FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic CRC
“This designation is an important validation of our focus on pelareorep’s potential as a platform immunotherapy for gastrointestinal cancers like colorectal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate in a market that is estimated to be worth several billion dollars. Pelareorep offers the potential to help a meaningful number of patients, and I look forward to continuing to collaborate with the FDA to address this treatment gap as expeditiously as possible.”
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