According to an official source, the use of the drug pembrolizumab in patients reporting metastatic triple-negative breast cancer will be approved by Infarmed.
According to the same source, the National Medicines and Health Products Administration (Infarmed) has already asked the laboratory that owns the drug to submit an early access plan.
A call to the National Health Service (SNS) to make the drug pembrolizumab available for this type of breast cancer has resulted in two petitions, both to the National Medicines and Health Products Administration (Infarmed), which have garnered more than 50,000 signatures.
Asked by Lusa on Tuesday about the drug’s availability for patients with metastatic triple-negative breast cancer, Infarmed said “in light of the new data” obtained from the drug’s pharmacotherapeutic evaluation report, it was found that “these are subject to authorization.”
Regarding the use of pembrolizumab in this type of cancer in the context of advanced/metastatic disease, Infarmed, in a written response to Lusa, notes that following “a review of this early access plan (PAP) request in light of new data as a result of a pharmacotherapeutic evaluation report (for this indication), which was recently concluded, it is concluded that it is likely to be allowed.”
Speaking to Lusa, a source from Infarmed said the process had already started last year, had “successes and failures” and that the treatment has now been confirmed to be a “therapeutic asset” in light of new data. “. .
According to the same source, Infarmed has already asked the laboratory that owns the drug to submit an early access plan so that doctors can order the drug through exclusive authorizations.
Marketing authorization for innovative medicines is usually granted by the European Commission after receiving an opinion from the European Medicines Agency.
After this phase, in order to be used and funded by the SNS, medicines must demonstrate therapeutic and economic advantages over national clinical practice to ensure that all citizens have access to both innovative treatments and other care that is needed in the context of the SNS.
This assessment is conducted by the Medical Technology Assessment Panel (CATS of Infarmed), which is composed of clinical experts (physicians) with recognized knowledge and experience in treating patients in SNS hospitals.
Author: Portuguese
Source: CM Jornal
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