July 21, 2023
By Matthew Shinkle
The FDA granted fast track designation to two oncology therapies.
Selinexor (Karyopharm Therapeutics) — a selective inhibitor of nuclear export — received the designation for treatment of myelofibrosis, including primary myelofibrosis, post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis.
“Selinexor’s unique mechanism of action, XPO1 inhibition, is a novel and potentially fundamental mechanism in myelofibrosis,” Reshma Rangwala, MD, PhD, chief medical officer of Karyopharm, said in a company-issued press release.
The company initiated a pivotal phase 3 trial to assess the efficacy and safety of once-weekly selinexor in combination with ruxolitinib (Jakafi, Incyte) for JAK-naive patients with myelofibrosis. Initial data are expected in 2025.
BRG01 (Biosyngen) — an adoptive immune cell therapy — received the designation for treatment of certain patients with relapsed or metastatic nasopharyngeal carcinoma. The designation applies to use of the agent by patients with Epstein-Barr virus-positive disease.
FDA granted orphan drug designation to BRG01 earlier this year.
- Karyopharm receives FDA fast track designation for selinexor for the treatment of myelofibrosis (press release). Available at: https://investors.karyopharm.com/2023-07-17-Karyopharm-Receives-FDA-Fast-Track-Designation-for-Selinexor-for-the-Treatment-of-Myelofibrosis. Published July 17, 2023. Accessed July 19, 2023.
- Biosyngen’s first-in-class cell therapy BRG01 receives FDA fast track designation (press release). Available at: https://www.biosyngen.com/index.php?m=home&c=View&a=index&aid=107. Published July 10, 2023. Accessed July 19, 2023.