The European Medicines Agency accepted for regulatory review Astellas Pharma’s marketing authorization application for zolbetuximab, an investigational claudin 18.2-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2-positive.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radioligand therapy, in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen-positive, metastatic, castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane based chemotherapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Lynparza (olaparib) for the adjuvant treatment of patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
A committee of the European Medicines Agency recommended the approval for expanded use of Keytruda (pembrolizumab) as a standalone therapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma who have undergone complete resection.
