Science / Medicine : FDA OKs Cell Therapy for Cancer

The first cancer therapy using genetically altered living cells was approved last week, and doctors at the National Institutes of Health said the first patient should start treatment within a few weeks. Steven A. Rosenberg said his team has been poised to start the revolutionary gene therapy in patients critically ill with advanced melanoma, a deadly skin cancer, and was only awaiting the final approval from the Food and Drug Administration.

The still-experimental therapy amplifies the body’s own cancer-fighting ability. It uses natural cancer-fighting cells, called tumor-infiltrating lymphocytes, that have been removed from a patient’s tumor and given extra genes that should enhance their ability to attack the tumor. The technique has been shown to be effective in laboratory animals.

Earlier this fall, other NIH researchers were granted permission to use gene therapy to treat children with an inborn defect in their immune systems that renders them highly susceptible to infections. Those studies are already under way.

Rosenberg’s team was given permission to treat up to 50 melanoma patients using the new gene technique.