Today, a piece of news took over health portals around the world: for the first time in European Union history, a cancer treatment was approved to be applied at home, with a portable injector. But what exactly is this? Who can use it? Will it come to Brazil? Let's explain everything carefully.

What is Sarclisa?

Sarclisa is the brand name of the active ingredient isatuximab, a medication of the monoclonal antibody type.

This name might sound intimidating, but the concept is simple: it is a protein produced in the laboratory that mimics the natural defenses of our body, teaching the immune system to recognize and attack diseased cells.

  • Developer: French pharmaceutical company Sanofi.
  • Launch: Launched on the market in 2020.
  • Global reach: More than 70,000 patients worldwide have already received the treatment, with approval in approximately 60 countries — including Brazil, by ANVISA.

Which cancer does it treat?

Sarclisa treats multiple myeloma, a type of blood cancer that affects cells in the bone marrow (the inner part of our bones, responsible for producing blood cells).

It is indicated for two main groups of patients:

  1. People with relapsed or refractory multiple myeloma: that is, whose cancer returned after treatment or did not respond well to conventional therapies. In this case, Sarclisa is used in combination with other already established medications.
  2. Newly diagnosed patients who cannot undergo bone marrow transplant: a more recent indication, approved after a Phase 3 study called IMROZ, which showed significant improvement in the time the disease remains controlled.

What changed today?

Until now, Sarclisa was applied exclusively via intravenous route — that infusion requiring a chair in a hospital or clinic and can last hours.

The novelty approved by the European Union is the subcutaneous version: a simple injection applied under the skin, using a portable injector (similar to a pen) or by conventional manual injection.

Impact on patient routine

  • Convenience: Instead of going to the hospital for each session, the patient can receive the application at home or in smaller outpatient clinics.
  • Physical and emotional relief: For many people with cancer, reducing travel and time spent inside hospitals represents a huge gain in quality of life.
  • Flexibility: The change offers greater flexibility in patient care without compromising treatment effectiveness.

What stage is the study of this new version in?

It is important to understand that intravenous Sarclisa has already passed through all study phases and is fully approved. What was approved in Europe is a new form of administration of the same medication already known and tested.

💡 Note: We are not talking about an experimental therapy. The medication itself is established; the change occurs strictly in the form of application.

Where is it already approved and what is still needed?

The version with portable injector has just received the green light from the European Union. Other global markets are still analyzing the scenario:

  • United States (FDA): The decision has been delayed and should come out by the end of July 2026.
  • Japan and China: They are also in the regulatory analysis phase.
  • Brazil: The intravenous version already has ANVISA approval. The subcutaneous version with portable injector has not yet been submitted for analysis by Brazilian regulators and currently has no defined timeline.

How much does it cost and who pays for it?

This is the point that usually generates the most questions. Sarclisa is an expensive medication: in Brazil, each box can exceed R$ 6,000, and treatment involves multiple cycles.

  • Health Insurance Plans: Brazilian legislation guarantees mandatory coverage by health insurance plans for medications approved by ANVISA with indication in the package insert. Therefore, if your doctor prescribed it and the medication is approved for that indication, the plan is obligated to cover it. In case of illegal denial, it is possible to seek legal action.
  • Through the SUS: The incorporation configuration has not yet been defined for all indications. Patients without health insurance can check availability in medication access programs or seek guidance directly from SUS oncology services.

Who can use it?

The treatment is indicated for adults with a diagnosis of multiple myeloma, in specific situations determined by an oncologist or hematologist physician.

It is not a medication for general use. The indication, combination with other treatments, and follow-up must be done exclusively by a specialist.

And Brazil, is it left out?

Not necessarily, but it requires patience. Intravenous Sarclisa already exists here. The version with portable injector approved in Europe still needs to be submitted to ANVISA for analysis. This process usually takes months or years after approval in major international regulatory markets.

What we can say with clarity: the treatment itself is not a novelty, and those who need it can talk to their doctor about the options already available in the country.

The summary you need to know

  • Consolidation: Sarclisa is an already established treatment for multiple myeloma, approved in 60 countries since 2020.
  • Innovation: The novelty is the version with portable injector approved in the European Union — the first of its kind for cancer treatment.
  • Autonomy: It allows application at home or in an outpatient clinic, without the need for long hospital stays.
  • National Scenario: The medication is already approved in Brazil by ANVISA in the intravenous version. The subcutaneous version still awaits submission and regulatory analysis here.
  • Right to Treatment: Health insurance plans are obligated to cover medications approved by ANVISA upon medical prescription as indicated in the package insert.
  • Medical Criterion: Only a specialist physician can indicate whether this treatment is appropriate for each case.

Legal Notice

This content is exclusively informative and educational in nature, based on public information available as of June 8, 2026. It does not replace, under any circumstances, a medical consultation. If you or someone close to you has a diagnosis of multiple myeloma or any other type of cancer, seek a trusted doctor for individualized guidance on the best treatment options available for each case.

Dr. Rebeca Soares Andrade CRM-GO 39335