PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer
PharmaMar and Jazz Pharmaceuticals Announce FDA Acceptance and Priority Review of New Drug Application for Lurbinectedin in Relapsed Small Cell Lung Cancer Prescription Drug User Fee Act (PDUFA) date set for August 16, 2020. |
[17-February-2020] |
MADRID and DUBLIN, Feb. 17, 2020 /PRNewswire/ -- PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announce that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of patients with Small Cell Lung Cancer (SCLC) who have progressed after prior platinum-containing therapy. The FDA has set a PDUFA target action date of August 16, 2020. PharmaMar submitted the NDA to FDA in December 2019 based on data from the Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. A total of 105 patients from 39 centers were recruited in Europe and the United States. The trial met its primary endpoint of the Objective Response Rate (ORR) and the results were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2019. The FDA's accelerated approval pathway allowed for the submission of an NDA based on the results of Phase II drug investigations for the treatment of serious diseases that address an unmet medical need. There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved. As previously announced in December 2019, PharmaMar and Jazz Pharmaceuticals have entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to lurbinectedin. About Lurbinectedin About PharmaMar PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com. About Jazz Pharmaceuticals PharmaMar Legal Statement PharmaMar Media and Investor Relations Contact Media Contact: Investor Relations: Jazz Pharmaceuticals Media and Investor Relations Contact Media Contact: Investor Contact:
View original content to download multimedia:http://www.prnewswire.com/news-releases/pharmamar-and-jazz-pharmaceuticals-announce-fda-acceptance-and-priority-review-of-new-drug-application-for-lurbinectedin-in-relapsed-small-cell-lung-cancer-301005785.html SOURCE Jazz Pharmaceuticals plc | ||
Company Codes: NASDAQ-NMS:JAZZ, SpanishCats:PHM |
© 2020 PR Newswire. All Rights Reserved.