GLAXOSMITHKLINE — Jemperli FDA Review (NDA/BLA 761174, 2026)
GSK plc · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
JEMPERLI (dostarlimab-gxly) received FDA approval on July 31, 2023, for endometrial cancer and other dMMR solid tumors. Approved indications include dMMR/MSI-H recurrent or advanced endometrial cancer (monotherapy) and primary advanced or recurrent dMMR/MSI-H endometrial cancer (in combination with chemotherapy). Clinical trials, including RUBY and GARNET, demonstrated significant improvements in progression-free survival and objective response rates. The safety profile highlights immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies) and other common side effects. Dosage guidelines for monotherapy and combination regimens are provided, along with postmarketing commitments for further data. Pharmacokinetic parameters and detailed safety data, including adverse events leading to discontinuation, are also outlined.
Key findings — cited to the page
| Grade 2 adrenal insufficiency incidence | 0.5 % | · p.17 |
| Grade 2 hyperthyroidism incidence (JEMPERLI single agent) | 2.1 % | · p.19 |
| Grade 3 pneumonitis incidence | 0.8 % | · p.17 |
| Grade 3 colitis incidence | 0.7 % | · p.17 |
| Grade 2 hyperthyroidism incidence (JEMPERLI + carboplatin + paclitaxel) | 2.9 % | · p.18 |
| Grade 3 hyperthyroidism incidence (JEMPERLI + carboplatin + paclitaxel) | 0.4 % | · p.18 |
| Grade 2 colitis incidence | 0.7 % | · p.17 |
| Grade 2 pneumonitis incidence | 1.3 % | · p.17 |
| Grade 3 hepatitis incidence | 100 % | · p.17 |
| Grade 4 pneumonitis incidence | 0.2 % | · p.17 |
| Grade 3 adrenal insufficiency incidence | 0.7 % | · p.17 |
| Grade 3 hyperthyroidism incidence (JEMPERLI single agent) | 0.2 % | · p.19 |
Source: GSK plc ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →