About the FDA decision in Cervical Cancer
The Food and Drug Administration, the FDA, has granted an accelerated approval to Tivdak (Tisotumab Vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer following disease progression on or after chemotherapy.
The decision from the FDA is supported by data from the single-arm phase 2 innovaTV 204 trial (NCT03438396) of Tivdak which resulted in a 24% confirmed overall response rate by independent review committee in previously treated, recurrent or metastatic cervical cancer.
Overall response rate, ORR, is the percentage of patients whose disease stopped growing plus those whose metastases shrunk between 30-50% in dimensions plus those who reached a complete remission of their disease.
What did the study demonstrate?
Results from the trial that were previously presented at the European Society for Medical Oncology, ESMO, 2020 Virtual Congress highlighted:
- A 7% complete remission rate
- A 17% partial response rate
- A median duration of response was 8.3 months
The application for Tivdak in this indication was submitted in February 2021 to the FDA and granted priority review in April 2021.
Continuous approval may be contingent upon verification from additional clinical data. The phase 3 innovaTV 301 trial (NCT04697628) comparing Tivdak vs investigators choice of chemotherapy in patients with recurrent or metastatic cervical cancer is currently ongoing.
Regarding safety
Tivdak showed a manageable and tolerable safety profile, with no new safety signals identified.
The most common treatment-related side effects with a 10% or higher incidence rate included alopecia (38%), epistaxis (30%), nausea (27%), conjunctivitis (26%), fatigue (24%), dry eye (23%), myalgia (15%), anemia (12%), asthenia (12%), arthralgia (12%), decreased appetite (11%), keratitis (11%), and pruritis (10%).
Most of these were very tolerable, but severe cases occurred in 28% of patients. Of the 4 patients who died, 1 was due to septic shock that was treatment related.
Conclusions
Tivdak may now be used to treat patients with recurrent or metastatic cervical cancer after the FDA’s decision to grant the drug an accelerated approval.
Tivdak’s approval as a monotherapy in the U.S. is an important milestone for women with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, as they need a new treatment option
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