FDA Approves First Drug to Target Genetic Traits Of Cancer, Rather Than Body Location

The US Food & Drug Administration approved the first ever cancer drug that treats specific genetic traits of the disease, rather than the part of the body in which the cancerous tumor is located, as reported by the Los Angeles Times.

The move is being hailed as a breakthrough that could change the future of cancer care.

It means patients can get more specific care, and could provide a lifeline to those who are not eligible for mainline treatment since their disease has spread.

The FDA announcement marks an important milestone, close to two decades in the making. Increasingly, cancer will no longer be identified, categorized and treated by the organ it inhabits, or in which it first gained its foothold. In a shift that is already underway, cancers will be known by — and treated for — the common genetic mutations that nurture and sustain them.

The approved drug, Keytruda, made by Merck & Co, also generically known as pembrolizumab, is a form of immunotherapy which targets solid tumors with a biomarker called microsatellite instability-high [MSI-H] or mismatch repair deficient [dMMR].

These biomarkers are common in colorectal, endometrial and gastrointestinal cancers, but may also appear in cancers of the breast, prostate, bladder, pancreas, thyroid gland and others.

In clinical trial evidence cited by the FDA this week, pembrolizumab induced complete or partial tumor shrinkage in about 40% of patients with one of 15 end-stage malignancies. And for 78% of those patients, that response lasted six months or more.

All of those patients had cancers with the genetic mutation that pembrolizumab is designed to target.

Learn more in the FDA announcement, or by reading the report in the Los Angeles Times.

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