Business
FDA Grants Accelerated Approval of JEMPERLI (dostarlimab-gxly) for dMMR Recurrent or Advanced Solid Tumors
Second FDA Approval of PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in Collaboration with GSKJEMPERLI Was Approved For dMMR
About this update from Anaptysbio, Inc.
[{"type":"text","content":"Second FDA Approval of PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in Collaboration with GSKJEMPERLI Was Approved For dMMR Endometrial Cancer in the US and Europe in April 2021$20MM Milestone Payment Earned by AnaptysBio Upon Second JEMPERLI FDA Approval in Addition to $40MM Already Earned Upon Prior Regulatory Milestones During 2021Additional $15MM and $165MM Milestones Due Upon Achievement of JEMPERLI Regulatory and Commercial Milestones, RespectivelyAnaptysBio Due to Receive 8% to 25% Royalty on Global Net Sales of JEMPERLI SAN DIEGO, Aug. 17, 2021 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that the U.S. Food and Drug Administration (FDA) approved a second indication for GSK’s JEMPERLI (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. JEMPERLI was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. Eight AnaptysBio-generated therapeutic antibodies have advanced into clinical development to date. JEMPERLI is the first AnaptysBio-generated antibody to obtain FDA approval, and this is the second indication for JEMPERLI to be approved by the FDA in 2021. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). “We are pleased that JEMPERLI has been FDA-approved for a second indication and will be available to a broader cohort of solid tumor patients,” said Hamza Suria, president and chief executive officer of AnaptysBio. “AnaptysBio’s capital-efficient business model is focused upon advancing our wholly-owned first-in-class antibodies to multiple clinical catalysts over the upcoming 18 months and is supported by milestone and royalt...