FDA Turns Down Withdrawal Petition for Lung Cancer Drug Approval

The FDA has rejected a citizen petition calling for withdrawal of accelerated approval for Jazz Pharmaceuticals’ and PharmaMar’s Zepzelca (lurbinectedin), a treatment for adults with metastatic small cell lung cancer (SCLC).

The petition, filed in March 2021 by the law firm Foley Hoag, requested that the FDA pull its approval of the drug after a phase 3 confirmatory trial failed to demonstrate Zepzelca plus chemotherapy’s effectiveness in prolonging overall and progression-free survival in SCLC patients.

In its rejection letter, the FDA noted that the dosage regimen studied in the phase 3 trial — lurbinectedin 2 mg/m2 every 21 days in combination with doxorubicin — is not the same as the approved dosage regimen — lurbinectedin 3.2 mg/m2 every 21 days as a single agent.

The agency added that current labeling for Zepzelca “accurately presents the monotherapy and 3.2 mg/m2 dose results in the cohort of patients with SCLC” in the study that supported the accelerated approval.