Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Any solid tumor.
The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.
This statement is based on a regulatory approval from the European Medicines Agency:
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.