HENLIUS's patritumab deruxtecan has been granted FDA approval for the treatment of breast cancer

HENLIUS (02696.HK) announced that it recently received an approval letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) of POHERDY (pertuzumab) 420mg/14mL (30mg/mL) injection, which is a trademark registered in the United States by N.V. Organon.

The approved indications are for use in combination with trastuzumab and docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC) who have not previously received anti-HER2 treatment or chemotherapy for metastatic disease; in combination with trastuzumab and chemotherapy as part of a comprehensive treatment regimen for adult patients with HER2-positive locally advanced, inflammatory, or early breast cancer as neoadjuvant therapy; and for adjuvant treatment in adult patients with HER2-positive early breast cancer at high risk of recurrence.

After the approval of POHERDY for market launch, the group has cumulatively obtained approvals for seven products overseas, four of which have been approved for marketing in the United States