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

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

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

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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