Urgent Appeal to Establish Compassionate Use / Pre-Approval Access Program for Ganfeborole (GSK-656)
28 July 2025
Advocates appeal to GSK to establish a compassionate use program for ganfeborole (GSK-656).
On 28 July 2025, the Global Tuberculosis Community Advisory Board (TB CAB) sent an open letter to GSK urging the company to establish a compassionate use / pre-approval access program for ganfeborole.
“As we learned from the development and introduction of bedaquiline, delamanid, and pretomanid, pre-approval access to investigational drugs is crucial for people with extensively drug-resistant TB (XDR-TB) and other complicated forms of resistance, as it provides potentially life-saving treatment to individuals in situations of unmet medical need. Pre-approval access programs can also generate valuable data to inform broader use among populations who might otherwise be excluded from clinical trials.”
With phase 2b studies of ganfeborole underway, now is the time to plan for compassionate use / pre-approval access. In the letter, the TB CAB asks GSK about the company’s internal thinking and how TB CAB advocacy can help progress ongoing discussions and the establishment of a pre-approval access program for ganfeborole for people with XDR-TB and unmet medical need.
The TB CAB requested a written response to the letter by 11 August 2025.
Download the open letter here.