What is SARCLISA and how does it work?
SARCLISA (isatuximab-irfc) is an anti-CD38 monoclonal antibody. Unlike traditional chemotherapy, it's a targeted immunotherapy that uses the body's immune system to fight cancer. SARCLISA targets the CD38 protein, found in high amounts on multiple myeloma cells.
By binding to CD38, SARCLISA works in multiple ways to destroy cancer cells:
- Directly inducing programmed cell death (apoptosis).
- Activating the immune system, including NK cells, to attack cancer cells (ADCC and CDC).
- Boosting the immune response against myeloma cells.
Approved Indications and Combination Therapies
SARCLISA is approved for adults with multiple myeloma and is always used in combination with other drugs. The specific combination depends on previous treatments and eligibility for stem cell transplant. Information regarding FDA-approved combinations can be found on the {Link: Sanofi website https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-20-22-36-34-2949916}.
SARCLISA vs. DARZALEX
DARZALEX (daratumumab) is another anti-CD38 monoclonal antibody. While both target CD38, they differ in their specific binding sites and are used in various combinations and treatment stages. A comparison is provided below:
| Feature | SARCLISA (isatuximab) | DARZALEX (daratumumab) |
|---|---|---|
| Drug Class | Anti-CD38 Monoclonal Antibody | Anti-CD38 Monoclonal Antibody |
| Target | Binds to a specific epitope on the CD38 receptor. | {Link: Myeloma.org https://www.myeloma.org/sarclisa-isatuximab-irfc} |
| FDA Approval Year | 2020 (initial approval). | 2015 (initial approval). |
| Indications | Approved for newly diagnosed (non-transplant) and relapsed/refractory MM in combination with other agents. | Approved for a wider range of MM settings, including various lines of therapy and as monotherapy. |
| Administration | {Link: Myeloma.org https://www.myeloma.org/sarclisa-isatuximab-irfc} | Subcutaneous (SQ) and Intravenous (IV) formulations are available. |
| Key Trial Data (Example) | IMROZ trial showed significant improvement in PFS for non-transplant NDMM patients. | PERSEUS trial showed improved outcomes in transplant-eligible NDMM. |
| Interference with Tests | Can interfere with blood bank serological tests. | Can interfere with blood bank serological tests. |
Common and Serious Side Effects of SARCLISA
SARCLISA can cause side effects. Patients are monitored during treatment. Common side effects in combination therapy include:
- Infusion-related reactions (IRRs), such as chills, cough, fever, shortness of breath, or nasal congestion, often managed with premedication.
- Increased risk of infections like upper respiratory tract infections and pneumonia.
- Low blood cell counts, including neutropenia, anemia, and thrombocytopenia.
- Fatigue and weakness.
- Gastrointestinal issues like diarrhea and constipation.
- Other effects such as back pain, muscle/bone pain, trouble sleeping, and high blood pressure.
Serious side effects can occur, and patients should report any unusual symptoms. Potential for new cancers and interference with blood tests are also important.
Important Considerations for Patients
- SARCLISA can affect certain blood tests, including those for blood transfusions. Patients should inform all healthcare providers, including blood banks, about their treatment.
- The drug can harm a fetus. Females of reproductive potential must use effective birth control during and for five months after treatment.
- Patients should take steps to prevent infections. An antiviral may be prescribed to prevent shingles.
- Premedication helps manage infusion reactions, and colony-stimulating factors may be used for low blood counts.
Conclusion
SARCLISA (isatuximab) is an important targeted therapy for multiple myeloma. As an anti-CD38 monoclonal antibody, it works with the immune system to attack cancer cells. Its use in specific combinations has shown efficacy in both newly diagnosed and relapsed/refractory multiple myeloma, offering a valuable treatment option, especially for patients not eligible for transplant. While side effects are possible, careful monitoring and management strategies help patients. Ongoing research continues to improve outcomes for multiple myeloma patients with therapies like SARCLISA. For more detailed information, consult the official prescribing information on the {Link: FDA website https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf}.
