dm+d

38720311000001103

Refrigerated Storage

SarclisaSanofi

Sanofi
Sarclisa
Concentrate for solution for infusion

Contact Sanofi in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

12 November 2021
London MI Service

New Medicines

SarclisaMultiple myeloma (MM), relapsed or refractory - third-line or greater in combination with pomalidomide and dexamethasone

Information

Sarclisa
New molecular entity
Sanofi
Sanofi

Development and Regulatory status

Launched
Launched
Launched
August 2020
Yes
Nov 21This product is no longer an orphan medicine for this indication in the EU. It was withdrawn from the Union Register of orphan medicinal products by the European Commission in April 2020 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation [19].
Oct 20Sarclisa is also available in the US [18].
Aug 20Available in UK. Conc for soln for inf in vial: 100mg/5ml, 1=£506.94; 500mg/25ml, 1=£2534.69 [17].
Jun 20Approved in EU [15].
Mar 20Recommended for EU approval by CHMP - the full indication is "in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI) and have demonstrated disease progression on the last therapy.” The medicine should be administered by a healthcare professional, in an environment where resuscitation facilities are available [14].
Mar 20Approved in US [13].
Dec 19Granted EAMS status by MHRA for treatment of adult patients with relapsed and refractory multiple myeloma, in combination with pomalidomide and dexamethasone [12].
Jul 19Filed in EU via centralised procedure [10].
Jul 19US FDA accepts BLA for isatuximab in treatment of RRMM for review, with a target action date of 30/4/20 [9].
Jan 19Filings planned for 2019 [6].
Mar 18US filing planned for 2018; presume EU will follow [4].
Nov 17NCT02990338 includes centres in EU and RoW [4].
Apr 17Has orphan drug status in EU & US [2].

Category

A non-TAP antibody consisting of a type II transmembrane glycoprotein CD38-targeting antibody. The CD38 antigen is expressed in numerous haematological malignancies.
Multiple myeloma is the second most common haematological cancer. It is responsible for 15-20% of deaths from haematological cancer and about 2% of all deaths from cancer. The incidence in Europe is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [1].
Multiple myeloma (MM), relapsed or refractory - third-line or greater in combination with pomalidomide and dexamethasone
Intravenous infusion

Further information

Yes

Trial or other data

Nov 19Results of PIII ICARIA-MM trial are published in The Lancet [11].
Jun 19Topline results for isatuximab in combination with standard of care were presented at ASCO conference. Tumour shrinkage was reported in 60% isatuximab-combination patients compared to 35% patients taking standard of care (pomalidomide and dexamethasone). Progression free survival has been increased from 6.5 months to 11.5 months. Treatment with isatuximab combination is thought to work faster, with a response seen after median 35 days compared to 58 days with standard of care alone [8].
Feb 19Positive topline data announced from PIII ICARIA-MM trial (n=307) of weekly i.v. isatuximab 10mg/kg for 4 weeks, then every other week for 28-day cycles in combination with std doses of pomalidomide and dexamethasone (standard of care [SOC}) for the duration of treatment. Compared with standard of care alone, isatuximab met the primary endpoint of prolonging progression free survival (PFS) in pts treated with isatuximab plus SOC vs. SOC alone. [7]
Dec 17In the PIII ICARIA-MM trial (NCT02990338), collection of PFS data now expected to complete Dec 20 [5].
Apr 17In the PIII ICARIA-MM trial (NCT02990338), collection of PFS data expected to complete May 18 [3].
Apr 17Sanofi initiates the PIII ICARIA-MM trial of isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone, in patients with relapsed and refractory multiple myeloma. Progression-free survival will be the primary endpoint and overall response rate and overall survival will be the secondary endpoint of the study. The randomised, open label trial will enrol approximately 300 patients around the world [2].

Evidence based evaluations

SarclisaMultiple myeloma (MM) in patients previously treated with at least 1 therapy - in combination with carfilzomib and dexamethasone

Information

Sarclisa
Licence extension / variation
Sanofi
Sanofi

Development and Regulatory status

Launched
Launched
Launched
June 2021
Yes
Nov 21This product is no longer an orphan medicine for this indication in the EU. It was withdrawn from the Union Register of orphan medicinal products by the European Commission in April 2020 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation [13].
Jun 21Licence extension approved in UK for use in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy [12].
Apr 21Approved in EU [11]
Apr 21Approved in US for for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM), who have received one to three prior lines of therapy [10]
Feb 21Recommended for EU approval by CHMP - the additional indication is "in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (see section 5.1)" [9].
Oct 20Data from IKEMA has been filed to the FDA and EMA [8].
Oct 18Has orphan drug status in US & EU [3].
Jul 18Filings planned for 2020 [4].

