CHMP recommends Tivdak (tisotumab vedotin) to treat recurrent or metastatic cervical cancer – Pfizer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Tivdak, ( tisotumab vedotin) intended for the treatment of recurrent or metastatic cervical cancer. The applicant for this medicinal product is Pfizer Europe MA EEIG. Tivdak will be available as a 40 mg powder for concentrate for solution for infusion. The active substance of Tivdak is tisotumab vedotin, an antineoplastic agent (L01FX23). Tisotumab vedotin is an antibody-drug conjugate that binds to tissue factor (TF)‑expressing tumour cells, causing the product to enter the cells. Upon internalisation, monomethyl auristatin E is released and disrupts the microtubule network of actively dividing cells, leading to cell death.

The benefits of Tivdak are its superiority in terms of prolonging survival and survival without disease progression compared to chemotherapy, as shown in a phase III randomised open-label study in patients with recurrent or metastatic cervical cancer treated in second or third line of therapy. The most common side effects are peripheral neuropathy, nausea, epistaxis, conjunctivitis, alopecia, anaemia and diarrhoea.