Krystal Biotech Receives FDA Fast Track Designation for Inhaled Oncology Candidate KB707 to Treat Solid Tumors of the Lung
PITTSBURGH, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today 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 therapeutic benefits of cytokine therapy for the treatment of solid tumors have long been recognized, but difficult to harness due to toxicities when given systemically.
- In January 2024, the FDA cleared an amendment to the Company’s Investigational New Drug application to evaluate inhaled KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors of the lung.
- In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-programmed cell death protein-1 relapsed/refractory locally advanced or metastatic melanoma.
- “We look forward to the first patient being dosed with inhaled KB707 later this year.”