New approval for newly diagnosed, transplant-ineligible multiple myeloma
Now Approved
New Regimen for Adult Patients With Newly Diagnosed, Transplant- Ineligible Multiple Myeloma
Janssen Biotech, Inc., is pleased to announce the approval of DARZALEX® in combination with Revlimid® (lenalidomide) and dexamethasone (DRd) to treat adult patients with newly diagnosed, transplant-ineligible multiple myeloma (MM).
DARZALEX® + Rd demonstrated longer PFS and deep responses with newly diagnosed, transplant-ineligible MM in the MAIA study.1
Median PFS still not reached with DARZALEX® + Rd after 28 months of follow-up* vs 31.9 months for Rd alone1,2
44% reduction in the risk of disease progression or death with DARZALEX(R) + Rd vs Rd alone
DRd=DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); HR=hazard ratio; PFS=progression-free survival; Rd=lenalidomide (R) + dexamethasone (d).
 * Range: 0.0–41.4.
  Kaplan-Meier estimate.
44% reduction in the risk of disease progression or death with DARZALEX® + Rd vs Rd alone1
At 30 months: 70.6% of patients had not progressed with DRd vs 55.6% of patients in the Rd group (DRd: 95% CI, 65.0–75.4; Rd: 95% CI, 49.5–61.3).2
Please see Important Safety Information below.
ORR was achieved with DARZALEX® + Rd1‡
93% overall response rate achieved with DARZALEX(R) + Rd vs 81% with Rd alone
CR=complete response; ORR=overall response rate; PR=partial response; sCR=stringent complete response; VGPR=very good partial response.
 § sCR is CR plus the attainment of normal free light chain ratio and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.2
DRd nearly doubled the number of patients who achieved a CR or better vs Rd alone1
Study Design: MAIA, an open-label, randomized, phase 3 study, compared treatment with DARZALEX® + lenalidomide + dexamethasone (DRd) (n=368) to Rd (n=369) in adult patients with newly diagnosed, transplant-ineligible MM. Treatment was continued until disease progression or unacceptable toxicity. The primary efficacy endpoint was PFS. See Study Design details in the Clinical Studies section (14.1) of the full Prescribing Information.
Learn about DARZALEX® + Rd, click here.
To learn more about the recent approval for this new indication, read the press release.
DARZALEX® is indicated for the treatment of adult patients with multiple myeloma:
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
DARZALEX® (daratumumab) is contraindicated in patients with a history of severe hypersensitivity (eg, anaphylactic reactions) to daratumumab or any of the components of the formulation.
Infusion Reactions — DARZALEX® can cause severe and/or serious infusion reactions, including anaphylactic reactions. In clinical trials, approximately half of all patients experienced an infusion reaction. Most infusion reactions occurred during the first infusion and were Grade 1-2. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing DARZALEX® . 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 if an anaphylactic reaction or life-threatening (Grade 4) reaction occurs and institute appropriate emergency care. 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 corticosteroids for patients with chronic obstructive pulmonary disease.
Interference With Serological Testing — Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient's serum. The determination of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX® . Type and screen patients prior to starting DARZALEX®.
Neutropenia and Thrombocytopenia — DARZALEX® may increase neutropenia and/or thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to the manufacturer's prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. DARZALEX® dose delay may be required to allow recovery of neutrophils and/or platelets. No dose reduction of DARZALEX ® is recommended. Consider supportive care with growth factors for neutropenia or transfusions for thrombocytopenia.
Interference With Determination of Complete Response — Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Adverse Reactions — The most frequently reported adverse reactions (incidence ≥20%) were: infusion reactions, neutropenia, thrombocytopenia, fatigue, asthenia, nausea, diarrhea, constipation, decreased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, bronchitis, pneumonia and upper respiratory tract infection.
DARZALEX® in combination with lenalidomide and dexamethasone (DRd): The most frequent (≥20%) adverse reactions for newly diagnosed or relapsed refractory patients were, respectively, infusion reactions (41%, 48%), diarrhea (57%, 43%), nausea (32%, 24%), fatigue (40%, 35%), pyrexia (23%, 20%), upper respiratory tract infection (52%, 65%), muscle spasms (29%, 26%), dyspnea (32%, 21%), and cough (30%, 30%). In newly diagnosed patients, constipation (41%), peripheral edema (41%), back pain (34%), asthenia (32%), bronchitis (29%), pneumonia (26%), decreased appetite (22%), and peripheral sensory neuropathy (24%) were also reported. In newly diagnosed patients, serious adverse reactions (≥2% compared to Rd) were dehydration (2%), bronchitis (4%), and pneumonia (15%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (≥20%) were leukopenia (35%), neutropenia (56%), and lymphopenia (52%). In relapsed/refractory patients, serious adverse reactions (≥2% compared to Rd) were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%), and pyrexia (3%), and treatment-emergent Grade 3-4 hematology laboratory abnormalities (≥20%) were neutropenia (53%) and lymphopenia (52%).
Please click here to see the full Prescribing Information.
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09/19  cp-109602v1

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