Darzalex FasPro Receives FDA Approval for Use with Pomalidomide and Dex in Multiple Myeloma
Darzalex Faspro, the subcutaneous 5 minute shot version of daratumumab, has been FDA approved for use with pomalidomide and dexamethasone for multiple myeloma patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval is the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma.
The approval was based on the APOLLO study data published in The Lancet Oncology.
"Clinical studies including APOLLO have continued to show the ability of daratumumab-based combination treatment regimens to significantly reduce the risk of progression in patients with multiple myeloma," said Meletios A. Dimopoulos, M.D.*, Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator. "With this approval, we are now able to combine pomalidomide and dexamethasone with a daratumumab subcutaneous option that can be administered in minutes rather than the hours needed for intravenous administration."
The APOLLO study targeted progression free survival as its end point. In the study, Darzalex Faspro with pomalidomide and dex reduced the risk of progression or death by 37 percent compared to pomalidomide and dex alone.
|Progression Free Survival||12.4 months||6.9 months|
|Very Good Partial Response||51%||20%|
Only 2% of patients stopped the Darzalex Faspro/Pom/Dex due to serious side effects (1 patient). The most common side effects were fatigue, pneumonia, upper respiratory tract infection, and diarrhea. The most frequent serious adverse reactions in >5 percent of patients who received Darzalex Faspro/Pom/Dex were pneumonia (15 percent) and lower respiratory tract infection (12 percent). Fatal adverse reactions occurred in 7 percent of patients who received Darzalex Faspro/Pom/Dex.
To prevent infusion related reactions, patients are pre-treated with steroids, benadryl or other histamine blocker and acetaminophen before Darzalex Faspro administration for the first and second injections.
Darzalex Faspro is currently approved for the treatment of adult patients with multiple myeloma:
- in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
- in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
- in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
- in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
- in combination with pomalidomide and dexamethasone in patients who have received at least one prior line of therapy including lenalidomide and a proteosome inhibitor
- as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent
The additional approval and easier administration is welcome by myeloma patients as yet another treatment combination option for the treatment of multiple myeloma.