Gilead’s idelalisib got the all-clear for breakthrough designation for chronic lymphocytic leukemia (CLL), but the FDA is treating the drug like any other therapy when it comes to refractory indolent non-Hodgkin’s lymphoma (NHL). BioCentury reports that the FDA set aside September 11 as the PDUFA date for this latter indication.
PDUFA date set for idelalisib in lymphoma
The FDA will review the drug for refractory indolent non-Hodgkin's lymphoma.