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Danish Medicines Council Recommends Trodelvy for Metastatic Triple-Negative Breast Cancer

The Danish Medicines Council now recommends Trodelvy, a drug aimed at prolonging life, for women battling metastatic triple-negative breast cancer after previously rejecting it in 2022. This recommendation applies when surgery is no longer a viable option and other treatments have been exhausted.

The decision to recommend Trodelvy comes after updated data revealed that patients lived almost five months longer on Trodelvy compared to the standard treatment. This updated information, along with considerations for treatment equality, led to the reversal of the 2022 rejection, which was initially based on concerns about the drug’s uncertain effect and high cost.

Despite the positive development, the Danish Medicines Council acknowledges that Trodelvy remains expensive even after a recent price reduction from Gilead, the pharmaceutical company that produces the drug. Deputy Chairman of the Danish Medicines Council, Jannick Brennum, emphasized the need to balance the cost with the benefits for this patient group with a poor prognosis.

Metastatic triple-negative breast cancer is an aggressive and incurable disease affecting around 60 women in Denmark annually, often impacting younger individuals. The Danish Cancer Society highlights the significance of this recommendation for a particularly vulnerable group of patients.

While Trodelvy has been approved in other countries, including Sweden, Norway, and England, its inaccessibility in Denmark has led some patients to personally finance the treatment, incurring costs of up to one million kroner. The council has requested clinicians gather data on Trodelvy’s effects on survival rates and side effects in Danish patients to review the data and reconsider the recommendation in two years.

The Danish Medicines Council has cautioned that the study underpinning the recommendation may not fully represent Danish patients. Therefore, the true extent of the drug’s impact and side effects within the Danish population remains uncertain.