FDA Proposes New Rule for Targeted Treatment

As per new policy, targeted therapies seeking for FDA approval would also require approval for devices the therapy is performed with.

Pharma companies are developing more targeted treatments designed according to patients' genetic structure. Manufacturers of such treatments would have to get the device reviewed if the new proposed amendment come into effect.

Before giving approval to the medicine/therapy, FDA wants to test the device used in therapies. With that being said, therapy as well as device both would require clearance certificate from FDA.

Medicines that are targeted for specific patients only, are prescribed after a diagnostic test. Efficacy of the treatment is determined by studying genetic structure of a patient. After a thorough study physicians determine whether the therapy is fit to the patient or not. Such pre-tests are known as companion diagnostics (or targeted medicines).

One such drug in review is lung cancer drug Crizotinib of Pfizer. This drug targets genetic mutaion found in non-smokers with lung cancer of type NSCLC. Pre-test for the drug has been developed by Abbott.

However, new proposed rule has two exceptional situations where a medicine and its companion test can get approval without FDA. Medicine and its diagnostic test may get auto-approval either a disease is life threatening and no other treatment is found or benefits of the treatment is far more than the risk.