Dive Brief:
- 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.
Dive Insight:
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.