Saturday September 21, 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)

Next Story

Quitting Smoking Reduces Risk of Bladder Cancer in Women: Study

Our study emphasizes the importance of primary prevention (by not beginning to smoke) and secondary prevention (through smoking cessation) in the prevention of bladder cancer among postmenopausal women

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Representational Image. Woman smoking. Image source: www.dailyjoint.com

Quitting smoking can reduce the risk of bladder cancer in older women, says a study, adding that the most significant reduction in risk occurred in the first 10 years after quitting.

The researchers used various statistical models to analyse the association between the years since quitting smoking and the risk of bladder cancer.

For the study, the researchers included data from 143,279 women, all of whom had supplied information on whether they had ever smoked cigarettes, how much they had smoked and whether they were current smokers.

The study found that 52.7 per cent of the women were categorised as “never smokers,” 40.2 per cent as former smokers, and 7.1 per cent as current smokers.

marijuana, cancer
Quitting smoking cuts bladder cancer risk in women. Pixabay

“Although bladder cancer is a fairly rare cancer type, representing an estimated 4.6 per cent of new cancer cases in 2019, it is the most common malignancy of the urinary system, with high recurrence rate and significant mortality,” said Yueyao Li, Ph.D candidate from the School of Public Health, Indiana University in Bloomington, US.

“Smoking is a well-established risk factor for bladder cancer, but findings on the relationship between duration of smoking cessation and the reduction in bladder cancer risk are inconsistent,” Li added.

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Published in the journal Cancer Prevention Research, the study found that the steepest reduction in risk occurred in the first 10 years after quitting smoking, with a 25 per cent drop. The risk continued to decrease after 10 years of quitting.

“Our study emphasizes the importance of primary prevention (by not beginning to smoke) and secondary prevention (through smoking cessation) in the prevention of bladder cancer among postmenopausal women,” said Li. (IANS)