EMA to review programmed-death cell drug for cancer treatment
- EMA is reviewing pembrolizumab for the treatment of advanced melanoma.
- There will be multiple regulatory filings in different countries during the second half of the year.
- Prembolizumab is currently under review by FDA and could be approved as early as October.
Merck is rapidly submitting applications to various regulatory agencies for pembrolizumab, which analysts expect may have peak sales of approximately $500 million. If pembrolizumab is approved, it will be the first PD-1 cancer therapy in Europe. PD-1 stands for programmed cell death 1 protein—a form of immunotherapy that leads the body to target and kill cancer cells.
- pharmafile.com PD-1 cancer race heats up as Merck takes lead