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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