Fennec Pharmaceuticals Inc. secured the U.S. Food and Drug Administration's breakthrough therapy status for its drug Pedmark.
Pedmark prevents ototoxicity, or ear damage, as a side-effect of cisplatin chemotherapy in children with standard-risk hepatoblastoma. Hepatoblastoma is a very rare cancerous tumor that starts in the liver and primarily affects children.
The therapy previously received the FDA's fast track designation. The designation allows the regulator to accelerate the review process for drugs indicated to treat serious and life-threatening conditions.
The breakthrough therapy designation will include all features of the fast track, as well as more intensive FDA guidance on an efficient drug development program.
Research Triangle Park, N.C.-based Fennec is a biopharmaceutical company that develops product candidates for use in the treatment of cancer in the U.S.