Category

A non-TAP antibody consisting of a type II transmembrane glycoprotein CD38-targeting antibody. The CD38 antigen is expressed in numerous haematological malignancies.
Multiple myeloma is the second most common haematological cancer. It is responsible for 15-20% of deaths from haematological cancer and about 2% of all deaths from cancer. The incidence in Europe is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [1].
Multiple myeloma (MM) in patients previously treated with at least 1 therapy - in combination with carfilzomib and dexamethasone
Intravenous infusion

Further information

Yes

Trial or other data

May 22Latest results from the PIII IKEMA trial evaluating isatuximab in combination with carfilzomib and dexamethasone (Kd) demonstrated a median progression free survival (mPFS) of 35.7 months (Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 25.8 to 44.0; n=179), compared to 19.2 months in patients treated with Kd alone (95% CI: 15.8 to 25.1; n=123), as evaluated by an Independent Review Committee [14]
Jun 20Interim results of PIII IKEMA trial presented at the European Hematology Association (EHA) Virtual Congress. Isatuximab added to carfilzomib and dexamethasone (Sarclisa combination therapy) reduced the risk of disease progression or death by 47% (hazard ratio 0.531, 99% CI 0.318-0.889, p=0.0007, n=179) compared to standard of care carfilzomib and dexamethasone (Kd) in patients (n=123) with relapsed multiple myeloma (MM). Sarclisa combination therapy compared to Kd alone showed a treatment benefit consistent across multiple subgroups. Median progression free survival (PFS) for Kd was 19.15 months. Median PFS for patients receiving Sarclisa combination therapy had not been reached at the time of the pre-planned interim analysis [7].
May 20Interim analysis of PIII IKEMA trial in 302 patients with relapsed multiple myeloma across 69 centers spanning 16 countries found significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone [6].
Nov 19PIII IKEMA trial is no longer recruiting; collection of primary outcome data should complete Nov 20 [5].
Oct 17PIII IKEMA trial to demonstrate the benefit of isatuximab, carfilzomib and dexamethasone combination, compared with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma, previously treated with one to three lines of therapy starts (NCT03275285). 300 patients will be recruited from sites around the world including in the US & EU (plus UK). Collection of primary outcome data (progression-free survival) is due to complete Aug 23 [2].

Evidence based evaluations

SarclisaMultiple myeloma (MM) - first-line in combination with bortezomib, lenalidomide and dexamethasone in patients not eligible for transplant

Information

Sarclisa
Licence extension / variation
Sanofi
Sanofi

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials
Yes

Category

A non-TAP antibody consisting of a type II transmembrane glycoprotein CD38-targeting antibody. The CD38 antigen is expressed in numerous haematological malignancies.
Multiple myeloma is the second most common haematological cancer. It is responsible for 15-20% of deaths from haematological cancer and about 2% of all deaths from cancer. The incidence in Europe is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [1].
Multiple myeloma (MM) - first-line in combination with bortezomib, lenalidomide and dexamethasone in patients not eligible for transplant
Intravenous infusion

Evidence based evaluations

SarclisaMultiple myeloma (MM) - first-line induction in transplant-eligible patients in combination with bortezomib, lenalidomide and dexamethasone in patients eligible for transplant, followed by lenalidomide maintenance

Information

Sarclisa
Licence extension / variation
Sanofi
Sanofi

Development and Regulatory status

None
Phase III Clinical Trials
None
Yes

Category

A non-TAP antibody consisting of a type II transmembrane glycoprotein CD38-targeting antibody. The CD38 antigen is expressed in numerous haematological malignancies.
Multiple myeloma is the second most common haematological cancer. It is responsible for 15-20% of deaths from haematological cancer and about 2% of all deaths from cancer. The incidence in Europe is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [1].
Multiple myeloma (MM) - first-line induction in transplant-eligible patients in combination with bortezomib, lenalidomide and dexamethasone in patients eligible for transplant, followed by lenalidomide maintenance
Intravenous infusion