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NEWS
Lantern Pharma Announces Three U.S. FDA Rare Pediatric Disease Designations Granted to LP-184 in Multiple Ultra Rare Children's Cancers
• Lantern Pharma was granted the rare pediatric disease designation (RPDD) for drug-candidate, LP-184, in three cancer indications: Malignant Rhabdoid Tumors, Rhabdomyosarcoma, and Hepatoblastoma.
• This brings the total number of RPDDs for LP-184 to 4, including one previously granted for ATRT (Atypical Teratoid Rhabdoid Tumors).
• Efficacy of LP-184 in these three rare pediatric cancers was demonstrated through evidence of tumor regression and extended event-free survival in specialized models developed as part of the Pediatric Preclinical Testing Program (PPTP), an initiative supported by the National Cancer Institute (NCI) to identify novel therapeutic agents that may have significant activity against childhood cancers.
• Companies with RPDDs might be eligible to receive a Priority Review Voucher (PRV) upon FDA marketing approval that could be redeemed to receive a priority review for any subsequent marketing application. If received, PRVs may be used by the sponsor or sold to another sponsor and have recently sold for over $100 million(1).
• This brings the total number of RPDDs for LP-184 to 4, including one previously granted for ATRT (Atypical Teratoid Rhabdoid Tumors).
• Efficacy of LP-184 in these three rare pediatric cancers was demonstrated through evidence of tumor regression and extended event-free survival in specialized models developed as part of the Pediatric Preclinical Testing Program (PPTP), an initiative supported by the National Cancer Institute (NCI) to identify novel therapeutic agents that may have significant activity against childhood cancers.
• Companies with RPDDs might be eligible to receive a Priority Review Voucher (PRV) upon FDA marketing approval that could be redeemed to receive a priority review for any subsequent marketing application. If received, PRVs may be used by the sponsor or sold to another sponsor and have recently sold for over $100 million(1).
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