Source: Pharmaceutical Technology
Genmab-Pfizer’s cervical cancer treatment is under EMA review. Credit: Jo Panuwat D / Shutterstock.com. The antibody-drug conjugate (ADC) would become the first treatment option in the European Union for adult cervical cancer patients whose disease has advanced on or following systemic therapy. The MAA submission is based on results from the randomised, international Phase III innovaTV 301 trial.
Tisotumab vedotin demonstrated improved overall survival, progression-free survival and objective response rates. Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
The findings are compared to those obtained from chemotherapy treatments.
The primary goal of the study was to assess overall survival, while secondary outcomes included progression-free survival and quality-of-life measures.
Data from the innovaTV 204 Phase II single-arm trial of tisotumab vedotin monotherapy was also included in the application. The safety profile observed in the innovaTV 301 trial aligns with the known safety information provided in the US prescribing details.
“There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potentially improved outcomes to women diagnosed with this devastating disease.”
“We remain dedicated to collaborating closely with regulatory authorities, while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.”