Immuno-oncology, New Products

Pioneering Merck makes another breakthrough with PD-1 star Keytruda, grabbing first OK for a cancer biomarker

Merck continues to be the trendsetter to watch in immuno-oncology. On Tuesday the pharma giant nabbed a unique first in the field, grabbing an FDA approval to use Keytruda to fight cancer with a particular biomarker signature of its own.

Specifically, the agency has provided a green light to prescribe Keytruda to fight tumors with a biomarker called microsatellite instability-high or mismatch repair deficient.

Richard Padzur

Notably, cancer drug czar Richard Pazdur did the honors in recognizing the achievement in the FDA’s statement.

“This is an important first for the cancer community,” Richard Pazdur, acting director of the office of hematology and oncology products in the FDA’s CDER and director of the FDA’s Oncology Center of Excellence, said in a statement. “Until now, the FDA has approved cancer treatments based on where in the body the cancer started — for example, lung or breast cancers. We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”

The agency singled out tumors with abnormalities that play a role in DNA repair, highlighting colorectal, endometrial and gastrointestinal cancers, but also less commonly in cancers arising in the breast, prostate, bladder, thyroid gland and more.

In this case Merck was able to draw on data from five studies showing Keytruda’s ability to shrink a significant number of tumors.

Roger Perlmutter, Merck

Merck has been rolling up a string of impressive wins on the I/O front with its PD-1 checkpoint drug Keytruda. While Roger Perlmutter was lucky enough to have it in the pipeline when he arrived as R&D chief, he has pressed every advantage in expanding on its pioneering first approval.

A week ago the agency followed through with an OK for bladder cancer, its second in a few weeks. Just this morning the pharma giant scored an accelerated review for stomach cancer, a clear signal of future success. And Merck researchers will present data on 16 cancer types at ASCO in early June.

Recently the pharma giant leapfrogged Bristol-Myers Squibb on non-small cell lung cancer, winning an OK to use a combination of Keytruda and chemo as a frontline therapy. And there are hundreds of additional studies underway to test its efficacy in combo therapies.


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