Karyopharm Therapeutics Inc. has submitted a New Drug Application to FDA, seeking accelerated approval for Xpovio (selinexor), the company’s first-in-class, oral selective inhibitor of nuclear export (SINE) compound, as a new treatment for patients with relapsed or refractory diffuse large B-Cell lymphoma after at least two prior multi-agent therapies and who are ineligible for stem cell transplantation, including CAR-T cell therapy.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
