EMA validates Type II Variation MAA for AstraZeneca, Daiichi’s Enhertu

The European Medicines Agency, EMA, has validated the Type II Variation marketing authorization application, MAA, for Enhertu in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. Enhertu was discovered by Daiichi Sankyo (DSNKY) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN). “This validation in the EU is an important step in moving us closer to offering Enhertu in combination with pertuzumab as a potential new first-line treatment option for patients with HER2 positive metastatic breast cancer,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following the recent approval in the U.S. for this indication, we look forward to working closely with the EMA to bring Enhertu to eligible patients in the EU who may benefit from improved outcomes in a setting where the standard of care has not changed in more than a decade.”