SMC rejects Janssen’s multiple myeloma treatment Darzalex

pharmafile | January 17, 2017 | News story | Manufacturing and Production, Sales and Marketing Janssen, SMC, darzalex 

The Scottish Medicines Consortium (SMC) has decided not to recommend Janssen’s Darzalex (daratumumab) for routine use by NHS Scotland as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma who have previously a proteasome inhibitor and an immunomodulatory agent and whose disease has shown progression since their last treatment.

Janssen voiced its disappointment at the decision, claiming the SMC rejected the drug despite meeting the organisation’s end-of-life criteria and holding orphan drug status, and despite the offer of a patient access scheme which was rejected by the Patient Access Scheme Assessment Group (PASAG). Jennifer Lee, Janssen’s director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy, commented:

“At Janssen, our priority is to ensure that patients have access to a range of innovative treatments that they and their doctors feel are appropriate for them. The rare and aggressive nature of multiple myeloma and the lack of effective and well-tolerated treatment options for patients who have been previously treated and become resistant to other therapies means that there is a real and urgent need for new options like daratumumab. We will continue to work collaboratively with the SMC and remain committed to finding a solution so that patients and doctors in Scotland can access the medicines they need.”

Combined efficacy analysis Phase 2 and 1/2 trials showed that median overall survival (OS) for single-agent daratumumab was 20.1 months after an average follow-up of 20.7 months, with 69% surviving up to 12 months compared to an average survival of 5-9 months for current treatments. In addition, overall response rate (ORR) was 31% with 83% achieving stable disease or better.

Matt Fellows

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