The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Sarclisa® (isatuximab), in combination with existing treatment (pomalidomide and dexamethasone, or pom-dex), for adults with relapsed/refractory* multiple myeloma (RRMM) who have received three prior lines of treatment and at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last treatment.[v]
This recommendation has been welcomed by both the patient and medical communities at a time when cancer patients, one of the most vulnerable groups, are facing a marked impact due to the global COVID-19 pandemic, with delays in treatment and services.
“We’re delighted that NICE has recommended isatuximab. Myeloma remains incurable and is a hugely challenging cancer to live with. It is vital for patients to know that treatments are there waiting for them when they relapse,” said Laura Kerby, CEO, Myeloma UK. “The limited therapies available for patients at later stages of the disease mean that increasing options at this point in the treatment pathway is crucial. Having access to a treatment that can provide valuable extra months without disease progression offers hope that people will have more time with their loved ones.”
An estimated 5,700 people in the UK are diagnosed with multiple myeloma each year,the equivalent to 15 people each day.[viii] There are approximately 3,000 multiple myeloma related deaths each year, with almost half of patients dying within five years of diagnosis.[viii] Multiple myeloma patients experience frequent relapses and the cancer can become resistant to available treatments, making it much harder to control.[ix]
“Despite a growing understanding of multiple myeloma, it still remains incurable and carries a significant disease burden among the older adult patient population,” said Professor Kwee Yong, Consultant in Haematology, University College Hospital, London. “Trials have shown that isatuximab, in combination with pomalidomide and dexamethasone, offers a significant advantage over treatments which were – until now – considered the standard of care for adults with relapsed and refractory multiple myeloma. Today’s recommendation, therefore, provides us with an urgently needed new therapeutic option for this group of hard-to-treat patients, for whom life expectancy and prognosis is poor.”
The ICARIA-MM trial demonstrated that isatuximab in combination with pomalidomide and dexamethasone showed a reduction in risk of disease progression or death in adults by 40%, potentially extending the length of time a patient can live without their cancer progressing (progression-free survival) to 11.5 months, compared to 6.5 months when treated with pomalidomide and dexamethasone alone (HR 0.596 95% CI 0.44–0.81 P=0.001).[vi] Overall, isatuximab showed an additional 5.0 months without disease progression.[vi]
Isatuximab was the first treatment in multiple myeloma to be awarded a Promising Innovative Medicine designation and made available before approval via the Early Access to Medicine Scheme (EAMS). The addition of isatuximab to pomalidomide and dexamethasone was well tolerated, with no increase in treatment discontinuation or incidence of fatal events compared with that in the pomalidomide and dexamethasone group.[vi] Sanofi is proud that, through working with NICE, NHS England and the Cancer Drugs Fund, eligible patients can now benefit from this treatment.
 Sonneveld P and Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica 2016 Apr; 101(4): 396–406.
 NICE. Final appraisal document. Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma. October 2020.
 Myeloma UK. Infopack for newly diagnosed myeloma. Available at: https://www.myeloma.org.uk/wp-content/uploads/2018/05/Myeloma-UK-Infopack-for-newly-diagnosed-myeloma-patients.pdf. Accessed October 2020.
 Myeloma UK Impact report, July 2018. Available at: https://www.myeloma.org.uk/wp-content/uploads/2018/10/Myeloma-UK-Impact-Report-2018.pdf. Accessed October 2020.