A Closer Look at Recent FDA Approvals for Multiple Myeloma
Pharmacists can educate patients about a pair of new treatment options for multiple myeloma approved by the FDA in March 2021.
Multiple myeloma is an uncommon cancer of the plasma cells that can cause a variety of complications, including thrombocytopenia, bone and calcium problems, infections, and renal dysfunction.1 According to the American Cancer Society, more than 34,000 new cases of multiple myeloma will be diagnosed in 2021 and approximately 12,000 deaths are expected to occur this year.1 Pharmacists can educate patients about 2 new treatment options for multiple myeloma.
New Multiple Myeloma Treatment Options
The FDA approved idecabtagene vicleucel (Abecma) on March 27, 2021. It is the first cell-based gene therapy to treat adult patients with relapsed or refractory multiple myeloma after at least 4 prior different types of treatment.2 Orphan drug and breakthrough therapy designations have also been granted to idecabtagene vicleucel by the FDA.2
Idecabtagene vicleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy, which works by reprogramming the T cells to destroy multiple myeloma cells.2 FDA approval for idecabtagene vicleucel was based on a multicenter study that showed 72% of patients partially or completely responded to the treatment.2
Idecabtagene vicleucel is administered as a single-dose for intravenous infusion (IV), and it carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome, which can all be fatal.3
Because of the risk of CRS and neurologic toxicities, idecabtagene vicleucel is available through a restricted program under a Risk Evaluation and Mitigation Strategy called Abecma REMS, which includes training for all health care professionals involved in prescribing, administering, and dispensing the medication.3
Isatuximab (Sarclisa) is a monoclonal antibody that received FDA approval March 31, 2021, in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1-3 prior different types of therapies.4 This marks isatuximab’s second FDA approval for multiple myeloma treatment.4
The FDA approval was based on positive results from the phase 3 IKEMA trial, which demonstrated that isatuximab reduced the risk of disease progression or death by 45% (p = 0.0032) compared to standard of care.4 Common adverse effects include respiratory tract infections, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, shortness of breath, bronchitis, and cough.
The dose of isatuximab is 10 mg/kg actual body weight administered as an IV infusion in combination with carfilzomib and dexamethasone, and each treatment cycle is a 28-day period (see Table).5
Table: Isatuximab Dosing Schedule5
- American Cancer Society.Key statistics about multiple myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html. Accessed June 19, 2021.
- FDA Approves First Cell-Based Gene Therapy for Adult Patients with Multiple Myeloma [news release].FDA; March 27, 2021.https://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-adult-patients-multiple-myeloma.Accessed June 19, 2021.
- Abecma.Prescribing information.Bristol Myers Squibb; 2021.https://packageinserts.bms.com/pi/pi_abecma.pdf.Accessed June 19, 2021.
- FDA Approves Sarclisa (isatuximab) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma [news release].Sanofi; March 31, 2021.https://www.sanofi.com/en/media-room/press-releases/2021/2021-03-31-23-15-00-2202919.Accessed June 19, 2021.
- Sarclisa.Prescribing information.Sanofi; 2021.https://products.sanofi.us/Sarclisa/Sarclisa.pdf.Accessed June 19, 2021.