FDA Grants Priority Review for Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination in Extensive Stage Small Cell Lung Cancer

PharmaMar (MSE:PHM) has announced that the U.S Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab. The FDA’s Priority Review designation is assigned to applications for drugs that would offer a significant improvement in the safety or effectiveness of the treatment of a serious condition and means FDA’s goal is to take action on the NDA within six months (compared to ten months under standard review). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 7, 2025. Jazz Pharmaceuticals plc (Nasdaq: JAZZ), PharmaMar’s partner in the U.S., submitted the sNDA to the FDA in April based on data from the Phase 3 IMforte trial, which evaluated lurbinectedin plus atezolizumab as a first-line maintenance therapy in patients with ES-SCLC. 483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the lurbinectedin plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone. From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively. Data from the trial served as the basis, also, for the recent submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar. PharmaMar informs that Slingshot will host a Key Opinion Leader webcast on June 12th at 17:00h CEST / 11:00 EDT to review the Phase 3 IMforte data for lurbinectedin + atezolizumab in extensive-stage small cell lung cancer, which were presented at ASCO, as well as the treatment landscape. The webcast will include a discussion panel of Dr. Martin Wermke from TU Dresden and Dr. Nicolas Girard from Institut Curie. The webcast may be accessed from the Investors section at https://pharmamar.com/en/

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