AstraZeneca's ENHERTU and CALQUENCE Reach Key Regulatory Milestones in Oncology

AstraZeneca's CALQUENCE received FDA approval as the first all oral, fixed duration regimen for chronic lymphocytic leukemia and small lymphocytic lymphoma. The EMA validated AstraZeneca's application for ENHERTU as a monotherapy for HER2 positive breast cancer after neoadjuvant therapy.

The CALQUENCE plus venetoclax approval creates an all oral, fixed duration option in a setting where many patients have been treated with continuous BTK inhibitor regimens. CALQUENCE carries extensive warnings for infections, bleeding, cytopenias, second primary malignancies, cardiac arrhythmias and hepatotoxicity.

The DESTINY-Breast05 phase 3 trial demonstrated that ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1. The trial enrolled 1,635 patients across Asia, Europe, and North America. The European Medicines Agency has validated the marketing authorization application for ENHERTU, marking the commencement of the scientific review process.

Additional regulatory submissions for ENHERTU are underway, including its combination with pertuzumab for the treatment of unresectable or metastatic HER2 positive breast cancer. The EMA validation for ENHERTU in residual disease after neoadjuvant therapy opens up another potential use in earlier stage HER2 positive breast cancer.

These regulatory milestones expand AstraZeneca's oncology treatment options for blood cancers and breast cancer. The moves come as the shares trade around £152.18, with returns of 12.0% year to date, 30.3% over the past year and 148.9% over five years.