FDA Approvals – August 2021

Several indications and molecules were approved in August by FDA including the following:

1- Lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

2- Belzutifan, a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.

3- Dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. 

4- Nivolumab for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.

5- Ivosidenib for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Check FDA approvals during July 2021.