Merck’s KEYNOTE-A18 trial showed fairly impressive improvements in progression free survival in a wider range of first line but aggressive uterine cance patients, over simply using chemo-.

So it is highly likely that Merck will win the approval after priority review is complete, in January at FDA.
In any event, here’s the latest from the wires — but do go read it all:

…Merck’s KEYNOTE-A18 clinical trial showed that Keytruda plus chemoradiotherapy outperformed concurrent chemoradiotherapy. The endpoint offered a statistically significant improvement in progression-free survival.

The FDA circled January 20, 2024, as the target action date for a decision on the priority review. Keytruda is already approved in the U.S. in combination with chemotherapy and as a mono-therapy, for patients with cervical cancer whose tumors harbor the PD-L1 biomarker….

All good news, to be sure.

And now, if I might editorialize a bit — it is true that all these clinical trials are wildly expensive — and the ten year development arc for pembrolizumab likely cost close to $2 billion if fairly valued in today’s dollars. All that is true.

And Keytruda is one of dozens of projects like it at Merck — though in fairness it is the largest, in dollars spent.

Having said that, Keytruda is also the most successful therapy in Merck’s long history — now generating almost $22 billion a year in revenue, globally — and still growing at over 15 per cent a year, on the back of great study results in new arenas, like the above. It will enjoy exclusivity at the patent office until well after 2035 (with even moderately aggressive additional filings).

Contrast all that with the suit update we posted yesterday. There, the admittedly very good diabetes drug Januvia has been on market since 2006 — for 17 years, raking in a total of over $20 billion — having long ago made back about 20X what Merck spent in development. And yet, Merck continues to increase the selling price (at least to the federal government payors). Many elderly diabetics make a monthly choice: pay the winter heating bill (and/or wear down parkas indoors — in their apartments) or pay as much as $848 a month out of pocket, for their diabetes medication, Januvia.

It is not hyperbole to call that. . . a life or death choice. And that is simply… wrong. And Mr. Davis well-knows it. [This is not simply being unable to afford Mr. Musk’s latest screaming cyber-truck, or roadster. This is… life altering therapy — or the lack of it.]

He should voluntarily dismiss his silly strike suit — and sit down to negotiate sensible prices on these old (long paid for) drugs, with HHS and CMS. Out.

नमस्ते