In a first time ever, the U.S. Food and Drug Administration granted its accelerated approval to a cancer drug which targets a biomarker and not a particular body part. This means that it will deal with the cancer’s genetics, and less with its position and place of appearance in the body.
The FDA issued an announcement on the matter by posting a release on its Newsroom. In it, the administration revealed that the cancer drug in question is Keytruda (pembrolizumab). This can start being prescribed to patients with solid tumors that also express mismatched repair genes.
Targeting the Biomarker and Not the Location Is a Whole New Approach
This is the first such drug approved for utilization in treating cancer. Many are already pointing out its landmark status and possible turning point brought by this decision. They are also underlining the scientific advances that made it a possibility.
The FDA also drew attention to this element and the drug’s historic approval in its statement.
“This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.”
Following the approval of this new cancer drug, doctors will be taking a closer look at the defining features of particular solid tumors. They will be looking to determine if it is an MSI-H or dMMR. More exactly, if they are mismatch repair deficient or microsatellite instability-high. Both of these are abnormalities which affect the DNA repair process inside the cell.
The FDA states that gastrointestinal, colorectal, and endometrial cancers present the highest frequency of such mutations. Both dMMR and MSI-H also appear, although more rarely, in cancers located in other places such as the prostate, bladder, thyroid gland, and breast, among others.
Keytruda works by finding a specific biomarker, in this case, the PD-/PD-L1 cellular pathway, and blocking it. This way, it tries to help the body fight back against the cancer cells.
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