Multiple myeloma is a type of blood cancer that affects plasma cells – specialized white blood cells that help the body fight infections. For years, treatment options have steadily improved, but the newest development marks one of the most meaningful steps forward yet. The U.S. Food and Drug Administration (FDA) has approved a new four‑drug (quadruplet) regimen that includes Darzalex Faspro for adults newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. This approval expands the use of a therapy that has already reshaped the treatment landscape and now strengthens its role even further.
This update matters because it gives patients access to a more powerful combination of medicines earlier in their treatment journey. Early, deeper responses to therapy are strongly linked to better long‑term outcomes, and this new regimen – known as D‑VRd – has shown impressive results in clinical trials.
What the New Approval Covers
The FDA has approved Darzalex Faspro (a subcutaneous form of daratumumab) to be used alongside three existing medications:
- Velcade (bortezomib)
- Revlimid (lenalidomide)
- Dexamethasone
Together, these four drugs form the regimen called D‑VRd. This combination is now cleared for adults who are newly diagnosed with multiple myeloma and are not eligible for an autologous stem cell transplant.
This is the first anti‑CD38 antibody‑based quadruplet regimen approved for all newly diagnosed patients, regardless of transplant eligibility. That distinction is important because it broadens access to a more effective therapy for a wider group of people.
Why This Approval Matters
A stronger start to treatment
Multiple myeloma is typically treated in phases, and the first phase – called first‑line therapy – is crucial. The goal is to reduce the amount of cancer in the body as much as possible. The new D‑VRd regimen has been shown to produce deeper responses than the previous standard three‑drug combination (VRd alone).
A more convenient formulation
Darzalex Faspro is given as an under‑the‑skin injection rather than an IV infusion. This can shorten treatment time and reduce the burden on patients who already spend many hours in medical settings.
Better long‑term potential
The earlier and more completely cancer cells are eliminated, the better the chances of delaying disease progression. The new regimen significantly improves the rate of “minimal residual disease negativity,” a measure of how thoroughly cancer cells have been cleared from the bone marrow.
What the CEPHEUS Trial Showed
The FDA approval is based on results from the large Phase 3 CEPHEUS trial, which enrolled 395 patients who were newly diagnosed and not eligible for a stem cell transplant. Participants were randomly assigned to receive either:
- D‑VRd (Darzalex Faspro + VRd)
- VRd alone
The results were striking:
Minimal Residual Disease (MRD) Negativity
MRD negativity means that extremely sensitive tests cannot detect any cancer cells in the bone marrow. Achieving MRD negativity is associated with longer survival and better long‑term outcomes.
| Outcome | D‑VRd | VRd Alone |
| MRD‑negativity rate at 22 months | 52.3% | 34.8% |
| Sustained MRD‑negativity for 12+ months | 42.6% | 25.3% |
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Progression‑Free Survival (PFS)
PFS measures how long patients live without their cancer worsening.
- The quadruplet regimen reduced the risk of disease progression or death by 40% compared to VRd alone.
Depth of Response
At nearly five years of follow‑up, 81.2% of patients receiving D‑VRd achieved a complete response or better, compared with 61.6% of those receiving VRd alone.
These results show that adding Darzalex Faspro to the standard three‑drug regimen significantly improves outcomes across multiple measures that matter to patients and families.
What This Means for Patients and Families
More effective treatment from the start
The earlier multiple myeloma is controlled, the better the long‑term outlook. This new regimen gives patients a stronger chance of achieving deep remission early in their treatment.
A therapy that works for more people
Not everyone is eligible for a stem cell transplant due to age, health conditions, or personal choice. This approval ensures that those patients still have access to a highly effective first‑line option.
A shift toward more personalized cancer care
The use of MRD negativity as a primary endpoint in the CEPHEUS trial reflects a growing trend in cancer research: measuring how thoroughly a treatment clears cancer cells, not just how long it delays progression. This helps doctors better understand which therapies offer the strongest long‑term benefits.
A more manageable treatment experience
Because Darzalex Faspro is given as an injection rather than an IV infusion, patients may spend less time in the clinic. This can make a meaningful difference in quality of life, especially for those who require frequent treatments.
Safety Considerations
Like all cancer treatments, the D‑VRd regimen comes with potential side effects. The FDA notes several important warnings and precautions, including:
- Hypersensitivity reactions
- Infections
- Neutropenia (low white blood cell count)
- Thrombocytopenia (low platelet count)
- Cardiac toxicity in patients with AL amyloidosis
These risks are not new – they are consistent with what is already known about the individual drugs in the regimen. Healthcare teams monitor patients closely and adjust treatment as needed.
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How This Approval Fits Into the Bigger Picture
Darzalex Faspro has rapidly become one of the most important therapies in multiple myeloma. It now has twelve FDA‑approved indications, including five for newly diagnosed disease. This latest approval strengthens its role as a foundational therapy across the entire treatment spectrum.
The quadruplet regimen is also the first to receive FDA approval based on a study that used MRD negativity as its primary endpoint. This milestone may influence how future multiple myeloma treatments are evaluated and approved.
Looking Ahead
The approval of D‑VRd represents a meaningful step forward for people facing multiple myeloma. It offers a more powerful first‑line option, improves the chances of deep and lasting remission, and expands access to effective therapy for those who cannot undergo a stem cell transplant.
As research continues, more advances are expected – especially in the areas of targeted therapies, immune‑based treatments, and personalized medicine. For now, this new regimen provides renewed hope and a stronger foundation for patients beginning their treatment journey.
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Sources (2)
- DARZALEX FASPRO‑based quadruplet regimen approved in the U.S. for newly diagnosed patients with multiple myeloma who are transplant ineligible
https://www.jnj.com/media-center/press-releases/darzalex-faspro-based-quadruplet-regimen-approved-in-the-u-s-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible - FDA approves daratumumab and hyaluronidase‑fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly