Kura Oncology Inc. has received the U.S. Food and Drug Administration's fast-track designation for cancer drug tipifarnib in patients with a specific mutation of head and neck squamous cell carcinoma.
The FDA grants fast-track designation for drugs that treat life-threatening diseases with an unmet medical need. The tag allows the application to progress more quickly through the regulatory process with frequent collaboration with the agency.
Tipifarnib inhibits an enzyme that is thought to lead to tumor formation and is linked to the pathway that KRAS inhibitors also block. Kura in 2018 announced that tipifarnib shrank tumors in nine out of 11 patients with head and neck squamous cell carcinoma with a mutation of the gene HRAS.
Kura expects to complete enrollment of patients in a clinical trial for tipifarnib in head and neck cancer patients in 2021 after earlier delays at certain sites.