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FDA Approves Sarclisa (Isatuximab-irfc) For Patients With Relapsed Refractory Multiple Myeloma

By: Press Release Reporter; Published: March 2, 2020 @ 2:42 pm | Comments Disabled

  • Sarclisa in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) sig­nif­i­cantly reduced the risk of dis­ease pro­gres­sion or death by 40% com­pared to pom-dex alone in a pivotal trial
  • FDA ap­­prov­al based on data from the only ran­dom­ized Phase 3 trial (ICARIA-MM) to eval­u­ate an anti-CD38 in com­bi­na­tion with pom-dex that has pre­sented results to date
  • Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the U.S.; approx­i­mately 32,000 Americans are diag­nosed with multiple myeloma each year

{{image}}Bridgewater, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has approved Sarclisa® (isatuximab-irfc) in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (pom-dex) for the treat­ment of adults with re­lapsed re­frac­tory multiple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. Sarclisa is ex­pec­ted to be avail­able to patients in the U.S. shortly.

Sarclisa is a mono­clonal anti­body that binds to the CD38 re­cep­tor on multiple myeloma cells.

"Today's FDA ap­­prov­al of Sarclisa provides a new treat­ment option for patients with dif­fi­cult-to-treat multiple myeloma. These are patients whose dis­ease has returned or be­come resistant to their prior treat­ments," said Paul Hudson, Chief Executive Officer, Sanofi. "At Sanofi, we are focused on discovering and devel­op­ing med­i­cines that may change the practice of med­i­cine, and Sarclisa offers a poten­tial new standard of care in the United States. We con­tinue to eval­u­ate Sarclisa in a com­pre­hen­sive clin­i­cal pro­gram in multiple myeloma, as well as in other blood cancers and solid tumors."

Sarclisa Safety Profile and Efficacy in Difficult-to-Treat Patients

In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa com­bi­na­tion ther­apy) dem­onstrated a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion free sur­vival (PFS) with a median PFS of 11.53 months com­pared to 6.47 months with pom-dex alone (HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa com­bi­na­tion ther­apy also dem­onstrated a sig­nif­i­cantly greater over­all re­sponse­ rate com­pared to pom-dex alone (60.4% vs. 35.3%, p<0.0001).

"Most patients with multiple myeloma unfortunately relapse and be­come re­frac­tory to cur­rently avail­able ther­a­pies. Sarclisa used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone offers an im­por­tant new treat­ment option for patients in the United States living with this incurable dis­ease," said Paul Richardson, MD, prin­ci­pal in­ves­ti­ga­tor of ICARIA-MM, and clin­i­cal pro­gram leader and director of clin­i­cal re­search at the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "The pivotal ICARIA-MM trial was the first Phase 3 study of a CD38 anti­body in com­bi­na­tion with pom-dex to present results demonstrating sig­nif­i­cant clin­i­cal benefit in this setting. The study enrolled a broad pop­u­la­tion of patients with re­lapsed and re­frac­tory multiple myeloma that is particularly dif­fi­cult to treat and with poor prog­nosis, which is reflective of real-world practice."

The most common adverse reac­tions (occurring in 20% or more of patients) in patients who re­ceived Sarclisa com­bi­na­tion ther­apy were neu­tro­penia (96%), in­fusion-related reac­tions (39%), pneu­monia (31%), upper res­pira­tory tract in­fec­tion (57%) and diarrhea (26%). Serious adverse reac­tions that occurred in more than 5% of patients who re­ceived Sarclisa com­bi­na­tion ther­apy in­cluded pneu­monia (25.3%) and febrile neu­tro­penia (12.3%). Permanent dis­con­tinu­a­tion of Sarclisa com­bi­na­tion ther­apy due to an adverse reac­tion (Grades 3-4) occurred in 7% of patients, and 3% of patients dis­con­tinued due to an in­fusion-related reac­tion.

An Important New Option for Treating Multiple Myeloma

Sarclisa offers an in­tra­venous (IV) admin­istra­tion and is dosed at 10 mg/kg, in com­bi­na­tion with pom-dex, every week for four weeks and then every two weeks, until dis­ease pro­gres­sion or unacceptable toxicity. The first cycle is admin­istered in an in­fusion time of 200 min­utes, which can de­crease to 75 min­utes for the third cycle onwards. A treat­ment cycle is 28 days.

The U.S. list price (wholesale acquisition cost, or WAC) for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial. For a typical patient in the U.S., be­tween 70-80 kg (154-176 lbs), this correlates to a cost of $5,200 per in­fusion. Actual costs to patients are generally antic­i­pated to be lower as the list price does not reflect insurance coverage, copay sup­port, or fi­nan­cial assistance from patient sup­port pro­grams. Sanofi is com­mit­ted to responsible pricing while bringing inno­va­tive and valuable ther­a­pies to patients with sig­nif­i­cant unmet need.

