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Janssen scores another expansion for new Darzalex combination in the US

Myeloma med approved in combination with Amgen's Kyprolis

Johnson & Johnson’s Janssen unit has scored approval from the US Food and Drug Administration (FDA) for a new regimen of its myeloma med Darzalex in combination with Amgen’s Kyprolis.

The FDA has approved the expanded use of Darzalex (daratumumab) and dexamethasone in both once- and twice-weekly dosing regimens in combination with Kyprolis (carfilzomib), for the treatment of patients with relapsed or refractory multiple myeloma.

Importantly, this introduces a new treatment option for heavily pre-treated patients, which is crucially needed given that patient outcomes worsen with each disease relapse.

In the phase 3 CANDOR trial, researchers compared Darzalex, Kyprolis and dexamethasone to Kyprolis and dexamethasone alone in relapsed or refractory multiple myeloma patients.

The study met its primary endpoint and demonstrated a 37% reduction in the risk of disease progression or death in patients receiving Darzalex, Kyprolis and dexamethasone compared to Kyprolis and dexamethasone treatment alone.

It also demonstrated efficacy in key secondary endpoints, including overall survival rate and minimal residual disease negative-complete response at 12 months.

The overall response rate (ORR) was 84.3% for Darzalex, Kyprolis and dexamethasone compared to 74.7%, and the rate of complete response or better was 28.5% versus 10.4% in the Kyprolis and dexamethasone arm.

"With our deep disease focus and commitment to develop regimens which can help improve patient outcomes for patients with relapsed multiple myeloma, the CANDOR study further establishes another Darzalex-containing regimen which may provide benefit for this patient population,” said Craig Tendler, vice president, late development and global medical affairs, Janssen Research & Development.

Janssen has been expanding the use of Darzalex with a number of combination therapies, including its recently approved Darzalex, bortezomib, thalidomide and dexamethasone (VTd) combination.

Darzalex, which was originally developed by Danish biotech Genmab, is a monoclonal antibody (mAb) that targets the CD38 protein, which is highly expressed on multiple myeloma cells.

It also has an approval for another combination regimen made up of Darzalex, Celgene’s Revlimid (lenalidomide) and dexamethasone, for the treatment of newly diagnosed multiple myeloma patients who are ineligible for ASCT treatment.

Article by
Lucy Parsons

21st August 2020

From: Regulatory



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