Vientiane, Laos, August 01, 2024 – BigBear Pharma, a leading biopharmaceutical company focused on developing and commercializing innovative cancer treatments, announced that Tazemetostat oral tablets have been approved by the Lao Ministry of Health. It will be marketed under the brand name TAZEDX. Lao registration number: Lao Reg No.: 07L1139/24.
Tazemetostat is an inhibitor of the histone-lysine N-methyltransferase EZH2. By inhibiting EZH2, it suppresses the methylation of histone H3 lysine 27 (H3K27), restores the expression of tumor suppressor genes, allows B cells to continue differentiation or induces cytotoxicity, thereby controlling tumor growth.
Indications
1. Epithelioid Sarcoma
For the treatment of metastatic or locally advanced epithelioid sarcoma (not amenable to complete resection) in adult and adolescent patients aged 16 years and older.
2. Follicular Lymphoma
For the treatment of adult patients with relapsed or refractory follicular lymphoma whose tumors have EZH2 mutations (at positions Y646, A682, or A692) as detected by an FDA-approved test, who have received at least two prior systemic therapies.
Dosage and Administration
1. Oral administration, 800 mg twice daily. The two doses should be taken approximately 12 hours apart.
2. Patients may take the medication with or without food, but should be consistent with each dose.
3. The tablet should be swallowed whole. Do not break, crush, or chew the tablet, as this may affect efficacy.
Adverse Reactions
Epithelioid Sarcoma
Common adverse reactions (≥20%) include pain, fatigue, nausea, decreased appetite, vomiting, constipation, anemia, lymphopenia.
Follicular Lymphoma
Common adverse reactions (≥20%) include fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, abdominal pain, lymphopenia, hyperglycemia, leukopenia, neutropenia, thrombocytopenia, anemia.
Serious Risks
May cause cytopenias (increasing risk of infection and bleeding), interstitial lung disease, fetal toxicity, and second primary malignancies.
Warnings and Precautions
Secondary Malignancies
Tazemetostat increases the risk of developing secondary malignancies, including T-cell lymphoblastic lymphoma, myelodysplastic syndrome, and acute myeloid leukemia. Monitor patients long-term for the development of secondary malignancies.
Embryo-Fetal Toxicity
Can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective non-hormonal contraception.
