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# GSK Waits for Inspection to Complete Dostarlimab Review
- URL: https://www.fdaweb.com/gsk-waits-for-inspection-to-complete-dostarlimab-review/
- Published: 2021-01-20T12:00:00.000Z
- Updated: 2026-09-14T16:43:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148490

FDA has deferred a review action on GlaxoSmithKline’s PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufacturing site inspection due to Covid-19 concerns. The company is telling several media outlets that while the site inspection has not occurred yet, it is working with FDA to schedule the inspection, and that approval is expected in the first half of the year.

FDA review delays appear to be an unwelcome challenge during the Covid-19 pandemic, causing the agency to be more creative in how it can assess a company’s manufacturing facility. A Bristol-Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), indicated for treating relapsed or refractory large B-cell lymphoma, also missed its user fee review action due to a delayed inspection at third-party manufacturer Lonza. However, earlier this month the company noted that the inspection was completed in December and the review was proceeding ([see story](https://www.fdaweb.com/fda-inspection-releases-review-hold-on-bms-liso-cel/)).

Inspection delays affecting application reviews have led to FDA to explore use of “remote regulatory assessments” in lieu of conducting physical facility inspections during the Covid-19 emergency, according to CDER Office of Compliance director **Donald Ashley**. Speaking during a virtual Food and Drug Law Institute conference 12/16/2020 ([see story](https://www.fdaweb.com/cder-increases-remote-regulatory-assessments/)), Ashley discussed how CDER has adapted to the changing times by increasing its use of alternative tools to conduct oversight and take regulatory actions, such as sampling of drugs, relying on information shared by its foreign regulatory partners, requesting records and other information from drug manufacturers, clinical investigators and any other parties that are normally subject to inspection, and remote regulatory assessments.