Patients in the U.S. who have been prescribed Sarclisa may be eli­gible to enroll in the CareASSIST Patient Support Program, which provides reim­burse­ment sup­port and fi­nan­cial assistance to eli­gible patients. For more in­for­ma­tion, please call 1-833-WE+CARE (1-833-930-2273) or visit SanofiCareAssist.com/Sarclisa.

Multiple Myeloma Leads to Significant Disease Burden

Multiple myeloma is the second most common hema­to­logic malig­nan­cy,i affecting more than 130,000 patients in the United States; approx­i­mately 32,000 Americansii are diag­nosed with multiple myeloma each year. Despite avail­able treat­ments, multiple myeloma remains an incurable malig­nan­cy, and is asso­ci­ated with sig­nif­i­cant patient burden. As patients relapse, they can be­come re­frac­tory to ther­a­pies they have re­ceived. There is a need for new agents so that patients and physicians can have options as the dis­ease progresses over time. Re­lapsed (or recurrent) multiple myeloma means that the cancer returns after treat­ment or a period of remission. Since multiple myeloma does not have a cure, most patients will relapse at some point. Re­frac­tory multiple myeloma refers to cancer that does not respond to ther­apy.

About Sarclisa

Sarclisa is a mono­clonal anti­body (mAb) that binds to the CD38 re­cep­tor on multiple myeloma cells. It is designed to induce pro­grammed tumor cell death (apoptosis) and immuno­modu­la­tory activity. CD38 is highly and uniformly ex­pressed on multiple myeloma cells and cell surface re­cep­tors, making it a poten­tial target for anti­body-based thera­peutics such as Sarclisa.

Sarclisa has Orphan Drug Desig­na­tion status from the FDA and the European Medicines Agency (EMA). In the second quarter of 2019, the EMA ac­cepted for review the Marketing Authori­za­tion Application for use of Sarclisa in com­bi­na­tion with pom-dex for the treat­ment of cer­tain patients with RRMM. The safety and efficacy of Sarclisa has not been fully eval­u­ated by any regu­la­tory authority outside of the U.S.

Sarclisa con­tinues to be eval­u­ated in multiple ongoing Phase 3 clin­i­cal trials in com­bi­na­tion with current standard treat­ments for people with re­lapsed re­frac­tory or newly diag­nosed multiple myeloma. It is also under in­ves­ti­ga­tion for the treat­ment of other blood cancer types (hematologic malig­nan­cies) and solid tumors.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is SARCLISA?

SARCLISA is a prescription med­i­cine used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone to treat adults who have re­ceived at least 2 prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor, to treat multiple myeloma.

It is not known if SARCLISA is safe and effective in chil­dren.

Do not re­ceive SARCLISA if you have a history of severe allergic reac­tion to isatuximab-irfc or any of the ingredients in SARCLISA (see the list of ingredients in full Prescribing Information).

Before re­ceiv­ing SARCLISA, tell your health­care provider about all of your medical con­di­tions, in­clud­ing if you:

  • are pregnant or plan to be­come pregnant. SARCLISA may harm your unborn baby. You should not re­ceive SARCLISA during pregnancy.
    • Females who are able to be­come pregnant should use an effective method of birth con­trol during treat­ment and for 5 months after your last dose of SARCLISA. Talk to your health­care provider about birth con­trol methods that you can use during this time.

Tell your health­care provider right away if you think you are pregnant or be­come pregnant during treat­ment with SARCLISA.

  • are breastfeeding or plan to breastfeed. It is not known if SARCLISA passes into your breast milk. You should not breastfeed during treat­ment with SARCLISA.

Tell your health­care provider about all the med­i­cines you take, in­clud­ing prescription and over-the-counter med­i­cines, vitamins, and herbal supple­ments.

How will I re­ceive SARCLISA?

  • SARCLISA will be given to you by your health­care provider by in­tra­venous (IV) in­fusion into your vein.
  • SARCLISA is given in treat­ment cycles of 28 days (4 weeks), together with the med­i­cines poma­lido­mide and dexa­meth­a­sone.
    • In cycle 1, SARCLISA is usually given weekly.
    • Starting in cycle 2, SARCLISA is usually given every 2 weeks.

Your health­care provider will decide how long you should re­ceive SARCLISA.

  • If you miss any appoint­ments, call your health­care provider as soon as possible to reschedule your appoint­ment.
  • Your health­care provider will give you med­i­cines before each dose of SARCLISA to help reduce the risk of in­fusion reac­tions (make them less fre­quent and severe).

What are the possible side effects of SARCLISA?

