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PharmaMar and Jazz Receive the US FDA's Priority Review Acceptance of Lurbinectedin's NDA for Patients with Relapsed Small Cell Lung Cancer

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PharmaMar and Jazz Receive the US FDA's Priority Review Acceptance of Lurbinectedin's NDA for Patients with Relapsed Small Cell Lung Cancer

Shots:

  • The US FDA has accepted NDA filing with PR seeking accelerated approval for lurbinectedin to treat patients with SCLC having diseases progression following the prior treatment of platinum-containing therapy
  • The NDA submission is based on P-II monotherapy basket study assessing lurbinectedin in 105 patients with SCLC at 39 centers across the US & EU that resulted in meeting its 1EPs of ORR
  • Lurbinectedin (PM1183) is a selective inhibitor of the oncogenic transcription programs on which tumors are dependent- with its anticipated PDUFA date as of Aug 16- 2020. In Dec’2019- PharmaMar and Jazz signed an exclusive license for lurbinectedin- which became effective in Jan’2020- granting US commercial rights of the therapy to the Jazz

Click here ­to­ read full press release/ article | Ref: Jazz Pharmaceutical | Image: Twitter


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