publication date: Nov. 29, 2016

Regulatory Actions FDA Approves New Indications for Darzalex, Keytruda, Opdivo

Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) 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.

Daratumumab was previously granted accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.

The combination approval was based on two randomized, open-label trials in which daratumumab was added to standard therapies. The POLLUX trial, also known as MMY3003, demonstrated substantial improvement in progression-free survival when daratumumab was added to lenalidomide and dexamethasone compared with lenalidomide and dexamethasone alone, the company said. The estimated median PFS had not been reached in the daratumumab arm and was 18.4 months in the control arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing a 63% reduction in the risk of disease progression or death in patients treated with daratumumab.

Similar results were observed in the CASTOR trial (also known as MMY3004), which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone. The estimated median PFS was not reached in the daratumumab arm and was 7.2 months in … Continue reading CCL Nov 2016 – FDA Approves New Indications for Darzalex, Keytruda, Opdivo

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