Janssen’s Much Awaited FDA Approval

Janssen’s Pharmaceutical, is the Belgium based pharmaceutical division owned by Johnson & Johnson focused on solving the unmet medical needs announced on Monday, July 12, that the company has received its much-awaited United States Food and Drug Administration Approval for DARZALEX FASPRO® scientifically referred to as daratumumab and hyaluronidase-fihj along with the Approval of pomalidomide, and dexamethasone allowing their use in treating adult patients with multiple myeloma condition who have a previous medical history with experiencing at least one line of therapy involving lenalidomide, and a proteasome inhibitor.

The Approval was granted after the regulatory submission to the U.S. FDA in November 2020. The results derived from the Phase 3 Apollo study were displayed at the 202 American Society of Hematology (ASH) during the annual meeting, and the study was recently released in The Lancet Oncology.

Clinical research such as the Apollo study have exposed the ability of daratumumab-based combination treatment routines to impose a significant impact in reducing the progression risk in patients suffering from multiple myeloma, shared Meletios A. Dimopoulos, M.D., Professor, and Chairman managing the department of Clinical Therapeutics housed at the National as well as Kapodistrian University of Athens School of Medicine, Greece.

Apollo is recognized as an effort reflecting multicenter, Phase 3, non-specific or randomized open-label study comparing the effects of DARZALEX FASPRO® in patients with relapsed or refractory multiple myeloma. The study gathered 304 participants. The primary endpoint is progression-free survival (PFS), whereas the secondary endpoints consist of overall response rate (ORR).