ODAC backs delay for Karyopharm’s selinexor

With uncertainty regarding the benefits and toxicity concerns with multiple myeloma candidate selinexor from Karyopharm Therapeutics Inc. (NASDAQ:KPTI), FDA's Oncologic Drugs Advisory Committee voted 8-5 that FDA should delay a decision on the product's approval until data from the Phase III BOSTON trial are available.

BOSTON is evaluating selinexor in MM patients who have received one to three prior lines of therapy. Karyopharm said it expects top-line data from BOSTON by the end of 2019 or into 2020...