Why Subcutaneous Darzalex Faspro Matters for Patients With Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently approved the use of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

The effectiveness of the treatment combination was evaluated in the CEPHEUS open-label, randomized, active-controlled trial in patients with newly diagnosed multiple myeloma who were ineligible for ASCT or refused ASCT as initial therapy. In that study, more than 52% of trial participants achieved minimal residual disease negativity with D-VRd, and additionally the risk of progression or death was reduced by 40%.

CURE recently spoke with CEPHEUS study investigator Dr. Saad Z. Usmani, chief of the myeloma service at Memorial Sloan Kettering Cancer Center, to discuss the significance of the fact that Darzalex Faspro is administered subcutaneously, meaning via a simple injection, rather than by intravenously infusion.

Transcript

Can you discuss the significance of the subcutaneous administration of Darzalex Faspro?

With [Darzalex], when it first came to the market for relapsed myeloma 11 years ago, it was the IV formulation. But even at that time, around 11,10, years ago, we had started to look at the subcutaneous formulation, and eventually, that subcutaneous formulation did get regulatory approval about five and a half, six years ago for different combinations, and it's really made a difference.

The IV formulation used to be long days for patients early on, and then even when, if we were able to deliver it faster, it would still need three- or four-hour days or visits to the infusion center, whereas the subcutaneous formulation patients get in under five minutes.

From a historic standpoint, the subcutaneous formulation was actually approved right as we were hitting the pandemic. It was the first or the second quarter of 2020, so it came at essentially the right time, because at that time, we were trying to really limit the exposure of our patients to the healthcare setting and avoid the COVID exposure in the pandemic.

References

1. “FDA Approves Darzalex Faspro-VRd For Newly Diagnosed, Transplant Ineligible Multiple Myeloma,” CURE; https://www.curetoday.com/view/fda-approves-darzalex-faspro-vrd-for-newly-diagnosed-transplant-ineligible-multiple-myeloma

Transcript has been edited for clarity and conciseness.

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