Jazz targets US launch of SCLC drug after FDA grants fast review

PharmaMar and Jazz Pharmaceuticals have announced the FDA has granted a six-month Priority Review for their lurbinectedin for relapsed small cell lung cancer (SCLC).

The regulator will review a filing seeking approval in patients whose disease has progressed after platinum-containing therapy, and is due to make a decision on or before August 16 this year.

Madrid-based PharmaMar has a pipeline of oncology drugs that are inspired by compounds from the sea and already markets Yondelis (trabedectin), for soft tissue sarcoma and ovarian cancer.

The Spanish company described lurbinectedin as a selective inhibitor of the oncogenic transcription programmes on which many tumours are particularly dependent.

Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumour-associated macrophages that have been taken over by cancer, downregulating the production of cytokines that are essential for the growth of the tumour.

In December, PharmaMar signed a license agreement worth up to $1 billion, where the Dublin-based pharma paid $200 million up front in return for exclusive US marketing rights for lurbinectedin, with a further $250 million due if the FDA grants approval.

Jazz could also pay up to $550 million in commercial milestone payments, as well as incremental tiered royalties on future sales of lurbinectedin ranging from the high teens up to 30%.

The companies are targeting a niche where there has been little progress in terms of new drug treatments: the last approval in second line SCLC was the now-generic topotecan, which has been on the market since 1996.

There is indirect competition from Roche’s Tecentriq (atezolizumab), which was approved late last year in extensive-stage first-line SCLC.

PharmaMar’s filing is based on data from a phase 2 basket trial, involving 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 last year.