FDA Licenses Kidney Cancer Treatment
The first product specifically designed to treat kidney cancer was licensed by FDA last May.
The biologic, Proleukin (aldesleukin), is derived from genetically engineered bacteria that trigger a response from the body's immune system. It is one of the first successful cancer treatments using this method.
Proleuldn does not cure kidney cancer and has severe side effects in most patients. But it provides an alternative treatment for the disease, also called metastatic renal cell carcinoma, which kills about 10,000 people a year.
In seven clinical trials, Proleukin reduced the size of tumors in 15 percent of 255 patients. In 4 percent of patients, all evidence of their tumors disappeared for 23 months, and 11 percent reported a substantial reduction in the size of the tumor for nearly 19 months.
Four percent of patients died from side effects related to Proleukin. One life-threatening adverse reaction was capillary leak syndrome, the passing of plasma proteins and fluid outside the blood vessels.
Other serious side effects included irregular heartbeat, angina, heart attack, respiratory failure, gastrointestinal bleeding, kidney failure requiting dialysis, neurologic problems, and infections. …