PharmaMar receives FDA clearance for the PM54 platform trial STARFISH-54 to accelerate combination development across solid tumors

The platform trial named STARFISH-54 is designed to facilitate faster addition of new combinations involving PharmaMar’s PM54 within a common framework. The first two cleared sub-studies will evaluate PM54 with irinotecan and with doxorubicin in various solid tumors. This milestone reinforces PharmaMar’s strategy and broad development for PM54. PharmaMar (MSE: PHM) has announced that the American Food and Drug Administration (FDA) has provided clearance for platform trial STARFISH-54 for PM54 to evaluate its activity in various solid tumors in combination with other therapies. The first authorizations are for PM54 in combination with irinotecan and PM54 in combination with doxorubicin. The platform trial is designed under a common protocol to evaluate multiple combinations simultaneously of PM54 with other agents, while providing flexibility to add new treatment cohorts as scientific evidence emerges for faster results and clearance for new trial approvals. “This milestone reflects our commitment to deliver meaningful innovation for patients by accelerating the clinical development of PM54. The platform’s flexible design enables us to evaluate new combinations more efficiently, with the ultimate goal of bringing potential new treatment options to patients with significant unmet medical needs”, commented Javier Jiménez, Chief Medical Officer at PharmaMar.

The release as fetched from its publisher. pharmamar.com ↗