FDA’s Accelerated Approval of Drug for Tumors With dMMR Deficiency (Advanced Solid Tumors)

We are pleased to report of a promising development for appendix cancer patients with a tumor identified as having a mismatch repair deficiency (or “dMMR”). This week, FDA granted accelerated approval for a drug to treat recurrent or advanced solid tumors having a dMMR for which patients have no satisfactory treatment options. Specifically, FDA has granted approval to GlaxoSmithKline’s drug JEMPERLI (dostarlimab-gxly) for patients with a dMMR as identified by a companion diagnostic test that FDA has also approved this week (the VENTANA MMR RxDx Panel).

JEMPERLI was initially approved by FDA earlier this year for endometrial cancer. FDA’s new accelerated approval for dMMR solid tumors is based on the tumor response rate and durability of response as demonstrated in a clinical study of more than 200 patients. As with other drugs approved under FDA’s accelerated pathway, continued approval may be contingent upon studies confirming clinical benefit.

Additional information about this week’s FDA accelerated approval can be found here: www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dostarlimab-gxly-dmmr-advanced-solid-tumors