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# Regulatory Review Period for Zepzelca
- URL: https://www.fdaweb.com/regulatory-review-period-for-zepzelca/
- Published: 2021-11-29T12:00:00.000Z
- Updated: 2026-09-14T17:23:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150652

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Pharma Mar’s Zepzelca (lurbinectedin), indicated for treating adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy. The review period is 4,170 days, which includes 3,987 days that occurred during the testing phase and 183 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-26009.pdf?ref=fdaweb.com).