Biopharmaceutical company PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc (Nasdaq:JAZZ) on Friday jointly announced the submission of New Drug Application (NDA) under the US Food and Drug Administration's (FDA) priority review seeking accelerated approval of lurbinectedin for the treatment of Small Cell Lung Cancer (SCLC) following prior platinum-containing therapy.
The partnership added that the US FDA has set lurbinectedin's PDUFA target action date of 16 August 2020.
According to the partnership, Lurbinectedin (PM1183) is a selective inhibitor of the oncogenic transcription programmes on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor.
A total of 105 patients from 39 centre were recruited in Europe and the US as part of the partnership's Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. 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.
Under an exclusive license agreement, PharmaMar has granted Jazz US with the commercialization rights to lurbinectedin.
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Charles River Laboratories launches AMAP to reduce animal testing reliance
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
GSK's meningitis vaccine candidate accepted for FDA review
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
AbbVie announces interim evaluation of Atogepant Phase three, open-label 156-week extension study