AstraZeneca's Enhertu receives FDA breakthrough designation for first-line treatment of HER2-positive breast cancer.

AstraZeneca and Daiichi Sankyo's Enhertu has received breakthrough therapy status from the US FDA for first-line treatment of metastatic HER2-positive breast cancer. This is the ninth breakthrough designation for Enhertu and the fifth in metastatic breast cancer. The therapy is already approved for patients who have received prior therapy.

AstraZeneca and Daiichi Sankyo's ENHERTU, a HER2-directed antibody-drug conjugate (ADC), has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. This is the ninth BTD for ENHERTU, and the fifth in metastatic breast cancer [1].

The designation is based on data from the DESTINY-Breast09 phase 3 trial, which demonstrated substantial improvement in progression-free survival (PFS) with ENHERTU plus pertuzumab compared to the current standard of care, THP (a taxane, trastuzumab, and pertuzumab) [1]. The median PFS with ENHERTU plus pertuzumab was over three years, an improvement over the standard of care that has been in place for over a decade [1].

ENHERTU is already approved for patients who have received prior therapy. This new BTD indicates its potential to significantly improve outcomes for patients with HER2-positive metastatic breast cancer in the first-line setting [1]. The designation is designed to accelerate the development and regulatory review of potential new medicines that address a significant unmet medical need [1].

The DESTINY-Breast09 trial enrolled 1,157 patients across multiple sites in Africa, Asia, Europe, North America, and South America. The primary endpoint was PFS as assessed by blinded independent central review in both the ENHERTU monotherapy and ENHERTU combination arms [1]. Secondary endpoints included investigator-assessed PFS, overall survival, objective response rate, duration of response, pharmacokinetics, and safety [1].

The approval of ENHERTU for first-line treatment of HER2-positive metastatic breast cancer represents a significant advancement in the treatment landscape for this aggressive disease. It highlights the potential of ADCs in improving patient outcomes and addresses an unmet medical need [1].

Reference list:
[1] https://www.biospace.com/press-releases/enhertu-plus-pertuzumab-granted-breakthrough-therapy-designation-in-the-u-s-as-first-line-therapy-for-patients-with-her2-positive-metastatic-breast-cancer