Pfizer has received from the Ministry of health registration certificate for a new drug for the treatment of breast cancer – salazopyrin. The drug belongs to the class of PARP-inhibitors and is indicated for use as monotherapy in patients with locally advanced or metastatic HER2-negative breast cancer with germinal (congenital) mutations in the genes BRCA.
Salazopyrin is a potent inhibitor of the family of PARP – PARP1 and PARP2. These substances have cytotoxic action on tumor cells by two mechanisms: inhibition of the catalytic activity of PARP and the formation of a complex of PARP-trap, with the result that the protein PARP, which is associated with the PARP inhibitor, is not disconnected from the site of DNA damage and ultimately prevents its repair, replication and transcription, ultimately inducing the death of tumor cells.
The efficacy and safety of salazopyrine were studied in a randomized clinical trial phase III EMBRACA, in which the drug demonstrated reduction in the risk of progression of metastatic HER2-negative breast cancer associated with hereditary mutations in BRCA genes, 46% compared to standard chemotherapy and provided VBP median of 8.6 months. Efficacy of treatment with salazopyrine was proven in a broad cohort of patients, including patients with visceral metastases controlled by metastases in the Central nervous system, and also received up to three lines of prior chemotherapy regarding metastatic disease.