2023-04-17 08:21:48 ET
Agenus ( NASDAQ: AGEN ) announced Monday that the FDA granted Fast Track Designation for a combination therapy containing its anti-CTLA-4 compound botensilimab (AGEN1181) and anti-PD-1 molecule balstilimab (AGEN2034) as a treatment for certain colorectal cancer.
Specifically, the designation covers the treatment’s application for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer whose disease has not impacted their liver.
The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
If certain criteria are met, such programs will also be able to win Accelerated Approval and Priority Review, enabling patients to access those treatments sooner.
Agenus ( AGEN ) is advancing a global Phase 2 trial to compare botensilimab and balstilimab against the standard of care in high non-MSI-H colorectal cancer. A global Phase 3 trial for the combination in non-MSI-H CRC is also expected to start in 2023.
According to Seeking Alpha analyst William Meyers, the company “is likely to have the most effective CTLA-4 agent on the market in 2024 or 2025.”
For further details see:
Agenus wins FDA fast track tag for colorectal cancer therapy