Big Win for Johnson & Johnson With Bladder Cancer Drug Approved by FDA
Updated on April 19th, 2019
The pharmaceutical giant, Johnson & Johnson, has scored another win with its FDA approval on a bladder cancer drug. The drug, Balversa, belongs to the class FGFR inhibitors. These are known to target the receptors that allow cancer cells to grow and divide. With bladder cancer being the sixth most common in the United States, it’s bound to help a lot of people.
Not for All Bladder Cancer Patients
Balversa will not be offered to everyone who has bladder cancer. Its intended use is for a smaller target group. The idea is to help those who chemotherapy doesn’t work for and those who have specific gene alterations, specifically fibroblast growth factor receptors (FGFR) 2 and 3.
Approximately 1 in 5 patients has one of these mutations. Johnson & Johnson has a diagnostic device that identifies these specific mutations, and this device will be used to determine who qualifies for the drug.
How Balversa Gained FDA Approval
The approval of the medication came on the heels of a successful patient trial that involved 87 participants. Out of these 87, approximately one-third of the participants had their tumors shrink, attesting to the success of the drug.
Costly But Beneficial
According to Reuters, the list price of Balversa ranges between $10,000 and $23,000 depending on the dosage. The price is for a 28-day supply.
However, the benefit far outweighs the cost. Scientists and researchers have been discovering new ways to put biomarkers and genetic mutations to use by custom tailoring medications that single them out. It’s personalized medication at its finest.
Opens up the Doors to New Medications
This approval is a monumental one because it’s so unique in that it’s tailored to specific gene mutations. Much like CRISPR, Balversa is seeking out a single gene and attempting to cure the disease caused by the mutation.
Like other drugs, Balversa is not without its side effects. The FDA cautions that these can include inflamed eyes and other serious eye issues. In addition to this, patients experienced fatigue, mouth sores and higher than normal phosphate levels.
This approval is good news for patients who before now had limited options when it came to treating this aggressive form of cancer. Balversa is likely to be a real life-saver, literally. It’s expected to hit the market soon and should inspire more custom-tailored drugs that are promising to be the future of the prescription drug industry.