Key facts
- FDA granted orphan drug designation to Merck's pembrolizumab.
- The designation is for the treatment of neuroendocrine prostate cancer (NEPC).
- Orphan drug status aims to accelerate development and availability of new therapies for rare diseases.
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Merck's pembrolizumab for the treatment of neuroendocrine prostate cancer (NEPC). This designation is a significant step in the drug development process, as it is intended to provide incentives to encourage the development of new therapies for rare diseases. NEPC is a rare and aggressive form of prostate cancer, and the orphan drug status is expected to accelerate the development and availability of pembrolizumab as a potential new treatment option for patients diagnosed with this condition.