The FDA granted orphan drug status to Quratusugene ozeplasmid, a promising gene-based therapy for small cell lung cancer, to expedite its development.
The FDA has given a special status called “orphan drug designation” to a new medicine called Quratusugene ozeplasmid for treating small cell lung cancer. Getting this status means the company making the drug can get help from the FDA in developing it faster.
Quratusugene ozeplasmid works in a unique way to kill cancer cells. It carries a gene called LMB-100 into the cells. This gene makes a protein that is toxic to cancer cells but not normal cells. Early testing of the drug shows promising results against small cell lung cancer tumors. The company that makes Quratusugene ozeplasmid hopes the orphan drug status will help complete later stage clinical trials quickly.
The goal is to develop a new targeted therapy option for patients with small cell lung cancer, which currently has limited treatment choices. More research is still needed to confirm the drug is safe and effective.