Subcutaneous Darzalex filed with FDA for multiple myeloma

Janssen Biotech has submitted a Biologics License Application (BLA) to the FDA for the subcutaneous delivery of Darzalex (daratumumab) for patients with multiple myeloma. Janssen's BLA submission follows the announcement of positive results from its Phase III COLUMBA study, which investigated subcutaneously administered Darzalex in comparison to intravenous Darzalex in patients with relapsed and refractory multiple myeloma. Subcutaneous Darzalex using ENHANZE drug delivery technology, was found to be non-inferior to intravenous Darzalex with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle.

The results showed that SC administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is non-inferior to IV administration of daratumumab with regard to the co-primary end points of overall response rate (ORR) and Maximum Trough concentration (Ctrough) of daratumumab on day 1 of the third treatment cycle. The ORR for patients treated with SC daratumumab was 41.1% (n=263) versus 37.1% in patients treated with IV daratumumab (n= 259).