Wedoany.com Report-Dec.16, The U.S. Food and Drug Administration announced on Monday the approval of Enhertu, developed by AstraZeneca and Daiichi Sankyo, for use in combination with Roche's Perjeta as a first-line therapy for adults with advanced HER2-positive breast cancer. Eligibility requires confirmation through an FDA-approved diagnostic test.

Enhertu, an antibody-drug conjugate that targets HER2-positive cancer cells to deliver chemotherapy while sparing healthy tissue, initially received U.S. approval in late 2019 for third-line treatment of HER2-positive breast cancer. It has since gained indications for specific gastric and lung cancers.

Perjeta, originally developed by Genentech and approved in June 2012, is established for use alongside trastuzumab and chemotherapy in previously untreated HER2-positive metastatic breast cancer.

The latest approval also includes clearance for two companion diagnostic tests to accurately identify suitable patients for the Enhertu-Perjeta regimen.

Clinical evidence supporting the decision comes from a study involving 1,157 patients with advanced HER2-positive breast cancer who had not previously undergone chemotherapy for metastatic disease. The trial demonstrated that the combination therapy extended median progression-free survival to 40.7 months, compared with 26.9 months observed in patients receiving standard treatment.

Additionally, tumors shrank or disappeared in 87 percent of participants treated with Enhertu and Perjeta, versus 81 percent in the standard treatment group.

Overall survival results remain immature, as only 16 percent of patients across both arms had passed away at the time of data analysis.

This expanded indication positions the combination as an earlier treatment option, potentially offering improved outcomes for patients diagnosed with this aggressive form of breast cancer. The targeted mechanism of Enhertu continues to represent an important advancement in precision oncology approaches.

AstraZeneca and Daiichi Sankyo collaborate on Enhertu's global development and commercialization, while Roche maintains its established role in HER2-directed therapies through products like Perjeta.

The regulatory decision reflects ongoing progress in refining treatment strategies for HER2-positive metastatic breast cancer, where sequential therapies have traditionally been employed. By moving the Enhertu-based regimen to first-line use, physicians gain an additional evidence-based choice supported by substantial clinical benefits in delaying disease progression.

Patient selection through validated diagnostic testing ensures appropriate application of the therapy, maximizing potential advantages while managing associated considerations.