FDA Approves Lytgobi for Advanced Cholangiocarcinoma

The Food and Drug Administration approved Lytgobi for patients with previously treated advanced cholangiocarcinoma with FGFR2 gene rearrangements.

The Food and Drug Administration (FDA) approved Lytgobi (TAS-120; futibatinib) for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma — a type of cancer that originates in the bile ducts — that has FGFR2 gene rearrangements, including gene fusions.

The approval is based on findings from the TAS-120-101 clinical trial, which showed 42% of patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring a FGFR2 gene fusion or other rearrangement have their disease shrink as a result of treatment (a statistic called overall response rate).

The average duration of response was 9.7 months in the patients who saw a response.

Today’s approval will add to the list of targeted drugs available to treat cholangiocarcinoma. However, one expert explained that the majority of patients with cholangiocarcinoma will still receive upfront standard of care, namely Gemzar (gemcitabine) and cisplatin.

Lytgobi works by binding to and blocking the FGFR pathway, which is involved in the survival and proliferation of cancer cells. To be eligible for the trial, patients should not have received a prior FGFR inhibitor. They were also required to have no or minimal impact on their daily living as a result of their disease; had previously received Gemzar and platinum-based chemotherapy; and have had disease progression on at least one systemic (throughout the body) treatment.

Prior research on Lytgobi showed that patients with advanced cancer who were administered the drug tended to maintain their physical, cognitive, emotional and overall health.

However, Lytgobi did have side effects. Most commonly, they were: nail-related side effects; musculoskeletal pain; constipation; diarrhea; fatigue; dry mouth; hair loss; mouth sores or inflammation; abdominal pain; dry skin; joint pain; changes in taste; dry eye; nausea; decreased appetite; urinary tract infection; hand-foot syndrome, characterized by redness, blistering or swelling in the palms and feet; and vomiting.

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