Cholangiocarcinoma Treatment: FDA Grants Orphan Drug Designation for Yeliva Drug

The United States Food and Drug Administration granted orphan drug designation to Yeliva drug for Cholangiocarcinoma treatment.

Highlights

Cholangiocarcinoma or the cancer of the bile ducts is the second most common liver cancer in the world.
The Food and Drug Administration (FDA) grants Orphan drug designation for Yeliva drug to treat Cholangiocarcinoma.

The United States Food and Drug Administration has recently granted Orphan Drug Designation to Yeliva drug from the RedHill biopharmaceuticals for the treatment of Cholangiocarcinoma.

The Phase IIa clinical trials study with Yeliva drug for patients with advanced cholangiocarcinoma is expected to be initiated by the end of 2017.

Bile Duct Cancer | Cholangiocarcinoma - Causes, Risk Factors, Symptoms, Diagnosis, Stages, Treatment, Support Groups
Bile duct cancer occurs either within the liver or the point where the bile ducts emerge from the liver or outside the liver.

‘Orphan drug designation has been granted by the FDA for Yeliva drug to treat Cholangiocarcinoma.’

Cholangiocarcinoma or bile duct cancer is a lethal malignancy condition with a very fewer treatment options. In the United States, around 8000 people are diagnosed with bile duct cancers. Treatments are not effective and cholangiocarcinoma has a poor prognosis.

The five-year survival rate of intrahepatic and extrahepatic cholangiocarcinoma patients may range between 2% to 30%

Clinical Trials
The research study was conducted on three patients with cholangiocarcinoma in Phase I study. These patients had prior therapy. Of these patients, one of them had sustained partial response and the other two patients had prolonged stable disease.

Drugs for Bile Duct Cancer
View list of generic and brand names of drugs used for treatment of Bile Duct Cancer(Cholangiocarcinoma ). Find more information including dose, side effects of the Bile Duct Cancer(Cholangiocarcinoma ) medicine.

The study will evaluate Yeliva drug as a single agent in cholangiocarcinoma patients which will determine single response rate for treatment.

Several phase I and phase II studies with Yeliva drug are ongoing for the treatment of advanced hepatocellular carcinoma.

Liver Cancer
Liver is the largest organ inside the human body. It performs 500 different functions and processes 720 liters of blood per day. The important functions of the liver, the development of liver cancer and it’s symptoms are presented in this interactive.

Yeliva Drug
Yeliva drug is an orally administered sphingosine kinase-2 (SK2) inhibitor. The drug mainly acts by inhibiting the SK2 enzyme and blocks the synthesis of sphingosine 1 -phosphate (S1P). This lipid molecule may promote cancer growth and pathological inflammation.

The drug is well-tolerated and can be safely administered to patients at doses which provide circulating levels.

Liver Cancer Treatment
Liver Cancer is the uncontrolled growth of cells in the liver. The present section provides a graphic description of the various forms of liver cancer treatment in addition to the latest techniques such as Chemoembolisation and Radio frequency Ablation.

Orphan Drug Designation
Orphan drug designation is assigned for drugs which are used for the treatment of rare disease or condition upon the request of the sponsor.

Benefits of Orphan Drug Designation

Includes Tax Credit for Qualified Clinical Testing
Waiver for Prescription drug user fee (PDUFA Fee)
Seven-year marketing exclusivity period for Cholangiocarcinoma treatment if the drug is approved.

Cholangiocarcinoma

It is a type of liver cancer which arises within the biliary system.
Cholangiocarcinoma is often referred to as the cancer of the bile ducts.
There is no early diagnosis for cholangiocarcinoma.
Cholangiocarcinoma is more common in people above the age of 60 years.
Symptoms of cholangiocarcinoma may include abdominal discomfort, loss of appetite, tiredness and weight loss.

References

Cholangiocarcinoma: The facts - ( http://worldcholangiocarcinomaday.org/item-2/)

Source-Medindia