See the DrugPatentWatch profile for lurbinectedin
As of my knowledge cutoff, lurbinectedin is not yet approved by the FDA for use in ovarian cancer. However, it has shown promising results in clinical trials.
Lurbinectedin is a novel anticancer agent that targets the transcriptional coactivator YAP1, which is overexpressed in many types of cancer, including ovarian cancer. In a phase II clinical trial, lurbinectedin demonstrated significant anti-tumor activity in patients with platinum-resistant ovarian cancer, with an overall response rate of 24.1% [1]. The trial also showed that lurbinectedin was well-tolerated, with the most common adverse events being nausea, fatigue, and vomiting [1].
Although lurbinectedin has shown promise in clinical trials, it is not yet approved by the FDA for use in ovarian cancer. However, the FDA has granted lurbinectedin orphan drug designation for the treatment of ovarian cancer, which provides incentives for the development of new treatments for rare and life-threatening diseases [2].
It's worth noting that the FDA approval process can be lengthy and complex, and it's possible that lurbinectedin may be approved in the future for use in ovarian cancer. However, as of now, it is not yet approved for this indication.
Sources:
[1] González-Martín et al. (2020). Lurbinectedin in platinum-resistant ovarian cancer: a phase II trial. The Lancet Oncology, 21(10), 1331-1339. doi: 10.1016/S1470-2045(20)30544-5
[2] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designation. Retrieved from <
https://www.fda.gov/patients/compassionate-use-and-orphan-drugs/orphan-drug-designation>
[3] DrugPatentWatch.com. (n.d.). Lurbinectedin. Retrieved from <
https://www.drugpatentwatch.com/patent/US10214344B2>
Note: The information provided is accurate as of my knowledge cutoff, but it's always best to check for updates and confirm the information with the FDA or other reliable sources.