The Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab Merck) for use in patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, the FDA has granted accelerated approval for use in patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. 

The regular approval was based on data from the multicenter, randomized, active-controlled KEYNOTE-045 trial that randomized patients to either Keytruda 200mg every 3 weeks (n=270) or investigator’s choice of chemotherapy (paclitaxel, docetaxel, or vinflunine) every 3 weeks (n=272). In the study, there were statistically significant improvements in overall survival (OS) and objective response rate (ORR) for patients in the Keytruda group vs. chemotherapy.

The median OS was 10.3 months vs. 7.4 months for the Keytruda and chemotherapy arms, respectively (hazard ratio [HR] 0.73, 95% CI: 0.59, 0.91; P=0.004). ORR was greater in the Keytruda arm vs. the chemotherapy arm (21% vs. 11%;P=0.002). There were no statistically significant difference in progression-free survival between the two arms.  

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The accelerated approval was based on data from the single-arm, open-label KEYNOTE-052 trial that evaluated Keytruda 200mg every 3 weeks in 370 patients. After a median follow-up of 7.8 months, the ORR was 28.6% (95% CI: 24, 34); the median response duration was not reached (range 1.4+, 17.8+ months). 

Keytruda, a programmed death receptor-1 (PD-1)-blocking antibody, was recently approved for use in combination with pemetrexed and carboplatin as first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. It is available as a 50mg lyophilized powder for IV infusion as well as a 25mg/mL strength solution for IV infusion. 

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