Research & Development
Janssen Pharmaceutical submits sBLA with the US FDA for DARZALEX, lenalidomide and dexamethasone combination for multiple myeloma
13 March 2019 -

Pharmaceutical company Janssen Pharmaceutical Companies of Johnson & Johnson revealed on Tuesday that it has successfully filed its supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) seeking approval of DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

Based on the company's Phase 3 MAIA (MMY3008) clinical study, the sBLA is being reviewed by the US FDA under the Real-Time Oncology Review (RTOR) pilot programme, which for certain applications allows the US FDA to review data before the applicant formally submits the complete application.

The company stated the randomized, open-label, multicentre, Phase 3 study included 737 newly diagnosed patients with multiple myeloma ineligible for high-dose chemotherapy and ASCT aged 45 – 90 years old. In the DARZALEX-Rd treatment arm, patients received DARZALEX 16 milligrams per kilogram (mg/kg) IV weekly. In the DARZALEX-Rd and Rd treatment arm, the patients received 25 mg of lenalidomide on Days 1 – 21 of each 28-day Cycle and dexamethasone at 40 mg once a week.

According to the company, DARZALEX (daratumumab), the first CD38-directed antibody approved anywhere in the world, is the only CD38-directed antibody approved to treat multiple myeloma. CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. DARZALEX binds to CD38 and inhibits tumor cell growth causing myeloma cell death. DARZALEX may also have an effect on normal cells.

Multiple myeloma is reportedly an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.



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