Biologics

Darxalex Faspro sBLA for Smoldering Multiple Myeloma

Johnson & Johnson has submitted a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use as monotherapy for treating adult patients with high-risk smoldering multiple myeloma. The filing is based on data from the ongoing Phase 3 AQUILA study (NCT03301220).

Smoldering multiple myeloma is described as an early precursor of active multiple myeloma, where abnormal cells can be detected in the bone marrow, but patients are typically asymptomatic. “Fifteen percent of all cases of newly diagnosed multiple myeloma are classified as smoldering multiple myeloma, and half of those diagnosed with high-risk disease will progress to active multiple myeloma within two years,” the company says.

Typically, J&J says smoldering multiple myeloma is not treated until active multiple myeloma develops. The standard approach is to observe and track the disease for signs of biochemical progression or organ damage before starting therapy. “Recent evidence suggests that those at high-risk for progression to active multiple myeloma could benefit from earlier therapeutic intervention,” it says.

Data from the AQUILA study will be presented at the 2024 American Society of Hematology annual meeting in San Diego 12/7-10. The study’s primary endpoint is progression-free survival, and secondary endpoints include time to progression, overall response rate and overall survival. “Patients in the study were diagnosed with smoldering multiple myeloma in the last five years and were excluded if they had prior exposure to approved or investigational treatments for smoldering multiple myeloma or multiple myeloma,” the company says.

Darzalex Faspro received initial approval 5/2020, and is currently approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or) ineligible.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome