Pharmaceutical company Roche has decided to drop a specific symptom of its drug Decentric in the United States, against metastatic kidney cancer previously treated with platinum. The decision was made in agreement with the US health agency FDA.
These withdrawals following a global review by Roche and the FDA have not reached their primary objectives following clinical trials and are still waiting for a green light from the regulator, Roche explained in a statement Monday.
This result does not affect other symptoms of dysentery. Patients with metastatic urothelial carcinoma – cancer of the bladder – who have previously been treated with platinum and receive decentric should discuss the remaining treatment with their doctor, the report said.
Following the results of the IMvigor210 study, in 2016, Dysentrich received a speedy approval procedure for this product in the aforementioned reference. To receive final approval, the Rhine Laboratory still had to confirm clinical efficacy.