Trabectedin for Injection is a chemotherapeutic agent that has received tentative approval from the U.S. FDA under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This drug is primarily administered via intravenous injection, and it is designed to work by interfering with the DNA of cancer cells, thereby inhibiting their ability to divide and grow. The mechanism of action of Trabectedin involves DNA minor groove binding and intercalation, leading to the disruption of DNA transcription and repair, which ultimately induces cell death, particularly in neoplastic tissues.

Although the drug has achieved tentative approval, it is not yet authorized for marketing until the expiration of relevant patent protections and resolution of any ongoing legal issues related to patent infringement claims. This status means that the drug cannot be legally marketed, and its labeling cannot be used for public distribution until the FDA issues its final approval. The final approval will depend on further court proceedings related to patent disputes and the resolution of exclusivity protections.