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