Johnson & Johnson's drug Balversa won U.S. approval as the first targeted t...
FILE PHOTO: A Johnson & Johnson building is shown in Irvine, California, U.S., January 24, 2017. REUTERS/Mike Blake
The list price of the drug, known chemically as erdafitinib, will range between $10,080 to $22,680 for a 28-day supply, depending of the dose, J&J said. 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.
“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.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Zogenix plummets 30% after FDA refuses to review its seizure treatmentAs part of a preliminary review, FDA determined that the application was not sufficient enough for a substantive review.
Read more »
FDA warns companies to stop making ‘unsubstantiated’ claims about CBD curing cancer and Alzheimer’sWarning letters from the FTC and FDA come ahead of a public hearing on the increasingly popular additive.
Read more »
The most common active ingredient in hand sanitizer is still under FDA investigationAfter reviewing the safety and effectiveness of hand sanitizers, the US Food and Drug Administration has ruled that dozens of active ingredients can't be used in the antiseptic rubs, but the agency still wants answers about the most common active ingredient.
Read more »
FDA approves new osteoporosis drugThe US Food and Drug Administration on Tuesday approved the drug Evenity, or romosozumab, to treat osteoporosis in postmenopausal women at high risk of bone fractures.
Read more »
FDA's stiff warning to health apps highlights opportunity for providersFDA warned mobile health app and devices developers that claim to diagnose traumatic brain injuries, suggesting mHealth market is riddled with flaws.
Read more »
FDA threatens to fine Walmart, Kroger and convenience store chains for selling tobacco to minorsThe agency cited high rates of violations in nearly identical letters sent to retailers last week.
Read more »
Analysis | The Health 202: Drug maker accuses FDA of hampering its medication for opioid treatmentThe Health 202: Drug maker accuses FDA of hampering its medication for opioid treatment
Read more »
Zogenix stock drops 25% after FDA rejects filingZogenix Inc. shares dropped in the extended session Monday after announcing that the Food and Drug Administration did not accept a marketing application for...
Read more »
Five Years After Cancer Warnings, Some Hospitals Still Use Hysterectomy ToolPiedmont Atlanta Hospital lets gynecologists use laparoscopic power morcellators. In the same city, Emory Healthcare stopped using the devices. The contrast underscores a simmering debate.
Read more »
Your refrigerator temperature could be ruining your foodAccording to the CDC and FDA, your refrigerator should never be higher than 40ºF., via reviewed
Read more »