Valemetostat tosylate demonstrates antitumour activity in patients with peripheral T-cell lymphomas (PTCL) with a manageable safety profile. This Medical Access Program (MAP) offers an alternative treatment option for patients with PTCL who are ineligible for clinical trials by providing access to valmetostat tosylate, a medicinal product that has received marketing authorisation in Japan.
The patient is ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Patients with the indicated subtypes of PTCL are eligible, according to 2016 World Health Organization classification prior to receiving the first dose of valemetostat tosylate.
The patient must have at least 2 prior lines of systemic therapy for PTCL or ATLL. Patients with ALCL must have prior brentuximab vedotin treatment.
None
Valemetostat tosylate
DrugIn this MAP, the recommended starting dose for eligible patients is 200 mg of valemetostat tosylate once daily in continuous 28-day cycles, to be continued until disease progression or unacceptable toxicity.
Click on the lead sponsor to view all of their trials.
