US FDA Approves Bladder Cancer Drug

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 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. 

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. 

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. 

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Voice of America

Peru Coca Eradication Work Turns Violent; at Least 2 Dead

Two farmers were killed in clashes in Peru that erupted Friday as authorities launched an operation to uproot coca plants — used to make cocaine — in a region near the border with Bolivia, a local mayor and the police said.

A third person was in critical condition and had been taken to a local hospital, said Roger Larico, the mayor of the district of San Gaban in the region of Puno.

The eradication team, 158 civilian workers and 72 police officers, had arrived to San Gaban before dawn to destroy illegal coca farms in the coming days, but were attacked by people wielding machetes and sticks as they sat up their camp, the Peruvian National Police said in a statement.

But Larico said witnesses told him that the police had fired live bullets recklessly.

“They were shooting right and left. That’s why we have this bloodshed,” Larico told Reuters by phone.

The deaths are under investigation, said Victor Rucoba, the head of the government’s eradication agency.

“It’s very likely that to protect their lives and the lives of unarmed civilians, police had to increase the use of force,” he added in comments broadcast on local TV channel Canal N.

Risky eradication

The unrest underscores the risks of forcibly eradicating illegal coca, a crop that tends to fetch a much higher price in Peru than alternatives such as coffee and cacao. It comes a day before U.S. Secretary of State Mike Pompeo visits the Andean country in a four-country tour of South America.

Peru has been one of the leading producer countries of cocaine for decades, despite efforts by consecutive governments to capture drug traffickers and shift farmers toward alternative crops from coca.

But in recent years, illegal coca farms in Peru have expanded.

The U.S. government said in November that Peru’s potential cocaine production had risen 20 percent to a 25-year high of 491 tons.

Police reinforcements were being sent to San Gaban to ensure the eradication team could work in the days ahead, said Rucoba, adding that coca cultivation had expanded “exponentially” in the area.

In a 2017 report, Peru’s anti-narcotics agency Devida said coca growers from the country’s most notorious drug-trafficking region, the VRAEM, had been migrating to Puno to start new farms. The coca produced in San Gaban is part of a supply chain that moves cocaine into Brazil through Bolivia, it added.

Peru plans to eradicate about 25,000 hectares (61,776 acres) of illegal coca crops per year through 2021, according to the country’s anti-narcotics plan.

Coca is also grown legally in Peru, where it is widely used as an infusion as well as in traditional indigenous rituals.

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Voice of America



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