Is rubicatin/rubicatin on the market?

Lurbinectedin/Lurbinectedin is a DNA alkylating agent that has been studied for the treatment of a variety of cancers, including mesothelioma, chronic lymphocytic leukemia (CLL), breast cancer, and small cell lung cancer (SCLC). It is a derivative of the marine derivative trabectedin, an anticancer agent found in tunicate ascidian extracts. The main difference is that tetrahydroisoquinoline is replaced with tetrahydroisoquinoline, resulting in an increase in the anti-tumor activity of rubicatin.

On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval and orphan drug designation to rubicatin for the treatment of adult patients with metastatic small cell lung cancer who have experienced disease progression despite platinum-based therapy. The trade name isZepzelca. This accelerated approval is based on the rate and duration of treatment response observed in ongoing clinical trials and is dependent on verification of these results in confirmatory trials.

Marketing approval was based on the PM1183-B-005-14 trial (StudyB-005; NCT02454972), a multicenter, open-label, multi-cohort study of 105 patients with metastatic small cell lung cancer who had disease progression during or after platinum-based chemotherapy. Patients received 3.2 mg/m2 of lurbinectedin by intravenous infusion every 21 days until disease progression or unacceptable toxicity.

The primary efficacy outcome measures were confirmed overall response rate (ORR) and duration of response as determined by the investigators using RECIST 1.1 assessment. Among 105 patients, the ORR was 35% (95% CI: 26%-45%) and the median duration of response was 5.3 months (95% CI: 4.1-6.4). The independent review committee ORR was 30% (95% CI: 22%-40%), and the median duration of response was 5.1 months (95% CI: 4.9-6.4).