Exciting Subcutaneous Formulation Approval in MM


Ola C. Landgren, MD, PhD: Daratumumab being approved for administration as a subcutaneous [SQ] drug is a huge step forward for the myeloma field. This really gives every patient access to daratumumab. There has been some hesitation in smaller offices that don’t treat so many patients with daratumumab, given that the administration of the monoclonal antibodies as infusions took an extended window of time, at least with the first dose. There was a little bit of a barrier, but once you got up and going, it could be done in a few hours or even as rapid infusions in 90 minutes. With the subcutaneous administration, you start off really fast. It’s only an injection, so it’s a 5-minute procedure. You still will have to monitor the patient afterward, but the fact that it’s a very quick injection is of course fantastic for patients. It makes it much more feasible for doctors’ offices.

The data show, from the studies that have been presented so far, that the efficacy seems to be virtually identical compared with the IV [intravenous] drug. These are single-drug studies comparing SQ with IV. We don’t yet have a lot of data from combination strategies, but there’s no reason to believe that they wouldn’t be the same. I assume that once the drug is approved as a subcutaneous drug, it will move on in all the combinations. I think another huge benefit with the subcutaneous drug is the fact that the drug has fewer infusion-related reactions. With the intravenous drug, around 50% of the patients had an infusion reaction for the first dose and after that, it typically would never happen again.

With the subcutaneous drug, the data suggest that maybe 10% of the patients experience this. I do think there will be continued development when it comes to the premedication. It’s not fully known, but my prediction—based on my clinical experience for many years treating patients with myeloma with different types of drugs, and also treating other hematologic malignancies—is that premedication with steroids can probably be cut back. I think the antihistamine premedication can probably be cut back. The overall experience with daratumumab will be even more gentle beyond the fact that it’s now an injection. We can cut back on the premedication, I would think. We will need a little more data to fully hammer this out, but that’s my prediction.

At our program at Memorial Sloan Kettering Cancer Center, we have used daratumumab extensively with the intravenous administration. This goes back years before it was FDA approved, on clinical trials. We have used it extensively after it was FDA approved as a standard-of-care drug. We are just about to open investigator-initiated studies using the subcutaneous administration. With the FDA approval for the drug, we will obviously switch the entire program from IV to subcutaneous administration within days after the FDA signs off on all the papers.

The subcutaneous dose will definitely reduce patient time in the office, although we don’t know to what degree we need to monitor patients after the first dose with the subcutaneous drug. The data suggest that instead of 50% infusion-related reactions, which we see with IV administration, the SQ administration has about 10% infusion-related reactions. We don’t fully know what the time window should be for monitoring. I think our practice, located in the heart of New York City, will maybe let patients stroll around the city rather than sitting and waiting for many hours. But I could also see that we could potentially have patients waiting in the building instead of sitting in the chemotherapy suite and waiting for hours, as we have done when we have given the intravenous infusion. I think we will learn as we go. I do predict that we probably will loosen up on these rules and procedures going forward. To begin with, we will probably have the patient around for a few hours. After the first cycle, I could see that it will probably be a very short visit. But this is to be investigated further.

Transcript edited for clarity.

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