PIRTOBRUTINIB TAB
Clinical Criteria Summary
Document 675
Indications & Patient Population
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL)
- Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Prior Therapy Requirements
- MCL: At least two lines of systemic therapy, including a BTK inhibitor
- CLL/SLL: At least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Dosing & Administration
- Recommended dosage: 200 mg once daily, with or without food
- Duration: Until disease progression or unacceptable toxicity
- Available tablet strengths: 50 mg, 100 mg
Renal Impairment
- Dose reduction recommended for renal dysfunction
- Reduce dose by 50% for eGFR 15 to 29 ml/min/1.73m2 to a minimum dose of 50 mg daily
Safety & Monitoring Precautions
- Infections: Monitor for signs and symptoms; consider prophylaxis for patients at increased risk, including opportunistic pathogens
- Hemorrhage: Monitor for signs of bleeding; consider risk versus benefit of concurrent antithrombotic agents
- Cytopenias: Monitor/manage neutropenia, thrombocytopenia, and anemia
- Cardiac Arrhythmias: Monitor for signs and symptoms; concurrent cardiac risk factors (e.g., hypertension or history of arrhythmias) may increase risk
- Second Primary Malignancy: Advise patients to wear sunscreen; monitor for development
- Hepatotoxicity: Evaluate liver function tests at baseline and throughout treatment; permanently discontinue for hepatotoxicity or hold if suspected
- Embryo-Fetal Toxicity: Recommend effective contraception during treatment and for one week after the last dose in females of reproductive potential
- Breastfeeding: Advise patients to avoid breastfeeding while taking pirtobrutinib and through 1 week after the last dose
- Older Adults: Higher rates of grade ≥3 adverse effects observed in patients aged ≥65 years
Document 676
Exclusion Criteria
- Patient has not been screened for Hepatitis B Virus (HBV)
- Unmanageable drug-drug or drug-food interaction identified
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (NYHA Class 3 or 4), or myocardial infarction in prior 6 months
- Current or history of central nervous system (CNS) lymphoma
- Active or uncontrolled infection
- Pregnancy
- Lactating
Inclusion Criteria (Indications & Prior Therapy)
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor
- Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Additional Inclusion Criteria (Reproductive Health & Counseling)
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 week after stopping treatment
- Advise patients not to breastfeed and/or provide breastmilk to an infant during treatment and for at least 1 weeks after the last dose
Additional Inclusion Criteria (Performance Status, Provider, & Care Planning)
- Eastern Cooperative Oncology Group Performance Status 0-2
- Care provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented