New Quadruplet Therapy Approved By the FDA for Newly Diagnosed Transplant-Eligible Patients

There's exciting news for patients recently diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The U.S. Food and Drug Administration (FDA) recently approved a new treatment regimen that shows promise in improving outcomes for this specific group.

New Daratumumab-based Combination for Newly Diagnosed Myeloma

This newly FDA-approved regimen combines daratumumab administered subcutaneously (Darzalex Faspro, Johnson & Johnson) with three established multiple myeloma drugs: bortezomib, lenalidomide, and dexamethasone (known as VRd). This four-drug combination, often referred to as a "quadruplet therapy, " is designed to deliver a more powerful attack against multiple myeloma cells, potentially leading to deeper remissions and improved survival rates.

The FDA's decision was based on positive results from the PERSEUS clinical trial (NCT03710603), which studied the efficacy and safety of this daratumumab-based quadruplet therapy in newly diagnosed transplant-eligible multiple myeloma patients. You can find a more detailed explanation of the PERSEUS trial and its potential impact in our previous article from ASCO 2024: "More is Better for Newly Diagnosed Myeloma".

The Importance of Discussing Transplant Eligibility with Your Medical Team

This new quadruplet regimen has been approved only for those patients with myeloma who are considered eligible for a stem cell transplant. Determining whether you are a candidate for a stem cell transplant is a critical decision that should be made in close consultation with your medical team. They will assess your overall health, the stage of your multiple myeloma, and other factors to determine if this treatment option is right for you.

If you are found to be transplant-eligible, your doctor will discuss the potential benefits and risks of the procedure, as well as the available treatment options, including quadruplet therapies.

What this means for you:

If you've been diagnosed with multiple myeloma and are considering a stem cell transplant, this FDA approval is a significant development. Discuss with your medical team if a quadruplet therapy might be right for you. It's important to weigh the potential benefits against any possible side effects associated with the combination therapy.

Even though daratumumab was first approved back in November 2015, researchers are still gathering information about the best way to combine it and identifying which patients will benefit the most from it. This FDA approval offers a promising new option for newly diagnosed transplant-eligible multiple myeloma patients.

Continue learning about treatment options for newly diagnosed patients with HealthTree University:

explore healthtree university for multiple myeloma.

Sources:

• FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma
• DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
• Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma (Perseus)