Access Program for Valemetostat Tosylate for Treating Relapsed or Refractory Peripheral T-cell Lymphoma

Patients are only eligible after signing the Informed Consent Form (ICF) and must meet all of the following criteria to be eligible for the MAP:

1. The patient is ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed.

2. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

3. The treating physician will confirm the following:

   1. 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.

   2. 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.

   3. The patient has an adequate organ function with hepatic and renal function laboratory parameters as specified in the protocol.

   4. The patient has an adequate bone marrow function.

   5. Female patients of childbearing potential agree to use highly effective, low user dependence contraception methods and refrain from donating eggs during treatment and for 3 months after the last dose.

      Note: Monthly at-home pregnancy testing recommended after the last dose of valemetostat tosylate and for 3 months

   6. Male patients capable of producing sperm agree to use highly effective with low user dependence contraception methods and refrain from donating sperm during treatment and for 3 months after the last dose.

Patients who meet any of the following criteria will not be eligible for the MAP:

1. The patient is eligible and can participate in a clinical trial involving an investigational medicine that may potentially treat the condition (s) indicated in this program and/or the patient may be treated and benefit from approved drugs available for the treatment of the condition(s) indicated in this program.
2. The patient has a diagnosis of mycosis fungoides, Sézary syndrome, and primary cutaneous ALCL and systemic dissemination of primary cutaneous ALCL.
3. The patient has a diagnosis of precursor T-cell leukemia and lymphoma (T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma), T-cell prolymphocytic leukemia, or T-cell large granular lymphocytic leukemia.
4. The patient has undergone a transplant and has not yet recovered, as determined at the discretion of the treating HCP.
5. The patient has an uncontrolled or significant cardiovascular disease.
6. Patients who are pregnant or breastfeeding or intend to become pregnant during the program.
7. The patient shows evidence of ongoing uncontrolled acute systemic bacterial, fungal, or viral infection i.e. HIV, Hepatitis B&C requiring systemic therapy.
8. The patient has any active uncontrolled systemic diseases or other medical conditions considered to be poorly controlled by the healthcare provider, including, but not limited to, bleeding diatheses.
9. The patient has a known or suspected hypersensitivity to valemetostat tosylate or any of the excipients.