Successful pre-BLA meeting with the US FDA to support BLA for RP1 (vusolimogene oderparepvec) in anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024 announced
“This successful pre-BLA meeting confirmed that the accelerated approval path is available for RP1 in anti-PD1 failed melanoma,” said Sushil Patel, Ph.D., Chief Executive Officer at Replimune. “With the confirmatory IGNYTE-3 trial underway, we remain on track to submit the BLA in 2H 2024 and continue our preparations to bring RP1 to patients with advanced melanoma.”
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