Express reduces the risk of disease progression by 37%, Janssen’s CD38 antibody combination is approved for second-line treatment of multiple myeloma

▎Janssen, the editor of WuXi AppTec's content team, announced today that the U.
S.
FDA has approved Darzalex Faspro in combination with pomalidomide and dexamethasone (Pd) for the treatment of at least one previous pre-treatment Treatment of adult patients with multiple myeloma (MM)
.

This approval marks the sixth indication for Darzalex Faspro for the treatment of multiple myeloma
.

This approval is based on the results of a phase 3 clinical trial called APOLLO
.

This result was recently published in The Lancet Oncology
.

The APOLLO study reached the primary endpoint of improving progression-free survival (PFS).
Compared with Pd therapy, the combination of Darzalex Faspro and Pd can significantly reduce the risk of disease progression or death by 37% (HR, 0.
63; 95% CI, 0.
47- 0.
85; P=0.
0018)
.

The median PFS of Darzalex Faspro+Pd group and Pd group were 12.
4 months and 6.
9 months, respectively
.

In addition, the results of the study showed that Darzalex Faspro+Pd had a higher overall response rate (69% vs.
46%) compared with Pd alone
.

In addition, compared with patients who received only Pd treatment, more patients who received Darzalex Faspro+Pd treatment showed negative status of minimal residual disease (9% vs.
2%)
.

Darzalex Faspro, jointly developed by Janssen and Genmab, is the first anti-CD38 antibody that can be administered by subcutaneous injection, reducing the time for patients to receive treatment from a few hours to a few minutes
.

In addition to receiving FDA approval for the treatment of multiple myeloma, it has also been approved for the treatment of immunoglobulin light chain amyloidosis
.

"We are focusing on the continuous development of Darzalex Faspro and advancing this innovative therapy for patients who need additional treatment options
.

" said Dr.
Craig Tendler, vice president of post-development and global medical affairs at Janssen Research & Development.
"Today's Approval makes Darzalex Faspro the first subcutaneously administered anti-CD38 monoclonal antibody in combination with the widely used pomalidomide and dexamethasone regimens
.

"Reference: [1] Janssen Announces US FDA Approval of DARZALEX FASPRO® (daratumumab) and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse.
Retrieved July 12, 2021, from https:// -faspror-daratumumab-and-hyaluronidase-fihj-combination Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
.

If you need guidance on treatment plans, please go to a regular hospital for treatment
.