FDA grants priority review for Jazz, PharmaMar's lurbinectedin in second-line SCLC

Jazz Pharmaceuticals and PharmaMar said Monday that a filing seeking accelerated approval of lurbinectedin will be assessed under a priority review by the FDA for the treatment of patients with small-cell lung cancer (SCLC) who have progressed after prior platinum-containing therapy. The regulator is expected to render its decision on the application by August 16.

The filing is based on data from a Phase II monotherapy basket trial, which included evaluation of lurbinectedin for the treatment of relapsed SCLC. The trial of 105 second-line SCLC patients met its primary endpoint of objective response rate (ORR), with results presented at last year's American Society of Clinical Oncology (ASCO) annual meeting showing that an ORR of 35.2% was achieved in the total study population. Meanwhile, among patients with sensitive or resistant disease, the ORRs were 45% and 22.2%, respectively.

"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…topotecan was approved," the companies noted. In December, Jazz agreed to pay PharmaMar $200 million upfront as part of an exclusive license agreement for lurbinectedin in the US.

According to the companies, lurbinectedin, also known as PM1183, is a synthetic compound that inhibits oncogenic transcription in tumour-associated macrophages. The agent was previously granted orphan drug designation by the FDA in the SCLC indication.

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