It Is Nice To See That There Are Still Some Real “Priorities” — In Next Gen Immuno-Oncology: Good FDA News, At Merck [Power Alley]…

We used to write quite a bit about “priority review vouchers” at FDA (and, more precisely, the secondary market — in selling and buying them — we weren’t… fans of that wrinkle). [But all that has fallen off the radar screen, in large measure, since Tangerine 2.0 has very few actual “pro-life-science” priorities — and his minion, Kennedy, Jr. seems hell-bent on keeping most new drugs from being approved.] Now, to keep the bidding straight, the company’s Belzutifan is already approved in the EU, for a more limited set of indications — while US patients do already get it under FDA investigational exemptions, at present.

And yet, into the teeth of all of that, a very promising drug candidate has received a new FDA priority review designation (and we know Merck will never sell that!) for treatment of earlier-stage clear cell renal cell carcinoma. That’s great news — as it could mean that Rahway’s oral HIF-2α inhibitor might be on market by June 20, 2026, or so.

Here’s the latest, from FirstWordPharma.com:

…A preliminary interim analysis from a late-stage study of Merck & Co.’s Welireg (belzutifan) in earlier-stage clear cell renal cell carcinoma (RCC) showed that the oral HIF-2α inhibitor significantly boosting disease-free survival (DFS) when combined with the PD-1 inhibitor Keytruda (pembrolizumab) as adjuvant therapy following nephrectomy. The latest readout — building on findings highlighted last October — prompted a priority review by the FDA, with a target action date of June 19.

The LITESPARK-022 trial randomised 1841 patients to receive either Welireg plus Keytruda for approximately one year, or Keytruda plus placebo, with the primary endpoint being DFS.

Results presented Saturday at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) showed that Welireg plus Keytruda lowered the risk of disease recurrence or death by 28% compared with Keytruda plus placebo at a median follow-up of 28.4 months. While the estimated 24-month DFS rate was 80.7% for the combination arm versus 73.7% for the control arm, median DFS was not reached in either group. The trial’s key secondary endpoint of overall survival (OS) continues to be evaluated….

Now you know, as Iran is now firing missiles into… Turkey. Damn. Damn. Damn. Hegseth had zero sense of what he and Tangerine would unleash, here. And US troops have been (and will be) paying for it — with their very lives. Damn.

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