As per the new drug application (NDA) for lurbinectedin, which has been accepted for filing by the regulator, the two companies are seeking accelerated approval for its use in the treatment of the type of lung cancer in patients whose condition has progressed following prior platinum-containing therapy.
The FDA is expected to take a decision on the approval of the drug candidate by mid-August 2020, as per the prescription drug user fee act (PDUFA) target action date.
PharmaMar, which is a Spanish biopharma company, had submitted the NDA to the US drug regulator in December 2019 based on the findings of the phase 2 monotherapy basket trial.
The mid-stage trial involved the assessment of lurbinectedin for the treatment of relapsed SCLC in 105 patients across 39 centers in Europe and the US. The phase 2 trial met its primary endpoint of the objective response rate (ORR).
PharmaMar and Jazz Pharmaceuticals jointly stated: “The FDA’s accelerated approval pathway allowed for the submission of an NDA based on the results of Phase II drug investigations for the treatment of serious diseases that address an unmet medical need.
“There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved.”
In December 2019, PharmaMar signed a license agreement worth $1bn with the Ireland-based Jazz Pharmaceuticals to give the latter the US commercialisation rights to lurbinectedin.
The license agreement became effective in January 2020, thereby triggering an upfront payment of $200m to PharmaMar. The Spanish pharma company stands to receive up to another $800m subject to regulatory and commercial milestones achieved by lurbinectedin.
The synthetic compound is designed to be a selective inhibitor of the oncogenic transcription programmes on which several tumours are particularly dependent. Along with its effect on cancer cells, the compound is claimed to inhibit oncogenic transcription in tumour-associated macrophages, thereby downregulating the production of cytokines that are necessary for the growth of the tumour.