Keytruda (pembrolizumab) is a prescription medicine from Merck’s (MRK) immuno-oncology franchise used for the treatment of various tumors (see Part 4 of this series).
On September 5, 2017, the European Commission approved Keytruda for the treatment of advanced or metastatic Urothelial carcinoma, a type of bladder cancer in two cases:
- patients who have been previously treated with platinum-based chemotherapy
- patients who are not eligible for cisplatin-containing chemotherapy
The approval was based on the data from Keynote-045, a phase-3 trial that evaluated Keytruda in patients who were previously treated with platinum-based chemotherapy, compared with investigator-choice chemotherapy with paclitaxel, docetaxel, or vinflunine. The results show a superior overall survival in Keytruda.
The approval from the European Commission for both these indications allows Merck’s Sharp & Dohme to market Keytruda in 28 European Union Member states, Lichtenstein, Iceland, and Norway.
On August 30, 2017, Merck announced that it would present data from 12 different studies evaluating Keytruda as a monotherapy, as well as in combination with other drugs, at the ESMO (European Society for Medical Oncology) Congress, to be organized between September 8, 2017, to September 12, 2017, in Madrid, Spain.
The company will include data from its Keynote-040 study evaluating the use of Keytruda in advanced squamous cell carcinoma of the head and neck. It will also include additional results from a Keynote-021 cohort G study evaluating the use of Keytruda in combination with pemetrexed and carboplatin as a first-line treatment for advanced non-squamous non-small cell lung cancer.
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