Johnson & Johnson (J&J) has announced that a US Food and Drug Administration (FDA) panel of experts has recommended Darzalex Faspro (daratumumab and hyaluronidase-fihj) as a treatment for smouldering multiple myeloma (SMM), an early precursor of active multiple myeloma (MM).
The regulator’s Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of the benefit-risk profile of the subcutaneous CD38-directed antibody as a monotherapy for adults for high-risk SMM.
More than 36,000 new cases of MM, a blood cancer that affects a type of white blood cell called plasma cells, are expected to be diagnosed in the US this year, according to the American Cancer Society.
SMM accounts for around 15% of all new cases of the disease and is not generally treated until active MM develops. However, recent evidence has suggested that patients at high-risk for progression to active MM could benefit from earlier therapeutic intervention.
Darzalex Faspro, which is co-formulated with Halozyme’s ENHANZE drug delivery technology, is already approved in the US for nine multiple myeloma indications, four of which are for front-line treatment in newly diagnosed patients who are transplant-eligible or ineligible.
If approved for this latest indication, the drug would be the first treatment to potentially delay or prevent progression to MM, J&J said.
The company’s application was supported by results from the phase 3 AQUILA trial comparing J&J’s drug against active monitoring in 390 SMM patients at high risk of progression.
At a median follow-up of 65.2 months, median progression-free survival (PFS) was not reached in the SC Darzalex group versus 41.5 months for active monitoring, with an estimated 60-month PFS rate of 63.1% versus 40.8%, respectively.
“Early intervention in high-risk SMM demonstrated a reduction in the risk of progression or death,” said Sen Zhuang, vice president, oncology clinical research, J&J Innovative Medicine, adding that the proactive approach in AQUILA is an example of the company’s “aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease”.
The FDA will now review the ODAC’s recommendation as it makes a final decision on Darzalex Faspro in this indication.