Superior ef cacy in combination
DARZALEX ® (daratumumab) + Rd signi cantly improved PFS vs Rd alone 1
100
63
80
reduction in the risk of
disease progression or
death with DARZALEX ® + Rd
60
40
DARZALEX ® + Rd
Rd
20
P<0.0001
HR=0.37 (95% CI: 0.27, 0.52)
0
0
91.3
%
%
3
6
9
12
Months
15
18
21
POLLUX was an open-label, randomized,
active-controlled phase 3 trial comparing
treatment with DARZALEX ® 16 mg/kg + Rd
(n=286) to Rd alone (n=283) in multiple
myeloma patients who received a minimum of
1 prior therapy. Patients receiving DARZALEX ®
were treated with pre- and post-infusion
medications. Patients were treated until
unacceptable toxicity or disease progression.
Ef cacy was evaluated by PFS based on
International Myeloma Working Group
(IMWG) criteria. 1
ORR with DARZALEX ® + Rd vs 74.6% with Rd alone (P<0.0001). CR or better was 42.3% with DARZALEX ® + Rd vs 18.8%
with Rd alone. VGPR was 32.2% vs 24.4%, and PR was 16.8% vs 31.4% with DARZALEX ® + Rd vs Rd alone, respectively. 1
Rd=lenalidomide and dexamethasone; PFS=progression-free survival; HR=hazard ratio; ORR=overall response rate; CR=complete response; VGPR=very good partial
response; PR=partial response.
Indication
DARZALEX ® (daratumumab) is indicated in combination
with lenalidomide and dexamethasone, or bortezomib and
dexamethasone, for the treatment of patients with multiple
myeloma who have received at least one prior therapy.
Important Safety Information
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS
Infusion Reactions
DARZALEX ® can cause severe infusion reactions. Approximately
half of all patients experienced a reaction, most during the
rst infusion. Infusion reactions can also occur with subsequent
infusions. Nearly all reactions occurred during infusion or within
4 hours of completing an infusion. Prior to the introduction of
post-infusion medication in clinical trials, infusion reactions
occurred up to 48 hours after infusion. Severe reactions
have occurred, including bronchospasm, hypoxia, dyspnea,
hypertension, laryngeal edema and pulmonary edema. Signs
and symptoms may include respiratory symptoms, such as nasal
congestion, cough, throat irritation, as well as chills, vomiting
and nausea. Less common symptoms were wheezing, allergic
rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.
Pre-medicate patients with antihistamines, antipyretics, and
corticosteroids. Frequently monitor patients during the entire
infusion. Interrupt infusion for reactions of any severity and
institute medical management as needed. Permanently
discontinue therapy for life-threatening (Grade 4) reactions.
For patients with Grade 1, 2, or 3 reactions, reduce the infusion
rate when re-starting the infusion.
To reduce the risk of delayed infusion reactions, administer oral
corticosteroids to all patients following DARZALEX ® infusions.
Patients with a history of chronic obstructive pulmonary disease
may require additional post-infusion medications to manage
respiratory complications. Consider prescribing short- and long-
acting bronchodilators and inhaled co