SARCLISA may cause serious side effects, in­clud­ing:

  • Infusion reac­tions. Infusion reac­tions are common with SARCLISA and can sometimes be severe.
    • Your health­care provider will prescribe med­i­cines before each in­fusion of SARCLISA to help de­crease your risk for in­fusion reac­tions or to help make any in­fusion reac­tion less severe. You will be monitored for in­fusion reac­tions during each dose of SARCLISA.
    • Your health­care provider may slow down or stop your in­fusion, or com­pletely stop treat­ment with SARCLISA, if you have an in­fusion reac­tion.

Tell your health­care provider right away if you de­vel­op any of the fol­low­ing symp­toms of in­fusion reac­tion during or within 24 hours after an in­fusion of SARCLISA:

  • feeling short of breath
  • cough
  • chills
  • nausea
  • Decreased white blood cell counts. Decreased white blood cell counts are common with SARCLISA and cer­tain white blood cells can be severely de­creased. You may have an in­creased risk of getting cer­tain in­fec­tions, such as upper and lower res­pira­tory in­fec­tions.

Your health­care provider will check your blood cell counts during treat­ment with SARCLISA. Your health­care provider may prescribe an antibiotic or antiviral med­i­cine to help prevent in­fec­tion, or a med­i­cine to help in­crease your white blood cell counts during treat­ment with SARCLISA.

Tell your health­care provider right away if you de­vel­op any fever or symp­toms of in­fec­tion during treat­ment with SARCLISA.

  • Risk of new cancers. New cancers have hap­pened in people during treat­ment with SARCLISA. Your health­care provider will monitor you for new cancers during treat­ment with SARCLISA.
  • Change in blood tests. SARCLISA can affect the results of blood tests to match your blood type. Your health­care provider will do blood tests to match your blood type before you start treat­ment with SARCLISA. Tell all of your health­care providers that you are being treated with SARCLISA before re­ceiv­ing blood transfusions.

The most common side effects of SARCLISA in­clude:

  • lung in­fec­tion (pneumonia)
  • upper res­pira­tory tract infection
  • diarrhea
  • decreased red blood cell counts (anemia)
  • decreased platelet counts (thrombocytopenia)

These are not all the possible side effects of SARCLISA. For more in­for­ma­tion, ask your health­care provider or pharmacist.

Please see full Prescribing Information, in­clud­ing Patient Information.

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 people in 100 countries, Sanofi is transforming scientific inno­va­tion into health­care solu­tions around the globe.

Sanofi, Empowering Life

Sanofi Forward-Looking Statements

This press release con­tains for­ward-looking state­ments as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995, as amended. Forward-looking state­ments are state­ments that are not historical facts. These state­ments in­clude pro­jec­tions and esti­mates re­gard­ing the mar­ket­ing and other poten­tial of the prod­uct, or re­gard­ing poten­tial future revenues from the prod­uct. Forward-looking state­ments are generally identified by the words "expects", "antic­i­pates", "believes", "intends", "esti­mates", "plans" and similar ex­pres­sions. Although Sanofi's man­agement believes that the ex­pec­ta­tions reflected in such for­ward-looking state­ments are reason­able, in­vestors are cautioned that for­ward-looking in­for­ma­tion and state­ments are subject to various risks and un­cer­tainties, many of which are dif­fi­cult to predict and generally beyond the con­trol of Sanofi, that could cause actual results and devel­op­ments to differ ma­teri­ally from those ex­pressed in, or im­plied or pro­jected by, the for­ward-looking in­for­ma­tion and state­ments. These risks and un­cer­tainties in­clude among other things, unexpected regu­la­tory actions or delays, or gov­ern­ment reg­u­la­tion generally, that could affect the avail­a­bil­ity or commercial poten­tial of the prod­uct, the absence of guar­an­tee that the prod­uct will be commercially suc­cess­ful, the un­cer­tainties in­her­ent in re­search and devel­op­ment, in­clud­ing future clin­i­cal data and analysis of existing clin­i­cal data relating to the prod­uct, in­clud­ing post mar­ket­ing, unexpected safety, quality or manu­fac­tur­ing issues, com­pe­ti­tion in general, risks asso­ci­ated with intellectual property and any related future lit­i­ga­tion and the ultimate out­come of such lit­i­ga­tion, and volatile economic con­di­tions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, in­clud­ing those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended De­cem­ber 31, 2018. Other than as required by appli­cable law, Sanofi does not under­take any obli­ga­tion to update or revise any for­ward-looking in­for­ma­tion or state­ments.

References

[i] Kazandjian. Multiple myeloma epidemiology and sur­vival: A unique malig­nan­cy. Semin Oncol. 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004
[ii] National Cancer Institute. Myeloma Cancer Stat Facts. Available at: www.seer.cancer.gov/statfacts/html/mulmy.html. Accessed on De­cem­ber 12, 2019.

Source: Sanofi.


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