Krystal Biotech receives FDA Fast Track Designation for KB707

Krystal Biotech announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation for inhaled KB707 for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy. “The FDA’s decision to grant inhaled KB707 Fast Track Designation is a reflection of both the urgent unmet need that exists for patients with lung metastases and the robust preclinical data we have generated to date in stringent syngeneic mouse models of checkpoint inhibitor refractory metastatic disease,” said Suma Krishnan, President, Research & Development, Krystal Biotech. “We look forward to the first patient being dosed with inhaled KB707 later this year.”