Erasca's ERAS-801 Gets FDA's Orphan Drug Status

(RTTNews) - Erasca, Inc. (ERAS) Thursday announced that the FDA has granted orphan drug status to to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma.

ERAS-801 is an orally bioavailable, small molecule EGFR inhibitor that exhibited substantial central nervous system penetration in preclinical animal studies.

FDA grants orphan drug status to treatments that address rare medical diseases or conditions affecting less than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.

"GBM is an aggressive malignancy afflicting approximately 37,000 patients annually in the United States and Europe. Currently approved EGFR inhibitors are limited by insufficient CNS penetration to treat GBM and minimal activity against GBM-specific EGFR amplifications, mutations, and other molecular alterations, which contribute to high rates of relapse and a five-year survival rate below 10%," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder.