GSK’s Jemperli (dostarlimab-gxly) Receives the US FDA’s Accelerated Approval for the Treatment of dMMR Recurrent or Advanced Solid Tumors

August 18, 2021 Auto Bot regulatory 0

Shots:

  • The approval is based on the results from cohort A1 & F of the ongoing P-I GARNET trial evaluates dostarlimab (500mg, IV, q3w for 4 doses) as monothx. in 209 patients with dMMR solid tumors, including EC & non-endometrial cancer. The therapy was discovered by AnaptysBio & licensed to Tesaro
  • Results: In all dMMR solid tumor, ORR (41.6%); CR rate (9.1%); PR rate (32.5%), m-DoR (34.7 mos.), 95.4% of patients maintain response for >6mos. Additionally, patients with non-endometrial cancer demonstrated an ORR (38.7%)
  • The approval follows an FDA priority review of BLA. The therapy marks 2nd indication & is currently being evaluated in other studies as monothx. or in combination for other cancers

Click here to­ read full press release/ article | Ref: PR Newswire | Image: The Economic Times

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