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FDA today accelerates approval of GlaxoSmithKline PD-1 antibody to treat specific solid tumors

 Last Update: 2021-08-27
 Source: Internet
 Author: User

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Today, GlaxoSmithKline (GSK) announced that the US FDA has accelerated the approval of the company’s PD-1 antibody Jemperli (dostarlimab-gxly) for extended indications for the treatment of relapsed or advanced stages with mismatch repair defects (dMMR) Patients with solid tumors

Mismatch repair defective tumor cells affect the normal repair of DNA damage during DNA replication

This approval is based on the results of a clinical trial called GARNET

Reference materials:

[1] FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors.

[2] GSK receives FDA accelerated approval for JEMPERLI (dostarlimab-gxly) for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.

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