The Federal Regional Court of the 2nd Region (TRF2) ordered the supply of the drug Mitotane to patients in the Unified Health System (SUS) diagnosed with adrenocortical carcinoma (ACC) – a rare, aggressive cancer with no effective therapeutic alternative.
The court partially accepted the urgent provisional protection (injunction) requested by the Federal Public Ministry on appeal, after the denial of the request in the first instance. The decision recognizes the urgency of the situation and the concrete risk to the lives of patients who were without access to the medicine.
According to the MPF request. Mitotane, which has already been sold in Brazil under the trade name Lisodren, has been used to treat adrenocortical carcinoma since the 1960s and is recognized as the first and most effective therapeutic option for the disease. The drug is indicated both for cases of inoperable, metastatic or recurrent tumors and as adjuvant therapy, to reduce the risk of recurrence after surgery.
According to the MPF, there is no therapeutic alternative on the market with the same efficacy and safety, which makes the continuous supply of the drug essential within the scope of the SUS.
With the preliminary decision, the Union must present an action plan and detailed schedule to ensure that all SUS patients with a medical indication receive Mitotane continuously, avoiding interruption of treatment.
History
The MPF highlights that the crisis in the supply of Mitotano worsened in March 2022, when the company holding the registration in Brazil communicated to the National Health Surveillance Agency (Anvisa) the definitive discontinuation of the manufacture and import of the medicine for commercial reasons.
Since then, SUS reference hospitals, such as the National Cancer Institute (Inca), have faced zero stocks, forcing patients to buy the medicine directly with their own resources or to depend on occasional loans between health units.
