Today, a piece of news captured the attention of health portals around the world: for the first time in the history of the European Union, a cancer treatment was approved to be administered at home, using a portable injector. But what exactly is this? Who can use it? Will it arrive in Brazil? Let us explain everything calmly.

What is Sarclisa?

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

This name may be daunting, but the concept is simple: it is a protein produced in the laboratory that mimics the natural defences of our body, teaching the immune system to recognise 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 has returned after treatment or did not respond well to conventional therapies. In this case, Sarclisa is used in combination with other established medications.
  2. Newly diagnosed patients who cannot undergo bone marrow transplant: a more recent indication, approved following a Phase 3 study called IMROZ, which showed significant improvement in the time the disease remains controlled.

What changed today?

Until now, Sarclisa was administered exclusively by intravenous route — that infusion which requires a chair in a hospital or clinic and may last for hours.

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

Impact on patient routine

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

What stage is the study of this new version at?

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 medicine itself is well-established; the change occurs strictly in the form of application.

Where is it already approved and what still remains?

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

  • United States (FDA): The decision has been postponed and should be released 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 regulatory analysis in Brazil and currently has no defined date.

How much does it cost and who pays?

This is the point that usually generates the most questions. Sarclisa is a high-cost medication: in Brazil, each box can exceed R$ 6,000, and the 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 has prescribed it and the medication is approved for that indication, the plan is obliged to cover it. In case of illegal denial, it is possible to seek legal remedy.
  • Through the SUS: The incorporation arrangement has not yet been defined for all indications. Patients without health insurance can check availability in medication access programmes or seek guidance directly in SUS oncology services.

Who can use it?

The treatment is indicated for adults with a diagnosis of multiple myeloma, in specific situations determined by the medical oncologist or haematologist.

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

And Brazil, is it left out?

Not necessarily, but patience is required. 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 state clearly: the treatment itself is not a novelty, and those who need it can discuss with their doctor the options already available in the country.

The summary you need to know

  • Well-established: Sarclisa is a well-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 the treatment of a cancer.
  • Autonomy: It allows administration at home or in an outpatient clinic, without the need for long hospital sessions.
  • National Scenario: The medication is already approved in Brazil by ANVISA in the intravenous version. The subcutaneous version is still awaiting submission and regulatory analysis here.
  • Right to Treatment: Health insurance plans are obliged to cover medications approved by ANVISA upon medical prescription with indication in the package insert.
  • Medical Criterion: Only a specialist physician can indicate whether this treatment is appropriate for each case.

Legal Disclaimer

This content is exclusively informative and educational in nature, based on publicly available information as of 8 June 2026. It does not substitute, 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, consult a trusted physician for individualised guidance on the best treatment options available for each case.

Dr Rebeca Soares Andrade CRM-GO 39335