FDA grants fast track designation to TK216 in Ewing sarcoma

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA granted Fast Track Designation to ets-family inhibitor TK216 in Ewing sarcoma patients that have relapsed or are refractory to standard of care therapy.

Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma.

TK216 is a first-in-class small molecule that inhibits the biological activity of ets-family transcription factor oncoproteins in a variety of tumor types, stopping cancer cell growth and tumor formation, according to the company. In Ewing sarcoma, it is designed to target a single and well-characterized genetic mutation that causes the disease.

YOU MAY BE INTERESTED IN

Despite steady progress in reducing overall cancer mortality rates, cancer incidence in women is rising, according to the American Cancer Society’s “Cancer Statistics, 2025” report. Incidence rates in women 50-64 years of age have surpassed those in men, and rates in women under 50 are now 82% higher than their male counterparts, up from 51% higher in 2002. In 2021, for the first time, lung cancer incidence was higher in women under 65 than in men. 
Over the past five years, Cedars-Sinai Cancer has built an integrated, regional system designed to provide cancer care close to where patients live and work. This model of care, directed by an academic medical center to patients at the community level, proved to be the best possible approach to supporting patients in our 11-million-person catchment area during the worst fire disaster in California history. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login