TAZEMETOSTAT TAB NEW
Clinical Criteria Summary
Document 348
Exclusion Criteria
- Positive Hepatitis B surface antigen with abnormal LFTs (Tbili >1.5x Upper Limit of Normal and/or Alk phos, ALT and AST > 3x Upper Limit of Normal or > 5x Upper Limit of Normal if liver metastasis)
- Positive Hepatitis C Virus RNA with abnormal LFTs (Tbili > 1.5x Upper Limit of Normal and/or Alk phos, ALT and AST > 3x Upper Limit of Normal or > 5x Upper Limit of Normal if liver metastasis)
- Unmanageable drug or food interaction
- Unable to take oral medications due to malabsorption syndrome or other gastrointestinal syndrome
- Inclusion Criteria (One must be met)
- Metastatic or locally advanced epithelioid sarcoma, not eligible for complete resection
- Relapsed or refractory follicular lymphoma, with an EZH2 mutation and received at least 2 prior systemic therapies
- Relapsed or refractory follicular lymphoma, who have exhausted all treatment options
- Additional Inclusion Criteria (General & Performance) (All must be met)
- Care for the oncologic condition provided by VA or VA Community Care oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance status 0-2
- Additional Inclusion Criteria (Reproductive & Contraception) (All must be met)
- For patients who can become pregnant: Pregnancy must be excluded prior to receiving tazemetostat
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 6 months after stopping treatment
- For 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 at least 3 months after stopping treatment
- Advise patients not to breastfeed during treatment and for 7 months following the last dose
Document 363
Indications
- • Metastatic or locally advanced epithelioid sarcoma, not eligible for complete resection
- • Relapsed or refractory follicular lymphoma (FL), with an EZH2 mutation
- • Relapsed or refractory FL without a mutation, but only when no alternative treatment options exist
Patient Selection & Clinical Context
- • Epithelioid sarcoma: Considered a reasonable option to avoid known cumulative toxicities of chemotherapy; chemotherapy may be considered due to slightly improved response rates.
- • Follicular lymphoma: May be considered if an EZH2 mutation is detected after 2 prior therapies. In the relapsed setting with no other reasonable therapeutic alternatives, may be considered regardless of EZH2-mutation status.
Dosing & Administration
- • 200 mg oral tablets
- • 800 mg PO twice daily
Safety Monitoring & Precautions for Use
- • Monitor patients long-term for development of secondary malignancies (T-cell lymphoblastic lymphoma, MDS, AML)
- • Advise use of effective non-hormonal contraception due to embryo-fetal toxicity and potential reduction in efficacy of hormonal contraceptives
- • Avoid concomitant administration with strong and moderate CYP3A inhibitors or inducers; reduce dose if interaction cannot be avoided