- AstraZeneca and Daiichi Sankyo said Enhertu plus pertuzumab was approved in the EU as first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
- AstraZeneca said it completed a previously announced exclusive license agreement with Dizal for Zegfrovy, an oral EGFR inhibitor for lung cancer.
- The SANOVO Phase 3 trial of Tagrisso plus Orpathys showed a statistically significant improvement in progression-free survival versus Tagrisso alone, AstraZeneca said.
CAMBRIDGE, United Kingdom — AstraZeneca PLC and Daiichi Sankyo said Enhertu, also known as trastuzumab deruxtecan, in combination with pertuzumab has been approved in the European Union as first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer.
AstraZeneca said in an emailed press release today that the combination is the first new regimen in more than a decade for that first-line setting.
The companies did not disclose additional trial figures, survival data, or conditions attached to the approval in the emailed summary.
Dizal License Completed
Separately, AstraZeneca said it has completed a previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy, also known as sunvozertinib. The company described Zegfrovy as an oral irreversible EGFR inhibitor for patients with lung cancer.
The emailed summary did not state the financial terms of the license.
SANOVO Lung Cancer Trial
Positive high-level results from the Phase 3 SANOVO trial showed Tagrisso, also known as osimertinib, plus Orpathys, also known as savolitinib, demonstrated a statistically significant improvement in progression-free survival versus Tagrisso alone, AstraZeneca said.
The trial enrolled treatment-naive patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer and MET overexpression. AstraZeneca described the progression-free survival improvement as highly clinically meaningful. The emailed summary did not include hazard ratios, median progression-free survival, or overall survival data.
AstraZeneca is a British-Swedish pharmaceutical company headquartered in Cambridge.