Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 200 mg) |
Drug Class | Methyltransferase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
- Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
- Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
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Summary
- Tazverik (tazemetostat) is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. It is also indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies. Additionally, it is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Mosunetuzumab vs. Tazemetostat (EZH2 wild-type patients, RR FL): Mosunetuzumab demonstrated superior effectiveness, with better outcomes in Complete Response (CR), Objective Response Rate (ORR), and Progression-Free Survival (PFS) compared to tazemetostat.
- Tazemetostat vs. PI3K Inhibitors (3L/4L+ R/R FL): Tazemetostat exhibited a similar Objective Response Rate (ORR) compared to idelalisib, duvelisib, copanlisib, and umbralisib, indicating no significant difference in effectiveness among these treatments.
- Tazemetostat was associated with a lower relative risk (RR) for all grouped safety outcomes compared to PI3K inhibitors, with specific RRs for grade ≥3 TEAEs being 0.45 (idelalisib), 0.35 (duvelisib), 0.37 (copanlisib), and 0.65 (umbralisib), all statistically significant (p < 0.01).
- Mosunetuzumab demonstrated a more favorable safety profile compared to tazemetostat, with fewer discontinuations due to adverse events.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tazverik (tazemetostat) Prescribing Information. | 2023 | Epizyme Inc., Cambridge, MA |