- 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 (NASDAQ: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.
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