Gilenya, known generically as fingolimod, is a medication primarily used to treat relapsing forms of multiple sclerosis (MS). One important concern for patients and healthcare providers is whether Gilenya increases the risk of cancer, particularly skin cancers and lymphomas.
Gilenya has been associated with an **increased risk of certain types of skin cancers**, including basal cell carcinoma, melanoma, and squamous cell carcinoma. Clinical trials have shown that patients taking Gilenya had a higher incidence of basal cell carcinoma compared to those on placebo. For example, in two-year placebo-controlled studies, about 2% of patients on Gilenya developed basal cell carcinoma, compared to 1% in the placebo group. Cases of melanoma and other skin cancers like Merkel cell carcinoma have also been reported after the drug was marketed. Because of this, patients on Gilenya are advised to have regular skin examinations before starting treatment and periodically afterward. They should also monitor for any suspicious skin changes and limit exposure to ultraviolet light by using sunscreen and protective clothing. Combining Gilenya with UV-based phototherapy is generally not recommended due to the increased risk of skin damage and cancer.
Beyond skin cancers, there have been reports of **lymphomas** in patients treated with Gilenya. These include both T-cell and B-cell lymphomas, as well as central nervous system lymphomas. The rate of non-Hodgkin lymphoma in patients taking Gilenya appears to be higher than expected based on general population statistics adjusted for age, gender, and region. Cutaneous T-cell lymphoma, such as mycosis fungoides, has also been observed in some cases. This suggests that Gilenya’s immune-modulating effects might contribute to an increased risk of certain lymphoid cancers.
The underlying reasons why Gilenya might increase cancer risk are not fully understood but are thought to relate to its mechanism of action. Gilenya works by modulating sphingosine-1-phosphate (S1P) receptors, which play a role in immune cell trafficking. By trapping lymphocytes in lymph nodes, Gilenya reduces their circulation and activity in the central nervous system, which helps control MS inflammation. However, this immune suppression can also impair the body’s ability to detect and destroy emerging cancer cells, potentially allowing tumors to develop or progress.
Some research suggests that fingolimod might act as a tumor-promoting agent by affecting processes such as cell growth, migration, and angiogenesis (the formation of new blood vessels that tumors need to grow). It may also alter immune surveillance and keratinocyte behavior in the skin, increasing susceptibility to skin cancers. Despite these concerns, not all studies have found a direct causal link, and some cohorts treated with fingolimod did not develop melanoma or non-melanoma skin cancers during follow-up. This indicates that while the risk is elevated, it may not be very high for every patient and could depend on individual risk factors.
Patients taking Gilenya should be vigilant about skin health, reporting any new or changing moles, lesions that bleed or leak fluid, or other suspicious skin changes to their healthcare provider promptly. Regular dermatologic check-ups are recommended, especially for those with a personal or family history of skin cancer or significant sun exposure.
In addition to cancer risks, Gilenya has other notable side effects, including liver injury, which requires monitoring of liver enzymes during treatment. While these are not directly related to cancer risk, they highlight the importance of careful medical supervision when using this medication.
In summary, Gilenya does increase the risk of certain cancers, particularly skin cancers and lymphomas, due to its immune-modulating effects. This risk necessitates regular monitoring and preventive measures but must be balanced against the benefits of controlling multiple sclerosis disease activity. Patients and doctors should work together to manage these risks through vigilant skin examinations, limiting UV exposure, and promptly addressing any suspicious symptoms.
