Tamping Down Some Of The MSM Hype — This Is Very Encouraging Immuno-Oncology Regulatory News…

To be sure, Kenilworth has scored more than a PR victory here. This is a real regulatory policy advancement coup. Yesterday, in the US, Keytruda® was approved by FDA for all solid tumors (regardless of location, or origin) expressing either of a certain set of proteins, at high levels.

While more than a few writers (and many a smaller bio-science companies’ hopeful PR departments) are now spinning this as some form of the second coming — it is not quite all of that. I suspect FDA will not just start granting new companies FDA clearance based on one study that crosses two locations, for tumor origin. Merck is nearly unique (save perhaps BMS) in that it can point to six to ten study outcomes, across many tumor sites, in which protein expression was a clear predictor of enhanced survival, while on pembrolizumab. Here’s the bit, from Reuters — minus the subsequent hype:

. . . .The approval marks a major step in so-called precision medicine, where genetic biomarkers may determine the course of therapy rather than the type of cancer. The hope is that advanced genetic information will one day be able to identify which patients are most likely to benefit from a specific treatment.

“Until now, the FDA has approved cancer treatments based on where in the body the cancer started – for example, lung or breast cancers,” said Richard Pazdur, head of oncology products for the FDA’s Center for Drug Evaluation and Research. . . .

The accelerated approval was for solid tumor cancers not eligible for surgery or that have spread in patients identified as having a biomarker called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). . . .

He said about 4 percent of advanced cancers, or 15,000 to 20,000 cases each year in the United States, carry the genetic traits addressed in the approval.

Tests for the specific genetic defects are widely available, costing between $300 and $600. . . .

Now you know — and the sunshine in the graphic is designed to counter the chilly gray rain I find myself walking in, on this cool Chicago morning. I hope it brightens all your gray days, out there, as well. Smile. . . .



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