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

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

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  • 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

  Ref: PR Newswire | Image: GSK

Click here to­ read the full press release 

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