The CHMP recommends Enhertu (trastuzumab deruxtecan) for a new indication to include treatment of advanced HER2-mutant non-small cell lung cancer (NSCLC).
On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Enhertu (marketing authorisation holder: Daiichi Sankyo Europe GmbH).
The CHMP adopted a new indication to include treatment of advanced HER2-mutant non-small cell lung cancer (NSCLC).
The full indications for Enhertu will be as follows (new text in bold):
HER2-positive breast cancer => Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
HER2-low breast cancer => Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).
Non-small cell lung cancer (NSCLC) => Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
Gastric cancer => Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.