As the first original new chemical drug approved for marketing in China and the first oral, subtype selective histone deacetylase (HDAC) inhibitor in the world, Sidabenamide can target and regulate the epigenetic abnormalities in hematological malignancies, breast cancer and other solid tumors based on its unique mechanism of action. Sidabenamide has been approved for the treatment of lymphoma and breast cancer, achieving a leap from hematological malignancies to solid tumors.
1、 Indications:
1. Used for recurrent or refractory peripheral T-cell lymphoma (PTCL) patients who have received at least one systemic chemotherapy in the past.
This indication is conditionally approved based on the objective response rate results of a single arm clinical trial. The long-term survival benefits of this product have not been confirmed, and confirmatory clinical trials with randomized controlled designs are currently underway.
2. Combined aromatase inhibitor is used for locally advanced or metastatic breast cancer patients with hormone receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, recurrence or progression after endocrine therapy.
2、 Usage and dosage:
Xidabenzamide tablets are taken orally. It is recommended for adults to take 30mg (6 tablets) each time, twice a week with an interval of no less than 3 days (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), and take 30 minutes after meals.
3、 Adverse reactions:
Hematological adverse reactions: decreased platelet count, decreased white blood cell or neutrophil count, decreased hemoglobin;
Systemic adverse reactions: fatigue, fever:
Gastrointestinal adverse reactions: diarrhea, nausea, and vomiting;
Metabolic and nutritional system adverse reactions: decreased appetite, hypokalemia, and hypocalcemia:
And other adverse reactions, including dizziness, rash, etc.
