NICE recommends Sarclisa® (isatuximab) for patients with multiple myeloma, an incurable progressive blood cancer1

 

 

 

 

READING, UK – 15th OCTOBER 2020 – 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.
1
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.”
Date of preparation: October 2020
Document number: MAT-GB-2002766 (v1.0)
An estimated 5,700 people in the UK are diagnosed with multiple myeloma each year, the
equivalent to 15 people each day.
4 There are approximately 3,000 multiple myeloma
related deaths each year, with almost half of patients dying within five years of diagnosis.
4
Multiple myeloma patients experience frequent relapses and the cancer can become
resistant to available treatments, making it much harder to control.5
“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).
2 Overall, isatuximab showed an additional 5.0 months without disease
progression.
2
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.2 Sanofi is proud that through working with NICE, NHS England and the Cancer
Drugs Fund, eligible patients can now benefit from this treatment.
“At Sanofi Genzyme we are driven by all the loved ones taken by cancer, and all
those still facing it. We believe everyone affected by cancer deserve more – more
options, more support and more life,” said Nicole Farmer, General Manager, UK &
Ireland, Sanofi Genzyme. “We are therefore delighted at the recognition and
recommendation from NICE, meaning we are able to make a new treatment
option accessible to patients, offering a chance to delay disease progression.”
About ICARIA-MM
The NICE FAD is based on a cohort of patients from the pivotal ICARIA-MM trial who
received three prior lines of anti-myeloma treatment, including lenalidomide and a
proteasome inhibitor.2
ICARIA-MM is the first randomised Phase 3 trial to report results
evaluating an anti-CD38/pomalidomide/dexamethasone combination. It was an openlabel, multi-centre trial evaluating isatuximab in combination with pom-dex versus pomdex alone in patients with RRMM.2 The study enrolled 307 patients with RRMM across
102 hospitals spanning 24 countries, including sites in the UK.
2
Date of preparation: October 2020
Document number: MAT-GB-2002766 (v1.0)
About isatuximab
Isatuximab is a monoclonal antibody (also known as a mAb) that binds to a specific site
on a protein called CD38, a high amount of which is present on the surface of MM cells.
By binding to the CD38 protein, isatuximab helps the body’s immune system target and
destroy the cancerous cell.2
Isatuximab is the first monoclonal antibody therapy approved in Europe to be used in
combination with pom-dex for the treatment of RRMM. It was granted Marketing
Authorisation in the European Union on 30 May 2020.6
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent illness with vaccines, provide
innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 employees in 100 countries, Sanofi is transforming scientific innovation into
healthcare solutions around the globe.
Sanofi, Empowering Life.
Media Relations Contact
Claire Whitmarsh
Sanofi UK & Ireland
Tel.: 07935 503 416
claire.whitmarsh@sanofi.com
Adverse events
Adverse events should be reported. Reporting forms and information can be found at
yellowcard.mhra.giv.uk. Adverse events should also be reported to Sanofi.
Opening office hours: 09.00 – 17.00 (Monday to Thursday) 09.00 – 16.00 (Friday)
Tel.: +44 (0) 800 090 2314. Alternatively, send via email to UK-drugsafety@sanofi.com
References
1 NICE. Final appraisal document. Isatuximab with pomalidomide and dexamethasone for treating relapsed and
refractory multiple myeloma. October 2020
2 Attal M, Richardson PG, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide
and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised,
multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096–2107.
3 Myeloma UK. Infopack for newly diagnosed myeloma. Available at: https://www.myeloma.org.uk/wpcontent/uploads/2018/05/Myeloma-UK-Infopack-for-newly-diagnosed-myeloma-patients.pdf. Accessed October 2020.
Date of preparation: October 2020
Document number: MAT-GB-2002766 (v1.0)
4 Myeloma UK Impact report, July 2018. Available at: https://www.myeloma.org.uk/wpcontent/uploads/2018/10/Myeloma-UK-Impact-Report-2018.pdf. Accessed October 2020.
5
Infopack for relapsed and/or refractory myeloma patients. Myeloma UK. Available at:
https://www.myeloma.org.uk/wp-content/uploads/2018/05/Myeloma-UK-Infopack-for-relapsed_refractorymyelomapatients.pdf. Accessed October 2020.
6 European Medicines Agency. Sarclisa. Available at:
https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa. Accessed October 2020

Parag Narang

Parag Narang is a Digital Marketing Associate at PharmaShots, a division of Octavus Consulting. He manages the digital marketing as well as the designing ideas for PharmaShots. He has a degree in Bachelor of Business Administration along with Post Graduate Program in Management (Marketing). Parag manages all the social media handles very well since he has a good experience in Marketing & Sales.

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