The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission approved Keytruda (pembrolizumab), an anti-PD-1 therapy, as a monotherapy for the treatment of resectable locally advanced head-and-neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score ≥1.
