FDA’s green light for biopharmaceutical company’s drug candidate builds upon previous approval to treat pancreatic cancer.
Lantern Pharma said that the FDA has granted LP-184 Orphan Drug Designation as a new treatment of glioblastoma multiforme (GBM) and other malignant gliomas, which follows the recent announcement of the approval of the drug to be used for pancreatic cancer treatment.
“GBM represents an important, underserved clinical opportunity, with a significant unmet medical need," Panna Sharma, Lantern Pharma’s president and CEO said in a statement. "This second Orphan Drug Designation from the FDA for the LP-184 program marks another major milestone and is further validation of the power of our data-driven approach to oncology drug development, aimed at more targeted and effective oncology therapies."
LP-184 is a small-molecule drug candidate that damages DNA in cancer cells that over-express biomarkers or harbor mutations in DNA repair pathways, according to the statement.
The drug targets cancers, including GBM, which is a rare disease with an overall 5-year survival rate of 5%, as well as pancreatic cancer.
Lantern Pharma is a biopharmaceutical company that uses artificial intelligence called RADR that helps discover biomarker signatures identifying patients most likely to respond to its genome-targeted therapeutics.
The FDA’s Office of Orphan Products Developments grants approval and orphan status to drugs that are effective and safe for conditions or diseases that affect fewer than 200,000 individuals in the United States.
FDA grants Lantern Pharma additional Orphan Drug Designation for drug candidate LP-184 in glioblastoma multiforme & malignant gliomas. Lantern Pharma. August 30, 2021. Accessed August 31, 2021. https://www.prnewswire.com/news-releases/fda-grants-lantern-pharma-additional-orphan-drug-designation-for-drug-candidate-lp-184-in-glioblastoma-multiforme--malignant-gliomas-301365111.html