- Johnson & Johnson and Genmab are seeking priority review status for daratumumab, an IgG1k antibody that binds to CD38 on the surface of multiple myeloma cells.
- In a study of 42 patients with advanced multiple myelmona published in the New England Journal of Medicine (NEJM), 36% of daratumumab-treated patients responded to treatment.
- Among the responders, two-thirds had experienced progression-free survival (PFS) at the 12-month mark.
J&J and Genmab have partnered on the development and commercialization of daratumumab, and are going after a priority review designation from the FDA based on the strength of their first bit of human clinical trial data. Refractory multiple myeloma is difficult to treat and considered an area where more treament options are needed.
There are several key players in this space in addition to J&J/Genmab, including Bristol-Myers Squibb and AbbVie with elotuzumab, currently in phase III; Amgen, which acquired Krypolis from Onyx; and Celgene with Pomalyst. Each of these drugs have novel mechanisms of action and bring something unique to the treatment of multiple myeloma. And the intention is to use these drugs as part of combination therapy regimens.
It would seem that J&J's effort to get a priority review designation for daratumumab has a good chance of succeeding, given the fact taht Krypolis was approved for multiple myeloma based on an overall repsonse rate (ORR) of 23%—considerably lower than the ORR for daratumumab. More clinical data is needed before J&J/Genmab can file, but they are moving in the right direction.