EU approves Astrazeneca's Enhertu for HER2 positive metastatic solid tumors
- Enhertu (trastuzumab deruxtecan) has been approved in the European Union as a monotherapy for unresectable or metastatic HER2 positive (IHC 3+) solid tumors in adults who have received prior treatment with no satisfactory alternatives.
- This marks the first tumor-agnostic approval for a HER2-directed therapy in the EU.
- The approval is based on results from the DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials showing meaningful response rates across multiple tumor types.
Daiichi Sankyo and AstraZeneca (NASDAQ:AZN) announced that Enhertu (trastuzumab deruxtecan) has been approved in the European Union as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior treatment and who have no satisfactory alternative treatment options.
Enhertu is a specifically engineered HER2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from subgroups of patients with HER2 positive tumors across three Phase 2 trials.
In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate of 52.3% and median duration of response of 21.1 months in previously treated patients with HER2 positive solid tumors.
This approval expands Enhertu’s indications in the EU and establishes it as the first tumor-agnostic HER2-directed therapy in the region.
Daiichi Sankyo will receive a $25 million milestone payment from AstraZeneca following this approval.
Sales of Enhertu in most EU territories are recognized by Daiichi Sankyo.
Enhertu (5.4 mg/kg) is now approved in more than 40 countries for various indications, with additional regulatory submissions ongoing in the EU and other regions.
