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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.


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.


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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Rihanna was summoned from her seat to accept the honour, with the Prime Minister.

Singer Rihanna was honoured by Prime Minister Mia Mottley at an event which marked Barbados's new status as a republic, which was attended by Prince Charles. Addressing the pop star by her real name, the PM said: "Robyn Rihanna Fenty tomorrow morning shall have conferred upon her the order of national hero of Barbados."

Rihanna was then summoned from her seat to accept the honor, with the Prime Minister managing to rouse a laugh from the singer when she referenced her 2012 hit 'Diamonds', reports femalefirst.co.uk. She added: "On behalf of a grateful nation, but an even prouder people, we therefore present to you, the designee, for the national hero of Barbados." "And to accept on behalf of a grateful nation - you can come my dear - ambassador Robyn Rihanna Fenty, may you continue to shine like a diamond and bring honor to your nation." Rihanna, who was born in the St Michael parish of Barbados, found fame in 2005 after being spotted by a record producer and has since gone on to become one of the most successful female artists of all time with sales of over 250 million and recently reached billionaire status through her Fenty beauty brand.

The Prime Minister continued in her speech: "Commanding the imagination of the world through the pursuit of excellence, her creativity, her discipline, and above all else, her extraordinary commitment to the land of her birth. "Having satisfied that, Ambassador Robyn Rihanna Fenty has given service to Barbados which has been exemplified by visionary and pioneering leadership, extraordinary achievement and the attaining of the highest excellence to the Government of Barbados." It comes after a historic move for Barbados, which has become a republic after almost 400 years and welcomes its first president, Sandra Mason, after removing Queen Elizabeth as head of state. (IANS/ MBI)


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