Erdafitinib for Cancer

This trial tests erdafitinib (Balversa), a treatment that might stop the growth of cancer cells with specific FGFR mutations. It targets patients with hard-to-treat cancers, such as certain solid tumors and lymphomas, that have spread or returned after other treatments. The trial aims to assess erdafitinib's effectiveness in these cases. Individuals with solid tumors featuring FGFR mutations who have not responded to other treatments might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

The trial requires that you stop taking certain medications before participating. You cannot be on other anti-cancer agents, investigational drugs, or certain medications that affect specific liver enzymes (CYP3A4 and CYP2C9). If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before joining the trial.

Research has shown that erdafitinib has been tested in patients with other types of cancer, such as bladder cancer. In these studies, hundreds of patients received the treatment, and results indicated that erdafitinib was generally well-tolerated. Most patients experienced side effects similar to those from other cancer treatments.

The most common side effects included changes in vision and dry mouth, while some patients experienced skin or nail issues. In rare cases, more serious side effects occurred.

Erdafitinib is unique because it targets specific genetic changes in cancer cells, called FGFR mutations, which are not addressed by most standard treatments like chemotherapy or immunotherapy. This targeted approach could potentially offer more effective results for those with these mutations. Additionally, erdafitinib is taken orally, which may provide a more convenient option compared to treatments that require hospital visits for infusions. Researchers are excited because this precision medicine can lead to better outcomes with potentially fewer side effects for patients with certain types of cancer.

Research shows that erdafitinib effectively treats cancers with FGFR mutations. Studies have found that erdafitinib can reduce the risk of death by 36% compared to chemotherapy for patients with certain cancers. Specifically, patients with metastatic urothelial carcinoma, a type of bladder cancer, lived longer on average—12.1 months compared to 7.8 months for those receiving chemotherapy. These results suggest that erdafitinib may slow the growth of cancer cells with FGFR mutations by blocking the enzymes they need to grow. While these findings are encouraging, they are based on studies of other cancers, so erdafitinib is still being tested for the specific conditions in this trial. Participants in this trial will receive erdafitinib as part of the study treatment.³⁶⁷⁸⁹