A new drug application has been filed for the development of a novel cancer treatment.
The FDA is proposing a new drug for colorectal cancer to treat a gene mutation that makes the cell unable to divide, according to an announcement.
The drug, called Norlens, would target the mutation known as a G2A2 gene mutation, which makes cells unable to multiply or divide, the FDA said in a statement.
The agency said the drug is in the early stages of development and that its approval could come as early as June.
The development would be the first time that a drug is approved for use against a specific mutation, the agency said.
The mutation affects 1.5 million people in the U.S., according to the FDA.
There are no known side effects from the drug.
The gene mutation is not the only genetic risk that people carry.
The mutation also causes a wide range of other diseases.
For example, people with the mutation have a 50 percent higher risk of cancer and a 40 percent higher chance of stroke, the National Institutes of Health said.
A cancer gene mutation can lead to a range of medical conditions including multiple myeloma, lymphoma, and other types of cancer.
The risk is also higher for people who are older, have a history of having certain cancers, or are older and in certain other diseases, the NIH said.
Other genes affected by the mutation include those for the enzymes that cause proteins to break down, making them harder to use for cancer research, the CDC said.
Patients can receive the drug through a generic version that has the same gene sequence, but it could cost more.
The first phase of the drug would be administered to people who already have the mutation.
It would then be expanded to people with other mutations.
The company, Ion Therapeutics, will develop the drug based on a prototype for two other genes.
The companies hopes to make the drug available for the public in the next three to five years, Ion said in its announcement.
The FDA said the company had already raised $25 million to make that happen.
In a statement, Ion called the drug an important first step toward the development and approval of a new treatment for cancer.
“We are excited to be working with our industry partners and leading cancer research to develop this exciting and important product, and to bring Norlins groundbreaking technology to the forefront of the cancer treatment landscape,” the statement said.