FDA Approves New Immunotherapy for Multiple Myeloma Patients
The US Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX (daratumumab) in combination with pomalidomide and dexamethasone to treat patients with multiple myeloma.
DARZALEX is the first-ever approved CD38-directed antibody.
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To be eligible to receive DARZALEX, patients with multiple myeloma must have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI).
DARZALEX was first approved in November 2015 by the FDA as a monotherapy treatment for multiple myeloma patients who have received at least 3 prior lines of therapy, including a PI and an immunomodulatory agent, or who are refractory to both a PI and an immunomodulatory agent.
DARZALEX was approved again by the FDA in 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat patients with multiple myeloma who have received at least 1 prior therapy.
The FDA recommends a dose of 16 mg/kg body weight via intravenous infusion. For the first 8 weeks of treatment, DARZALEX is administered weekly in combination with pomalidomide and dexamethasone. The dose is reduced to every 2 weeks from weeks 9 to 24, and eventually every 4 weeks after week 25.
Janssen Biotech (JNJ) granted FDA approval for DARZALEX (daratumumab) in combination with pomalidomide & dexamethasone [press release]. Horsham, PA. StreetInsider. https://www.streetinsider.com/Corporate+News/Janssen+Biotech+%28JNJ%29+Granted+FDA+Approval+for+DARZALEX+%28daratumumab%29+in+Combination+with+Pomalidomide+%26+Dexamethasone/13019793.html. Accessed June 19, 2017.