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SMC backtracks on Janssen’s multiple myeloma treatment Darzalex

Will now recommend the first-in-class treatment after securing a discount

JanssenJanssen has persuaded the Scottish Medicines Consortium (SMC) to reverse its initial ruling on Darzalex (daratumumab), after the pharma group offered to cut the first-in-class drug’s price through a patient access scheme.

The SMC has now recommended the anti-CD38 antibody as a fourth line, monotherapy treatment option for adults with relapsed/refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunotherapy agent.

But patients would still have to have demonstrable disease progression following previous therapy in order to be treated with the drug.

This is a step in the right direction for Janssen, as Darzalex is the first and only approved immunotherapy that uses the patient’s own immune system with the intention to attack and kill the myeloma cells.

Jennifer Lee, director of HEMAR and advocacy at Janssen, said: “Janssen welcomes the SMC’s positive recommendation for daratumumab as a monotherapy for relapsed or refractory multiple myeloma.”

She added: “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.”

There are currently 17,500 people in the UK alone suffering with the blood cancer, with 5,500 new cases diagnosed in the UK every year.

The drug was previously rejected by the National Institute for Health and Clinical Excellence (NICE) back in March, but Janssen is hopeful it will follow in the footsteps of its Scottish counterpart and back Darzalex to be more widely used in England and Wales.

Article by
Gemma Jones

11th October 2017

From: Regulatory

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