This approval marks a significant milestone as TIVDAK becomes the first antibody-drug conjugate (ADC) with proven overall survival data to receive such endorsement in this patient group.
The FDA’s decision is a conversion from the accelerated approval granted in September 2021 to full approval .
TIVDAK application received priority review designation, which is reserved for medicines that potentially offer significant treatment advances or fill an unmet medical need.
As per the announcement, the full approval is based on the outcomes of the global, randomised, Phase III innovaTV 301 clinical trial.
During the trial, TIVDAK demonstrated a primary endpoint achievement of overall survival (OS) in patients with previously treated recurrent or metastatic cervical cancer, outperforming chemotherapy.
The innovaTV 301 study showcased a 30% reduction in the risk of death when compared to chemotherapy, with a median OS of 11.5 months for patients treated with TIVDAK, against 9.5 months for those on chemotherapy.
Secondary endpoints of a confirmed objective response rate (ORR) and progression-free survival (PFS) were also successfully met.
Despite the positive efficacy outcomes, the treatment does come with side effects.
The most common adverse reactions and laboratory abnormalities in patients receiving TIVDAK, occurring in 25% or more cases, included decreased haemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation.
Genmab CEO Jan van de Winkel said: “The full FDA approval of TIVDAK represents a significant achievement for women with recurrent and metastatic cervical cancer, reinforcing TIVDAK as a treatment option that has proven to extend survival in patients whose disease has advanced after initial treatments.
“This milestone underscores the importance of our ongoing clinical development program to assess the full potential of tisotumab vedotin as a treatment option in other indications.”