GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: The US FDA has accepted the sBLA under Project Orbis & granted priority review to Jemperli in previously untreated stage II/III dMMR/MSI-H locally advanced rectal cancer (PDUFA: Feb 2027), with eligibility for an earlier decision through the NPV program sBLA was based on the global P-II (AZUR-1) trial assessing Jemperli (dostarlimab) monotx. (500mg, IV, Q3W…

ByRidhi RastogiAugust 25, 2026

NEWS

GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer

Shots: GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…

ByRidhi RastogiJuly 13, 2026

NEWS

Tesaro (GSK) Licenses Alteogen’s ALT-B4 to Develop & Commercialize SC Formulation of Dostarlimab

Shots: Tesaro (GSK’s subsidiary) has entered into an exclusive license agreement to use Alteogen’s ALT-B4 for the development & commercialization of a SC formulation of dostarlimab As per the deal, Alteogen will be responsible for clinical and commercial supply of ALT-B4 to Tesaro, in exchange for $20M upfront & ~$265M in development, regulatory & sales milestones,…

ByRidhi RastogiJanuary 20, 2026

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2023

Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

BySenior EditorAugust 16, 2023

THOUGHTSPOT

A ray of hope? Cancer Disappeared Unanticipatedly in Every Patients

Today one news that is breaking on the internet. A small drug trial conducted in MSKCC, US observed every patient in the study had their cancer successfully go into complete remission. Despite the fact that the study is modest, it provides a glimpse of hope to those who are suffering from this fatal disease. A…

BySenior EditorJune 8, 2022

GSK’s Jemperli (Dostarlimab) Secures US FDA Priority Review for dMMR/MSI-H Locally Advanced Rectal Cancer

GSK Reports P-II (AZUR-1) Trial Data on Jemperli for dMMR/MSI-H Locally Advanced Rectal Cancer

Tesaro (GSK) Licenses Alteogen’s ALT-B4 to Develop & Commercialize SC Formulation of Dostarlimab

Insights+: The US FDA New Drug Approvals in July 2023

A ray of hope? Cancer Disappeared Unanticipatedly in Every Patients

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