Sanofi's CD38 Antibody Sarclisa Recommended by NICE for Relapsed/Refractory Multiple Myeloma in UK

November 27, 2020 /BioValleyBIOON/ -- The UK's National Institute for Health and Care Excellence (NICE) has recently recommended the use of Sanofi’s CD38-targeted antibody drug Sarclisa (isatuximab), in combination with pomalidomide and dexamethasone (pom-dex), within the National Health Service (NHS) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). This recommendation applies to patients who have previously received lenalidomide and a proteasome inhibitor, and whose disease progressed after the last therapy if they have received three prior lines of treatment.

This scheme will provide funding through the Cancer Drugs Fund (CDF) in the UK, offering a new treatment option for patients with relapsed/refractory multiple myeloma (RRMM). Multiple myeloma (MM) is a type of blood cancer, with approximately 5,700 new cases diagnosed annually in the UK, making it the fifth most common cancer type. It is estimated that around 500 people in the UK each year will benefit from NICE’s recommendation.

Meindert Boysen, Deputy Chief Executive of NICE and Director of the Centre for Health Technology Evaluation, stated: “Our independent evaluation committee has recognized the need for additional treatment options for patients with difficult-to-treat multiple myeloma whose disease has relapsed or become refractory to prior therapies. Data reviewed by our committee indicate that the Sarclisa plus pomalidomide and dexamethasone regimen can delay disease progression and extend patient survival compared with current standard treatments. Access to this regimen will be provided through the Cancer Drugs Fund (CDF), offering a fourth-line treatment option. Meanwhile, we are collecting ongoingClinical Trialand NHS data to determine whether it is cost-effective.”

Due to the limitations of clinical data, this treatment cannot be recommended for routine use in the NHS because its cost-effectiveness estimates are uncertain.However, collecting more data from an ongoing trial and from NHS practice will help address some uncertainties, meaning it can be recommended for use under the Cancer Drugs Fund (CDF) program.

The active pharmaceutical ingredient of Sarclisa, isatuximab, is an IgG1 chimeric monoclonal antibody that targets a specific epitope on the CD38 receptor of plasma cells, triggering multiple unique mechanisms of action, including the induction of programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly expressed on multiple myeloma (MM) cells and is a target in MM and other malignancies.TumorCell surface receptor targets for antibody therapy.

Sarclisa received U.S. approval in early March this yearFDAApproved; received EU approval in June this year, in combination with pom-dex, for adult patients with RRMM who have previously received at least two therapies (including lenalidomide and a proteasome inhibitor).Data from the first randomized phase III trial (ICARIA-MM) showed that Sarclisa in combination with pom-dex significantly reduced the risk of disease progression or death by 40% compared with pom-dex therapy.

Multiple myeloma (MM) is the second most common hematologic cancer worldwide, with new cases annuallyDiagnosisMore than 138,000 cases have been reported. In Europe, approximately 40,000 new cases are diagnosed annually; in the United States, 32,000 cases are diagnosed each year. Despite the availability of treatments, MM remains an incurable malignancy.Tumor, which is associated with a significant burden on patients. As multiple myeloma (MM) is incurable, most patients will eventually relapse and become refractory to currently available therapies. The combination of Sarclisa with pomalidomide and dexamethasone (pom-dex) regimen will provide an important new treatment option for these patients.

Upon its market launch, Sarclisa will become the first direct competitor to Johnson & Johnson’s blockbuster CD38-targeted therapy, Darzalex, which was launched in 2015 and achieved global sales of $2.998 billion in 2019, representing a 48.0% year-over-year increase. Analysts at Jefferies, a Wall Street investment bank, project that Sarclisa’s annual peak sales will exceed $1 billion following its commercialization.

Currently, Sanofi is advancing multiple Phase III clinical studies to evaluate isatuximab in combination with currently available standard therapies for the treatment of patients with RRMM or newDiagnosisMM patients. (Bioon.com)

Original Source: New option for people with difficult-to-treat multiple myeloma is recommended for use in Cancer Drugs Fund by NICE