by positive trial results.

AstraZeneca and Daiichi Sankyo's Enhertu, combined with pertuzumab, received EU approval for treating HER2-positive metastatic breast cancer. The approval follows positive trial results showing a 44% reduction in disease progression risk and a median PFS of 40.7 months. AstraZeneca will pay Daiichi Sankyo $100m for this indication.

AstraZeneca (AZN) and Daiichi Sankyo received EU approval for Enhertu plus Pertuzumab to treat HER2-positive metastatic breast cancer. The combination reduced disease progression or death risk by 44% in a Phase 3 trial, with median progression-free survival of 40.7 months. AstraZeneca will pay Daiichi Sankyo a $100 million milestone payment. AZN stock closed at $162.13, down 0.35%.

AstraZeneca (NYSE:AZN) reported positive Phase 3 trial results for Tagrisso combined with Orpathys in non-small cell lung cancer, meeting primary endpoints. The EU approved Enhertu for metastatic HER2-positive breast cancer, reducing progression risk by 44%. AZN shares fell 0.81% premarket.