Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease.
The FDA has signed off on Johnson & Johnson’s oncology blockbuster Darzalex Faspro for smoldering multiple myeloma, marking the first approved therapy for the indication.
The approval indicates Darzalex Faspro for high-risk adult patients, who according to J&J, are more likely to progress to active disease within two years of being diagnosed. The expansion of Darzalex Faspro enables “earlier intervention and disease interception,” the pharma said on Thursday.
The approval is backed by data from the Phase III AQUILA study, which enrolled nearly 400 patients and compared Darzalex Faspro intervention to active monitoring, also known as the watch and wait approach to surveillance. Results presented in December last year showed that the drug was able to significantly delay disease progression to active multiple myeloma, resulting in an overall 51% benefit versus active monitoring.
This effect was more pronounced in those who were classified as high-risk, with Darzalex Faspro’s benefit reaching 64%. Treatment also improved overall survival by 48%.
In May this year, the FDA’s Oncologic Drugs Advisory Committee voted 6–2 in favor of approving Darzalex Faspro for high-risk smoldering multiple myeloma.
Administered under the skin, Darzalex Faspro is a monoclonal antibody designed to bind the CD38 protein, which is found on certain subsets of cells involved in the pathology of multiple myeloma. This mechanism of action allows Darzalex Faspro to block the growth of cancer cells and trigger their death. The drug is also approved for various types of multiple myeloma and light chain amyloidosis.
Since first winning the FDA’s blessing in 2020, Darzalex Faspro has become one of J&J’s most valuable franchises. Last year, the product brought in more than $11.6 billion worldwide, accounting for more than half of the pharma’s cancer earnings. In the third quarter of this year, Darzalex Faspro emerged as J&J’s top-selling drug, hitting more than $3.6 billion in sales—nearly a 20% year-on-year growth.
Darzalex Faspro’s label expansion on Thursday is the second bit of news for the multiple myeloma space in recent weeks. Late last month, the FDA allowed the comeback of GSK’s antibody-drug conjugate Blenrep, clearing its use for third-line multiple myeloma. That approval came despite an overwhelmingly negative adcomm vote in July.
“The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, expert panelist and assistant professor at the Columbia University Medical Center, said during the committee meeting. Vasan voted against Blenrep’s approval.
