FDA has granted Lantern Pharma, an AI-driven oncology company, Rare Pediatric Disease Designation (RPDD) for investigational drug candidate LP-184, in three pediatric cancers: malignant rhabdoid tumors (MRT), rhabdomyosarcoma (RMS), and hepatoblastoma.
Panna Sharma, CEO and President of Lantern Pharma, acknowledged harnessing AI and data-driven approaches to revolutionize cancer drug development, aiming to dramatically reduce costs, accelerate timelines, and enhance precision in bringing new therapies to patients.
He further acknowledged a significant breakthrough in identifying three additional high-potential indications for LP-184 in pediatric cancers, exemplifying this progress.
The FDA’s RPDD for the three potential programs was acknowledged as a testament to this commitment and marked a key step in advancing a growing pediatric cancer portfolio.
Lantern Pharma is currently conducting a multi-center phase 1A clinical trial to evaluate the safety and efficacy of LP-184 in patients with various solid tumors.
The company planned to use data from the trial to guide future clinical development, including potential studies for pediatric patients with MRT, RMS, and hepatoblastoma.
The RPDD designation may also qualify Lantern Pharma for a Priority Review Voucher (PRV) upon FDA approval of LP-184.
Source: Lantern Pharma Announces Three U.S. FDA Rare Pediatric Disease Designations Granted to LP-184 in Multiple Ultra Rare Children’s Cancers
https://www.businesswire.com/news/home/20240923042569/en/Lantern-Pharma-Announces-Three-U.S.-FDA-Rare-Pediatric-Disease-Designations-Granted-to-LP-184-in-Multiple-Ultra-Rare-Children%E2%80%99s-Cancers
