AstraZeneca's Enhertu Approved for First-Line Breast Cancer Treatment

AstraZeneca and Daiichi Sankyo's Enhertu has received FDA approval for first-line treatment of advanced HER2-positive breast cancer, marking the first new treatment option in this category in a decade.

This approval targets adults with unresectable or metastatic breast cancer that is HER2 positive, a protein that contributes to aggressive tumor behavior. Enhertu aims to improve long-term outcomes for patients, as many do not survive long enough to receive second-line treatments.

The approval is based on a Phase 3 study comparing Enhertu with the standard three-drug regimen known as THP, which consists of taxane, trastuzumab, and pertuzumab. The study showed a median progression-free survival of 40.7 months for patients receiving Enhertu plus Perjeta, compared to 26.9 months for the THP group.

The FDA also approved two companion diagnostics to determine patient eligibility for Enhertu. Enhertu was initially approved as a third-line treatment in 2019 and moved to second-line in 2022. The recent approval includes the use of Enhertu in combination with Perjeta.

AstraZeneca's executive vice president, Dave Fredrickson, emphasized the importance of this advancement for optimizing efficacy in treating HER2-positive metastatic breast cancer. Dr. Sara Tolaney from Dana-Farber Cancer Institute believes that Enhertu plus Perjeta should establish a new standard of care for this patient population.

Following this approval, Daiichi Sankyo is set to receive a $150 million milestone payment from AstraZeneca, as the partners reported $3.7 billion in combined Enhertu sales for 2024, a 46% increase from the previous year.

Enhertu was discovered by Daiichi Sankyo and AstraZeneca has been collaborating with the company since before its first FDA approval, sharing global development and commercialization rights, except in Japan.