- A petition was filed requesting that the FDA initiate proceedings to withdraw approval of all medications containing lurbinectedin, currently marketed under the brand Zepzelca by Jazz Pharmaceuticals plc JAZZ.
- The FDA granted accelerated approval to lurbinectedin in June 2020 for metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
- Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- In December 2020, Jazz Pharmaceuticals and its partner PharmaMar announced data from ATLANTIS Phase 3 trial.
- The study did not meet the pre-specified criteria of significance for the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population comparing lurbinectedin in combination with doxorubicin to the control arm.
- The FDA agrees that the ATLANTIS trial's results are inadequate to verify and describe the clinical benefit of Zepzelca. It also says that when a confirmatory trial does not meet its endpoint, it does not necessarily mean that the drug is not effective for the indication approved through accelerated approval.
- The ATLANTIS trial used a different dosage regimen than the approved regimen in combination with doxorubicin. This raises the possibility that a primary reason for the ATLANTIS trial not meeting its primary endpoint may be that a lower dose of Zepzelca resulted in decreased efficacy relative to the approved dose.
- The agency also notes that there is still an unmet medical need for metastatic SCLC.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
