The U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) voted

The U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in support of DARZALEX FASPRO® for high-risk smoldering multiple myeloma (HR-SMM). This vote suggests that the committee thinks the drug's benefits are greater than the risks for these patients. 

The U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in support of DARZALEX FASPRO® for high-risk smoldering multiple myeloma (HR-SMM). This vote suggests that the committee thinks the drug's benefits are greater than the risks for these patients.

DARZALEX FASPRO® is made up of daratumumab and hyaluronidase-fihj. If the FDA approves it, this drug could become the first option to help delay or prevent the progression to more severe multiple myeloma.

The recommendation is based on the positive results from the Phase 3 AQUILA study, which showed that DARZALEX FASPRO® improved progression-free survival. Currently, there are no approved treatments specifically for HR-SMM. Most doctors use a strategy of close monitoring and wait to treat until the disease progresses. Although HR-SMM doesn't show symptoms, around half of these patients may develop active multiple myeloma in two to three years.

The ODAC reviewed data from the AQUILA study, which compared patients using DARZALEX FASPRO® to those under standard monitoring. Approved by the FDA since May 2020 for multiple uses in multiple myeloma, DARZALEX FASPRO® could offer a way to help patients earlier if approved for HR-SMM.

While ODAC has given a positive recommendation, the FDA will make the final decision regarding approval.