Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals.
On September 20, 2021, the FDA approved tisotumab vedotin-tftv (brand name Tivdak), 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. 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.
The main efficacy outcome measures were confirmed objective response rate as assessed by an independent review committee using RECIST 1.1 and duration of response. The objective response rate was 24% with a median response duration of 8.3 months.
Product labeling includes a boxed warning for ocular toxicity.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
On September 22, 2021, the FDA approved ruxolitinib (brand name Jakafi) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Efficacy was evaluated in REACH-3, a randomized, open-label, multicenter clinical trial of ruxolitinib compared to best available therapy for corticosteroid-refractory chronic graft-versus-host disease after allogeneic stem cell transplantation. The trial randomized 329 patients 1:1 to receive either ruxolitinib or best available therapy.
The major efficacy outcome used to support approval was overall response rate through cycle 7 day 1. The overall response rate was 70% for the ruxolitinib arm and 57% for the best available therapy arm with a difference in response rate of 13%. The median durations of response, calculated from first response to progression, death, or new systemic therapies for chronic graft-versus-host disease, were 4.2 months and 2.1 months for the ruxolitinib and best available therapy arms, respectively. The median times from first response to death or new systemic therapies for chronic graft-versus-host disease were 25 months and 5.6 months for the ruxolitinib and best available therapy arms, respectively.
In chronic graft-versus-host disease, the most common hematologic adverse reactions of ruxolitinib, reported in more than 35% of patients were anemia and thrombocytopenia. The most common nonhematologic adverse reactions reported in more than 20% of patients were infections and viral infection.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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