History in the making

FDA’s approval of Merck & Co.’s pembrolizumab marks a watershed moment, heralding the possible era of 'tumor-agnostic' drug approvals

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I’ve been covering the medical and life-sciences realms for a long while now—almost my entire career. As a result, I’m proficient in spelling a lot of words the average person would never have occasion to write down. I do a good job (or at least, I hope you agree I do) in picking out stories that are interesting or meaningful to people in pharma and biotech. But in the end, I’m not a scientist of any kind. I’m a journalist.
So, when one of the members of the DDNews  team with a scientific background (Randall C Willis or Peter T. Kissinger, to be exact) sends something to me and says “interesting oncology action here,” as Pete did with a recent Seeking Alpha article about FDA’s approval of Merck & Co.’s pembrolizumab—well, I tend to pay a special amount of attention.
Turns out Merck got approval for its agent not for a specific tumor type, but for a specific tumor biomarker: MSI-H (microsatellite instability-high) or MMRd (mismatch repair deficiency). After the phrase got heavily overused in the 1990s, I try to avoid it, but I will have to call this a “paradigm change” for sure. As long as the patients have failed other options and show evidence of the appropriate biomarker, they are eligible to use this drug, regardless of the tumor type or the age of the patient.
As Dr. Zack Hartman at Seeking Alpha put it, “[This] approval could very well be a watershed moment, both for [Merck] and for oncology on the whole. If a ‘universal’ biomarker can be identified for a given agent, then we now know that the doors open to get approved in any tumor type. It means huge things for molecular testing. It means huge things for finally achieving personalized cancer care.”
This doesn’t mean that Merck’s drug can work for every tumor, as the biomarker still needs to be there and it’s not a widespread marker, but this is in many ways a “tumor-agnostic” approach, and it will be interesting to see how often and how readily the FDA does this with other upcoming oncology therapeutics. But it’s safe to say that while I might have missed the significance of this approval news if Pete hadn’t alerted me, other companies in the cancer-treatment space won’t have missed it, and Merck won’t likely hold this unique distinction for long.
Of course, as with any issue of this magazine, this isn’t the only oncology news you can expect to see between the covers this month. But this June issue gives you more than the usual amount by far.
There’s a special report on cancer metabolomics by Randy Willis that gives a very nice overview of where metabolism research is going generally in terms of technology and what this means for oncology research in particular, and some post-show coverage of the recent American Association for Cancer Research annual meeting starting on page 29. Our Late-breaking News section in the back of the magazine is entirely oncology-related this month, and on page 39 and 40 we share a few gems from our Cancer Research News website, which you can find at www.ddn-cancer.com. (To view the full PDF of the issue so you can find those page numbers, if you don't have the physical issue, click here)
Not to mention oncology-oriented stories scattered among the many other therapeutic areas in our various news sections. Dig in, learn more—and tumors beware!

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