Function and indication:
Cedabendine tablets are suitable for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who have received at least one systemic chemotherapy in the past. This indication is conditionally approved based on the objective response rate results of a single-arm clinical trial. The long-term survival benefits of this product have not yet been confirmed, and a randomized controlled confirmatory clinical trial is underway.
Adverse reactions:
The safety data of single-agent cedabendine tablets in PTCL patients are mainly derived from a pivotal, single-arm, open, Phase II clinical trial (n=83) and an exploratory, single-arm, open, Phase II clinical trial (n=19). In the pivotal Phase II clinical trial of PTCL, patients were given a dose of 30 mg twice a week, with an average treatment time of 4.4 months (range:
Contraindications:
This product is contraindicated in patients who are allergic to cedabendine or any of its components, pregnant women, and patients with severe heart failure [New York Heart Association (NYHA) heart failure grade IV].
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