Friday April 19, 2019

US Approves Drug ‘Balversa’ as First Targeted Therapy for Bladder Cancer

Bladder cancer is the sixth most common cancer in the United States, with the FGFR alterations present in about one in five patients

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bladder cancer
FILE - People walk along a corridor at the headquarters of Johnson & Johnson in New Brunswick, N.J. VOA

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration
announced Friday.

The list price of the drug, known chemically as erdafitinib, will range between $10,080 and $22,680 for a 28-day supply, depending on the dosage, J&J said.

Balversa is the first approved drug in a class known as FGFR inhibitors that targets growth factor receptors involved in cell growth and division.

bladder cancer
The list price of the drug, known chemically as erdafitinib, will range between $10,080 and $22,680 for a 28-day supply, depending on the dosage, J&J said. Pixabay

The drug is approved for use in patients whose cancer has progressed during or after chemotherapy and have specific genetic alterations known as FGFR3 or FGFR2. Patients will be selected for therapy with Balversa using an FDA-approved companion diagnostic device that will identify the genetic  mutations, the agency said.

Bladder cancer is the sixth most common cancer in the United States, with the FGFR alterations present in about one in five patients.

“We’re in an era of more personalized or precision medicine, and the ability to target cancer treatment to a patient’s specific genetic mutation or biomarker is becoming the standard,” Richard Pazdur, head of the FDA’s oncology products division, said in a statement.

 

bladder cancer
Balversa is the first approved drug in a class known as FGFR inhibitors that targets growth factor receptors involved in cell growth and division. Pixabay

J&J shares closed up 0.5 percent at $135.98. Shares of Incyte Corp., which is also developing a FGFR inhibitor, closed down 2 percent at $79.40.

ALSO READ: Prostrate Medicines Likely to Increase Risk of Type-2 Diabetes

The approval was based on a small 87-patient trial in which about a third of subjects experienced tumor shrinkage. The median duration before disease progression was 5.4 months.

Common side effects of the drug include high phosphate levels, mouth sores and fatigue. The drug may cause serious eye problems, including inflamed eyes, the FDA said. (VOA)

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Cheap anti-inflammatory Drug for Common Cold can Stop Spread of Cancer, say Japanese Researchers

The study conducted using animal model showed that injecting flufenamic acid a much cheaper cold drug into cancerous bladder cells can suppress the cells

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Representational image. Pixabay

Tokyo, October 18, 2016: A non-steroid, anti-inflammatory drug used for treating common cold has the potential to suppress the spread of bladder cancers as well as reduce their resistance to anti-cancer drugs in mice, Japanese researchers have found.

Bladder cancer — the seventh most common cancer in males worldwide — can be grouped into two types: non-muscle-invasive cancer, which has a five-year survival rate of 90 percent, and muscle-invasive cancer, which have poor prognoses.

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The latter are normally treated with such anti-cancer drugs as cisplatin, but tend to become chemo-resistant and, thus, spread to organs such as the lungs and liver, as well as bone, the study said.

The study conducted using animal model showed that injecting flufenamic acid — a much cheaper cold drug — into cancerous bladder cells can suppress the cells’ invasive activities and restore the effectiveness of anti-cancer drugs.

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“The study could pave the way for medical institutions to use flufenamic acid which has unexpectedly been proven to be effective at fighting cancers,” said Shinya Tanaka from Hokkaido University in Japan.

In the study, using rats the team created a xenograft bladder cancer model and discovered a three to 25-fold increase of the metabolic enzyme aldo-keto reductase 1C1 (AKR1C1).

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It was also identified for the first time that AKR1C1 enhances tumour-promoting activities and proved the enzyme blocks the effectiveness of cisplatin and other anti-cancer drugs, which can be inhibited by flufenamic acid, the researchers concluded in the paper published in the journal Scientific Reports. (IANS)