Scottish Medicines Consortium Positive Recommendation for Darzalex Offers Alternative Second-line Treatment Option for Incurable Blood Cancer, Multiple Myeloma

High Wycombe, 8 July 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Scottish Medicines Consortium (SMC) has recommended daratumumab plus bortezomib and dexamethasone, as an option for treating relapsed multiple myeloma in people who have had only one previous treatment.1 This follows the National Institute for Health and Care Excellence (NICE) recommendation in March 2019 for the same indication, for use within the Cancer Drugs Fund (CDF).[6]

Myeloma, also known as multiple myeloma, is a blood cancer arising from plasma cells.[7] Latest mortality data from Cancer Research UK show that there were 266 deaths from myeloma in Scotland in 2017.[8] Multiple myeloma is incurable but treatment can often help to control symptoms and improve quality of life.[9] Patients who relapse after treatment with standard therapies, have poor prognoses and few treatment options available.[10]

In making its recommendations, the SMC considered evidence from the phase III CASTOR study which showed that the combination extended the 12-month length of time people live before their disease progresses by 60.7% versus 26.9% in the control group.2 Clinical experts consulted by the SMC also noted that daratumumab filled an unmet need for patients with relapsed multiple myeloma ‘as this is an incurable disease and patients are likely to require long-term treatment’.1

Shelagh McKinley, Head of Patient Advocacy, Myeloma UK said: “This approval is really good news for patients in Scotland and their families. We know from our research that keeping their myeloma under control is the most important thing for patients. Having access to daratumumab in combination with bortezomib and dexamethasone, and benefiting from the improved remission it delivers, is therefore hugely welcome. It is also good to see this combination being available to patients early in the treatment pathway where more patients can benefit.”

Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy at Janssen UK, said: “We are delighted that the SMC has recommended daratumumab plus bortezomib and dexamethasone for routine access to myeloma patients in Scotland after only one other treatment has been used and proven ineffective. This recommendation fulfils the previously unmet need for myeloma patients in Scotland that have already had one prior treatment.”

 

-ENDS-

About daratumumab[11]

The licensed indications for daratumumab are: 

  • In combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
  • As monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
  • 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.

More information can be found within daratumumab’s Summary of Product Characteristics, available atwww.medicines.org.uk/emc/medicine/32088

 

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Healthcare professionals are asked to report any suspected adverse events via the MHRA. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Limited on 01494 567447 or at dsafety@its.jnj.com.

 

Safety profile of daratumumab across all indications11

The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, muscle spasms, pyrexia, cough, neutropenia, thrombocytopenia, anaemia, peripheral sensory neuropathy and upper respiratory tract infection. Serious adverse reactions were pneumonia, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, diarrhoea and atrial fibrillation.

 

About multiple myeloma

Myeloma is a blood cancer of cells found in the bone marrow, specifically the “plasma cells”.7 Although treatment may result in remission, unfortunately patients will relapse as there is currently no cure. While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include weak bones, weakness, anaemia or repeated infections.[12] Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.10

 

Prevalence of multiple myeloma in Scotland

Each year in Scotland around 450 new cases of myeloma are diagnosed and the disease accounts for 1.4 percent of all new cancer cases.4 The 5-year survival rates for adults with myeloma in Scotland between 2007 and 2011 were approximately 47%.[13] The latest mortality data from ISD Scotland show that there were 266 deaths from myeloma in Scotland in 2017.8

 

About the CASTOR trial

MMY3004 (CASTOR) is a pivotal phase III, multicentre, randomised, open-label, active-controlled study comparing daratumumab) plus bortezomib and dexamethasone and bortezomib and dexamethasone, among patients with RRMM who had received at least one prior line of therapy.2

Data from the MMY3004 (CASTOR) trial showed that the addition of daratumumab significantly improved PFS, the study’s primary endpoint, with a 61 percent reduction in the risk of disease progression or death, compared to bortezomib and dexamethasone alone, at a median follow-up of 7.4 months.2

In updated efficacy data after median follow-up of 40 months (>2 years after interim analysis), it showed that in patients who had received one prior line of therapy, median PFS was 27 months for DVd versus 7.9 months for Vd (HR, 0.22; 95% CI, 0.15-0.32; P <0.0001). [14]

 

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/uk. Follow us at www.twitter.com/JanssenUK.  Janssen-Cilag Limited is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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