Role of Novel Subcutaneous Daratumumab in Multiple Myeloma - Episode 4

Clinical Impact of SubQ Daratumumab for Multiple Myeloma

Ola C. Landgren, MD, PhD: Access to a subcutaneous [SQ] version of daratumumab will make daratumumab even more attractive for any indication. I could see that it could be partnered even more so with drugs for up-front therapy, given that it is FDA and/or NCCN [National Comprehensive Cancer Network] Guidelines–approved. In the relapsed setting, it also gives daratumumab an upper leg compared with other drugs because it’s so easy and so well tolerated. It also is efficacious. I think that the use of daratumumab as an extended dosing regimen in the fashion of a maintenance therapy will probably become more popular. It’s not being developed as a maintenance drug, but it’s very likely that daratumumab could take the role of a continued injection over time where patients could come in and get an injection and that would be all. We will see exactly where that’s going to land. But I think the SQ route really gives daratumumab a very strong upper leg.

With daratumumab being FDA approved as a subcutaneous drug, I think that should be immediately implemented and should replace the intravenous [IV] drug. It really has a role in any setting, anything from the newly diagnosed and early disease to later stages of disease, based on the NCCN Guidelines and the FDA label. It just gives us access to a good drug for more patients because it’s easier to administer and we can pretty much use it anywhere. You don’t have the long infusion at the beginning, which we used to have with the IV formulation.

How will the subcutaneous administration route impact patients and the whole clinical procedure compared with the IV formulation? It’s quite obvious. If you have a drug that can be given as a shot, everyone likes it. The patient loves it. It’s a much shorter visit. The chemotherapy nurses like it because the patient can sit in the chair, you give an injection, and then you’re done. The overall institution likes it because you can reduce the number of chemotherapy chairs and get the work done. Of course, you still must take care of the patient. You have to monitor and make sure everything is safe, but it is a much more feasible way of using this drug.

The administration schedule for the subcutaneous version of daratumumab is the same as the IV administration. According to the FDA label, it’s once a week for 8 doses, then every other week for 8 doses, then once a month, or every 28 days to be exact. It’s the same for both of them. The subcutaneous administration has a fixed dose. The IV dose is 16 mg/kg body weight.

Transcript edited for clarity.