Janssen's daratumumab accepted for accelerated CHMP assessment for treatment of European patients with heavily pre-treated multiple myeloma

Janssen-Cilag International NV announced on September 25, 2015 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). This acceptance follows the earlier regulatory submission of a MAA which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory multiple myeloma and is currently pending validation by the EMA.
Source: International Myeloma Foundation - Category: Hematology Source Type: news