publication date: Jun. 28, 2019
Drugs & Targets
FDA approves Darzalex + lenalidomide and dexamethasone in multiple myeloma patients ineligible for transplant
FDA has approved the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The agent is sponsored by Genmab A/S.
The supplemental Biologics License Application for this indication was submitted by Genmab’s licensing partner, Janssen Biotech Inc., under the Real-Time Oncology Review pilot program. In Aug. 2012, Genmab granted Janssen Biotech Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
The approval was based on data from the phase III MAIA (MMY3008) study of daratumumab in combination with lenalidomide and dexamethasone as treatment for patients with newly diagnosed multiple myeloma, who are not candidates for high dose chemotherapy and ASCT. Data from this study was presented as a Late-Breaking Abstract at the 2018 American Society of Hematology Annual Meeting in December 2018.
The phase III study (NCT02252172) is a randomized, open-label, multicenter study that includes 737 newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT.
Patients were randomized to receive either daratumumab in combination with lenalidomide (an immunomodulatory drug) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone.
In the daratumumab treatment arm, patients received 16 mg/kg weekly for first 8 weeks (Cycles 1 and 2), every other week for 16 weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond) until progression of disease or unacceptable toxicity. Lenalidomide was administered at 25 mg orally on days 1 through 21 of each 28-day cycle, … Continue reading FDA approves Darzalex + lenalidomide and dexamethasone in multiple myeloma patients ineligible for transplant
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