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Scottish Medicines Consortium approve multiple myeloma treatment daratumumab (Darzalex▼) for use by NHS Scotland

Darzalex▼, for Multiple myeloma from Janssen-Cilag

The Scottish Medicines Consortium have approved Janssen-Cilag's multiple myeloma treatment daratumumab, brand name Darzalex▼ for use by NHS Scotland in adult patients.

This means that Darzalex will be funded by NHS Scotland and made available to patients who qualify.

Darzalex is approved as an option, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Darzalex should only be used in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received one prior therapy only.

Progression-free survival was significantly longer in patients who received daratumumab in combination with bortezomib and dexamethasone compared with those who received bortezomib and dexamethasone in a phase III study in patients with multiple myeloma who had received at least one prior therapy.

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About Darzalex (source EMA)
Darzalex is a cancer medicine used to treat adults with multiple myeloma (a cancer of the bone marrow). It is used:
  • in combination with the medicines bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (a transplant of the patient's own blood-producing cells). Bortezomib and melphalan are used for treating multiple myeloma and prednisone suppresses the immune system;
  • on its own when the disease has come back after treatment with cancer medicines (including medicines known as proteasome inhibitors) and immunomodulatory medicines (that act on the immune system), or when the disease has not improved with these medicines;
  • in combination with dexamethasone (a medicine that suppresses the immune system) plus either lenalidomide or bortezomib in patients who have previously received other treatment for the disease. Lenalidomide and bortezomib are medicines used for treating multiple myeloma.
Multiple myeloma is rare and Darzalex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 July 2013.

The active substance in Darzalex, daratumumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD38, which is found in high amounts on multiple myeloma cells. By attaching to CD38 on the multiple myeloma cells, daratumumab activates the immune system to kill the cancer cells.

Darzalex was first made available in the EU in 2017. It is manufactured by Janssen-Cilag.

Sources
European Medicines Agency website page for Darzalex
Accessed 11/07/19
Links available in full article

SMC information on Darzalex

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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