According to the same source, the National Authority for Medicines and Health Products (Infarmed) has already asked the laboratory that owns the drug to submit an early access plan.

The appeal for the National Health Service (SNS) to make the drug pembrolizumab available for this type of breast cancer gave rise to two petitions, both addressed to the National Authority for Medicines and Health Products (Infarmed), which gathered more than 50,000 signatures.

Asked today by the Lusa agency about the availability of this medicine to patients with metastatic triple-negative breast cancer, Infarmed said that “in the light of new data” arising from the pharmacotherapeutic evaluation report of the medicine, it was found that “it is likely to be authorised".

Regarding the use of pembrolizumab in this type of cancer in the context of advanced/metastatic disease, Infarmed advances in a written response sent to Lusa that following the “reconsideration of this request for an Early Access Plan (PAP) in the light of new data, resulting from the pharmacotherapeutic evaluation report of the drug (in this indication), which was concluded recently, it is concluded that it is likely to be authorised”.

Speaking to the Lusa agency, a source from Infarmed said that this process had already started last year, had “advances and setbacks”, and that now, in the light of new data, it has been verified that this treatment constitutes “a therapeutic asset”.

According to the same source, Infarmed has already asked the laboratory that owns the drug to submit the early access plan so that doctors can order the drug through exceptional authorisations.

Obtaining marketing authorisation for innovative medicinal products is normally granted by the European Commission, after obtaining an opinion from the European Medicines Agency.

After this phase, and in order to be used and financed by the SNS, medicines must demonstrate a therapeutic and economic advantage compared to national clinical practice, in order to guarantee access for all citizens to both innovative therapies and other care that need in the context of the SNS.

This assessment is carried out by the Commission for the Assessment of Health Technologies (CATS of Infarmed, which includes clinical experts (doctors) with recognised knowledge and experience in the treatment of patients in SNS hospitals.