FDA grants fast track designation to myelofibrosis, nasopharyngeal cancer therapies

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.