Merck Scores New EU Approval For Keytruda® — In Certain Bladder Cancers

I’ll use a throwback graphic, from a time when the candidate was known by its chemical name — and not yet branded. To be certain, this is decidedly good news.

While both Kenilworth and BMS expect important new US FDA indication approvals in the last few days of September of this year (for Opdivo® and Keytruda®), the entrance of additional immuno-oncology agents (from two other competitors) has dampened the significance of any one approval out of FDA. Each of BMS and Merck will make perhaps $5.8 billion in revenue next year on their immuno offerings alone. Here’s a bit of the latest EU nod — for Merck:

. . . .[T]he European Commission has approved KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Specifically, KEYTRUDA is approved for use as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy.

The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial.

The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase 2 data from the KEYNOTE-052 trial, which demonstrated an overall response rate (ORR) of 29 percent (95% CI, 25-34).

The approval allows for the marketing of KEYTRUDA in these two new indications in all 28 EU member states plus Iceland, Lichtenstein and Norway at a dose of 200 mg every three weeks until disease progression or unacceptable toxicity. . . .

Now you know — as a shortened office week begins. Onward, after a wondrously languid and long holiday weekend. . . . now a quite busy day ahead, as it is high time to get after Trump (on his unlawful DACA detainers), over at the federal courthouse on Dearborn.



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