Recent regulatory approvals
In May 2017, the FDA approved Merck’s (MRK) Keytruda in a first-line setting for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
The FDA also approved Keytruda in a second-line setting for the treatment of individuals with metastatic urothelial carcinoma whose disease advanced during or after platinum-containing chemotherapy.
The above chart represents the efficacy of Keytruda in the KEYNOTE-045 and KEYNOTE-052 trials. To learn more about Keytruda’s long-term growth prospects, please read Keytruda Expected to Drive Merck’s Long-Term Revenue Growth.
The FDA approval of Keytruda as a first-line therapy was based on data from the KEYNOTE-052 trial. In the KEYNOTE-052 trial, Keytruda therapy on individuals with locally advanced/metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy demonstrated an objective response rate (or ORR) of 29%. Of these patients, 7% achieved a complete response rate and 22% achieved a partial response rate.
The FDA approval of Keytruda as a second-line therapy for treatment of individuals with locally advanced/metastatic urothelial carcinoma whose disease is in progress or disease progression continued post platinum-containing chemotherapy was based on results from the KEYNOTE-045 trial.
In the KEYNOTE-045 trial, the median overall survival (or OS) was 10.3 months for patients receiving Keytruda compared to 7.4 months for patients receiving chemotherapy. The superior clinically beneficial data of Keytruda in the clinical trial may boost the commercialization of the drug in the global market.
In July 2017, the European Medicines Agency’s (or EMA) Committee for Medicinal Products for Human Use (or CHMP) recommended a positive opinion for approval of Keytruda for the treatment of certain individuals with locally advanced or metastatic urothelial carcinoma.
Keytruda’s peers in the urothelial carcinoma drugs market include Bristol-Myers Squibb’s (BMY) Opdivo, Pfizer’s (PFE) Bavencio, AstraZeneca’s Imfinzi, and Roche’s (RHHBY) Tecentriq. Merck comprises ~5.5% of the Health Care Select Sector SPDR ETF (XLV).