Zepzelca

Treats extensive-stage small cell lung cancer. NDA 213702, held by Jazz. Lurbinectedin.

As of Nov 13, 2026, NDA 213702 (Zepzelca), held by Jazz, was first approved by FDA on Jun 15, 2020, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2020
Review: Priority
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZEPZELCA is an alkylating drug indicated:

in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Oct 2, 2025	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 15, 2020	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zepzelca4MG/VIAL · powder;intravenous	Lurbinectedin	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Sep 30, 2026	Supplement 13Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 27, 2026	Supplement 12Labeling · Standard review	Approved	Label Letter
Oct 2, 2025	Supplement 11Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 30, 2025	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 28, 2023	Supplement 8Labeling · Standard review	Approved	Label Letter
Apr 1, 2022	Supplement 4Labeling · Standard review	Approved	Label Letter
Jun 15, 2020	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 213702
Drugs@FDA: Overview at FDA
Company: Jazz Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters