Earlier this month the FDA approved a new Infused therapy, Tivdak (tisotumab vedotin-tftv) from Seagen Inc., for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak is expected to meet the unmet needs of patients with recurrent or metastatic cervical cancer.
Tivdak is a first-in-class antibody-drug conjugate (ADC) that targets tissue factor to induce cancer cell death. The labeling for Tivdak included a boxed warning related to ocular toxicity.
The wholesale acquisition cost (WAC) for Tivdak is $5,885 per 40mg single dose vial. Patient cost is dependent on body weight and duration of therapy. The company estimates an average WAC per patient per month of $34,000, before discounts or rebates. Distribution details were not announced as of this date.
FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
On September 20, 2021, the Food and Drug Administration granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Approval was based on innovaTV 204, an open-label, multicenter, single-arm clinical trial (NCT03438396). Efficacy was evaluated in 101 patients with recurrent or metastatic cervical cancer who had received no more than two prior systemic regimens in the recurrent or metastatic setting, including at least one prior platinum-based chemotherapy regimen. Sixty-nine percent of patients had received bevacizumab as part of prior systemic therapy. Patients received tisotumab vedotin-tftv 2 mg/kg every 3 weeks until disease progression or unacceptable toxicity.
The main efficacy outcome measures were confirmed objective response rate (ORR) as assessed by an independent review committee (IRC) using RECIST v1.1 and duration of response (DOR). The ORR was 24% (95% CI: 15.9%, 33.3%) with a median response duration of 8.3 months (95% CI: 4.2, not reached).
The most common adverse reactions (≥25%), including laboratory abnormalities, were hemoglobin decreased, fatigue, lymphocytes decreased, nausea, peripheral neuropathy, alopecia, epistaxis, conjunctival adverse reactions, hemorrhage, leukocytes decreased, creatinine increased, dry eye, prothrombin international normalized ratio increased, activated partial thromboplastin time prolonged, diarrhea, and rash. Product labeling includes a boxed warning for ocular toxicity.
The recommended dose is 2 mg/kg (up to a maximum of 200 mg for patients ≥100 kg) given as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
This application was granted priority review. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.