Drugs

FDA Explains Why Zepzelca Will Not be Withdrawn

David McFarland

— 2 min read
Share

FDA says it does not believe Jazz Pharmaceuticals’ Zepzelca (lurbinectedin) should be withdrawn from the market as requested in a 3/4/21 petition filed by law firm Foley Hoag. The agency denied all elements of the petition except the one asking FDA to explain the basis for allowing the lung cancer drug to remain on the market.

The FDA response says Zepzelca injection was approved on 6/15/20 for intravenous use, under the accelerated approval pathway, to treat adult patients with metastatic small-cell lung cancer with disease progression on or after platinum-based chemotherapy. It is indicated for use as a single agent.

The petition asked that FDA:

  • initiate proceedings to withdraw approval of all medications containing lurbinectedin;
  • initiate proceedings to place lurbinectedin on the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness;
  • until the drug is withdrawn, require that the label be revised and updated to reflect the failure of the ATLANTIS trial to demonstrate the drug’s effectiveness in terms of overall survival and progression-free survival;
  • in the event that FDA does not initiate proceedings to withdraw approval, explain the basis for permitting the drug to remain on the market; and
  • in the event FDA does not withdraw approval, issue guidance clarifying the significance of confirmatory trials and explaining the circumstances under which the results of a confirmatory trial would lead to the withdrawal of a drug.

FDA says that while it agrees that the ATLANTIS results are not adequate to verify and describe Zepzelca’s clinical benefit, it does not agree the agency should initiate proceedings to withdraw the drug’s approval. “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,” FDA says. “When considering if withdrawal of an indication is appropriate or if additional confirmatory trials are warranted, FDA reassesses the medical need and available therapies to determine whether the conditions for accelerated approval still exist. If there are clear reasons that FDA agrees likely caused or contributed to the failure of a confirmatory trial to achieve its primary endpoint and an unmet medical need still exists, FDA may consider it in the best interest of the public health to work with companies to identify subsequent trials to verify clinical benefit while retaining the original accelerated approval on the market.”

The letter points out that ATLANTIS used a different dosage regimen than the approved indication and used Zepzelca in combination with doxorubicin, although the approved indication is as a single agent. FDA says it has reached an agreement with Jazz on the design of subsequent planned confirmatory trials.

Read more