Posted by Michael Wonder on 09 Feb 2026
Krystal Biotech announces RMAT designation granted by FDA to KB707 for the treatment of advanced or metastatic non-small cell lung cancer
9 February 2026 - Krystal Biotech announced today that the US FDA granted regenerative medicine advanced therapy designation to KB707, the Company’s redosable immunotherapy designed to drive sustained, localised expression of interleukin-2 and interleukin-12 in the tumour microenvironment, for the treatment of advanced or metastatic non-small cell lung cancer.
Data to support the FDA’s designation included early clinical evidence from the Company’s on-going KYANITE-1 study that demonstrated consistent and meaningful anti-tumour activity, including durable responses and clinically significant tumour reductions, in patients with heavily pre-treated advanced non-small cell lung cancer receiving inhaled KB707.
