What's Happening?
Krystal Biotech has decided to discontinue its Phase I/II study of KB707, an investigational intratumoral therapy for melanoma, due to uncertainty surrounding FDA approval pathways. This decision follows the FDA's recent rejection of Replimune's RP1, a similar immunotherapy using modified herpes simplex virus vectors. Krystal suspended enrollment in the OPAL-1 study but continues to monitor dosed patients for safety and efficacy. The FDA's rejection of RP1 was controversial, with agency reviewers overruled by Richard Pazdur, director of the FDA's Oncology Center of Excellence. Scientists involved in Replimune's Phase III trial have urged the FDA to reconsider its decision, arguing that the trial's patient population accurately reflects real-world scenarios.
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Why It's Important?
The suspension of the KB707 study highlights the challenges faced by biotech companies in navigating FDA approval processes, particularly for innovative therapies like viral immunotherapy. The FDA's decision impacts Krystal's development plans and raises questions about the agency's criteria for accelerated approval. The controversy surrounding RP1's rejection underscores the tension between regulatory bodies and scientific experts, potentially affecting future drug development and approval strategies. Krystal's shift in focus to an inhaled version of KB707 for non-small cell lung cancer reflects the company's adaptability in response to regulatory hurdles.
What's Next?
Krystal Biotech is now focusing on developing an inhaled version of KB707 for non-small cell lung cancer, with promising early results showing a 36% objective response rate. The company has scheduled an End of Phase II meeting with the FDA in October to discuss potential pathways for advancing this candidate. The outcome of this meeting will be crucial for Krystal's future development plans and could influence the biotech industry's approach to regulatory challenges.
