BridgeBio Pharmaceuticals has recently announced that their drug, infigratinib, has received the Fast Track and Orphan Drug designations from the FDA. This drug is meant for the treatment of metastatic or unresectable advanced cholangiocarcinoma. If people have this type of cancer and have FGFR2 gene fusions or translocations, then they are eligible to take infigratinib. BridgeBio is excited to have received these designations, as they mean that they will be reviewed faster, receive tax credits for trials, and have seven years of market exclusivity. It also means that the drug may be widely available sooner, and it will be able to help more people.
About Cholangiocarcinoma
Cholangiocarcinoma is bile duct cancer. It is a rare cancer that typically affects people who are over age 50, but it has the potential to develop at any age. It is classified into three different types, depending on where the cancer occurs in the bile ducts. Intraheptic takes place in the part of the duct where the liver is. Due to its proximity to the liver, it is sometimes classified as a type of liver cancer. Hilar occurs right outside of the liver, and distal happens in the duct closest to the small intestine.
If one has cholangiocarcinoma they may experience jaundice, intense itching, fatigue, abdominal pain, white-colored stool, and unintentional weight loss. These symptoms occur due to a mutation in the DNA that cause cells to rapidly grow and multiply, forming a tumor.
While the cause of cholangiocarcinoma is unknown, there are known risk factors that increase the likelihood of developing it. Older age, smoking, primary sclerosing cholangitis, chronic liver disease, a liver parasite, and bile duct problems that were present at birth are all risk factors.
While there are certain things that can increase the chance of having this cancer, there are others that can lower the risk. These include avoiding smoking and lowering the risk of liver disease. The latter means drinking a healthy amount of alcohol, eating a healthy diet, exercising, and using aspirin.
Multiple tests may be performed to diagnose cholangiocarcinoma. A doctor may conduct a liver function test, a tumor marker test, an endoscopic retrograde cholangiopancreatography (ERCP), imaging tests, or a biopsy. Additional tests may be necessary to evaluate the extent and stage of the cancer.
After a diagnosis is confirmed treatments include surgery, a liver transplant, chemotherapy, radiation, photodynamic therapy, and biliary drainage. Symptomatic care is also important for the treatment of this cancer.
About BridgeBio’s Study
The study of infigratinib is in its third phase, and it is meant to evaluate the oral drug as a first-line treatment. Patient enrollment and dosing is currently happening, with a goal of enrolling 384 participants. Patients will receive either infigratinib or the standard chemotherapy treatment in a 2:1 ratio. If participants who are treated with chemotherapy do not respond to it, they will have the option to switch over to infigratinib.
BridgeBio is very excited about this upcoming phase and the designations assigned by the FDA. As there is an unmet medical need for treatments of cholangiocarcinoma, they hope that their new drug will positively impact the lives of those with this cancer.
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