Jemperli (dostarlimab) Approved in the U.S. as First and Only Immunotherapy for Adults with MSI-H/dMMR Locally Advanced Rectal Cancer
GSK received FDA approval for Jemperli (dostarlimab) as the first and only immunotherapy for adults with MSI-H/dMMR locally advanced rectal cancer -- a new indication for the antibody discovered by AnaptysBio. AnaptysBio holds royalty rights to Jemperli, so each approval expands the product's addressable market and ANAB's future royalty stream, even though GSK books the sales.
Key figures
- Drug Name
- Jemperli (dostarlimab)
- Phase Of Trial
- AZUR-1 pivotal trial (interim analysis)
- Pdufa date
- February 2027 (approval ahead of PDUFA date)
- Ccr12 central review
- 47% (54/116)
- Serious adverse reactions
- 20%
- Ccr12 investigator assessed
- 68% (98/144)
- Msi h rectal cancer prevalence
- 5-10% of rectal cancers
- No evidence of cancer 1yr plus
- 76% (110/144)
AI analysis
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