Faron Announces Positive FDA Feedback Regarding Registration Study Plan in MDS
Current TAP Partner
TURKU, Finland, July 1, 2024 - Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provides information on the result of its formal Type D Scientific Advice Meeting with the USA Food and Drug Administration (the FDA) regarding the registrational study plan for its drug candidate bexmarilimab in relapsed and refractory high risk MDS (r/r MDS).
Key highlights:
- The FDA acknowledged the difficulties of running a randomized study with a comparator in the relapsed / refractory setting (r/r) and instead proposed that Faron conduct a confirmatory Phase III study in frontline high-risk MDS (HR MDS), that would not require a separate Phase III in r/r MDS.
- This FDA guidance is part of Project Frontrunner, an initiative intended to bring promising new cancer treatments as early as possible to a broader patient population.
- The Phase III suggested by the FDA targets a significantly larger patient population with potential for faster approval earlier than anticipated, speeding up and increasing our sales forecast for bexmarilimab.