DARZALEX is a CD38-directed cytolytic antibody 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 • as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are doublerefractory to a PI and an immunomodulatory agent.
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Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells overexpress.
In November 2015, the U.S. Food and Drug Administration (FDA) approved daratumumab for treatment of multiple myeloma in patients who had received at least three prior therapies. In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma.
In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
In May 2018, the FDA expanded the approval of daratumumab for use in combination with bortezomib, melphalan and prednisone to include the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
DARZALEX (daratumumab) injection, for intravenous use. Initial U.S. Approval – 2015
Generic Name: daratumumab
• 100 mg/5 mL solution in a single-dose vial
• 400 mg/20 mL solution in a single-dose vial
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For overseas patients, DARZALEX (daratumumab) for injection can be made available in Send your enquiry to find DARZALEX (daratumumab) for injection in China, Cambodia, Indonesia, Malaysia, the Philippines, Singapore, Thailand, Vietnam, Hong Kong. UAE Iraq, Iran, Saudi Arabia, Jordan, Mexico, Argentina, Brazil, Chile, Colombia, Peru, Venezuela. Europe – Romania, Switzerland, Georgia, Turkey, Italy, UK, Ukraine, Azerbaijan, Latvia, Poland, Slovakia. Russia CIS – Armenia, Kazakhstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan, Mongolia, Algeria, Mauritius, Uganda, Zimbabwe. Australia and New Zealand.
For DARZALEX (daratumumab) for injection Indications And Usage, Dosage And Administration, Dosage Forms And Strengths and Drug Interactions For More Details
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CHMP Issues Positive Opinion Recommending DARZALEX® (Daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma For More Details