Question 39003 — pharmacy and medications

Summary

To date, after the failure of standard chemotherapy protocols, there are few therapeutic options for this cancer. These cancers are characterized by the absence of hormonal receptors (progesterone and estrogen) and the HER2 protein. It is these “markers” that allow treatment therapies to “attack” cancer cells. The absence of these markers makes any treatment more difficult to treat. This type of cancer represents 15% of breast cancers, or 9,000 patients. TRODELVY is one of the first treatments to treat this type of cancer and is the first drug to demonstrate an improvement in the survival time of patients with this type of cancer. This drug was developed by a small American company, IMMUNOMEDICS, bought by GILEAD at the end of 2020 whose current production capacities are largely insufficient in relation to the needs of patients. Indeed, the production of this type of drug (conjugated antibody) is notoriously complex and long, around 1 year. There is therefore an incompressible amount of time to increase the number of drugs produced. At the end of 2020, its manufacturer filed an application for European marketing authorization (AMM) in March 2021 and launched production capacities to supply the market European. A first commitment was made by Gilead in January 2021 to provide access to 64 patients via the ATU mechanism. France is, today, the only country in Europe where Gilead distributes Trodelvy. From June 1, GILEAD, more than 78 patients will be able to benefit from this treatment. The Gilead group is committed to providing all sufficient quantities for access during the EU Marketing Authorization, expected in December 2021, i.e. in 7 months. He It is not a financial question but a question of production capacity. France is the European country to receive the most doses even if this unfortunately does not meet all the needs. The patient groups were received several times by the Ministry of Solidarity and Health and regular exchanges took place.

Machine translation from French. The official text remains authoritative.

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