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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 2 days ago
- 1 min read
09/02/2026
Krystal Biotech's KB707 received the FDA RMAT Designation for advanced or metastatic NSCLC (Ref)
The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Krystal Biotec's KB707 (redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 and interleukin-12 in the tumor microenvironment) for the treatment of advanced or metastatic NSCLC.
Suma Krishnan, President of Research and Development, Krystal Biotech: “The FDA’s decision to grant RMAT designation to KB707 reflects both the urgent unmet need for new NSCLC therapies as well as the promising early clinical evidence of efficacy we have observed with inhaled KB707 in patients with advanced NSCLC. “This is the second RMAT designation granted to a Krystal program and, as such, we know first-hand the benefits that this designation can provide to accelerate development and shorten the path to a potential approval. We are excited to work closely with the FDA to maximize the potential impact of our KB707 program for patients with NSCLC.”
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