FDA Approval of Darzalex in Early Relapse Setting a Game Changer

On November 21^st, Darzalex® (daratumumab) was approved by the US Food and Drug Administration in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone for the treatment of myeloma patients who have received at least one prior therapy. This represents a remarkably rapid extension of the initial label for use as monotherapy in the relapse/refractory setting granted in November 2015. Based upon the POLLUX (Rd) and CASTOR (Vd) datasets, there is now a new standard of care for patients at first relapse or even with inadequate initial response.

This is great news for patients and will set a new standard of care. There are now multiple options for myeloma patients at first relapse, including combinations with carfilzomib (Kyprolis®), ixazomib (Ninlaro®), and elotuzumab (Empliciti®)—all recently approved, but without direct comparative results. This will force both doctors and patients to look closely at the data and try to decide what is best in each case. But what is a game changer, is that the Darzalex data are so strong that it may well emerge as the preferred choice by many. The high response rates and prolonged remissions, which I have discussed before in blog posts here and here, are truly impressive.

Of note, the FDA has also set a PDUFA date of June 17, 2017 for the Darzalex, Pomalyst®/dex combination, meaning that the Darzalex combinations will most likely be available across the disease spectrum.

A new “backbone” agent is a real breakthrough and will transform the treatment landscape for the better.