PharmaMar has announced, along with Jazz Pharmaceuticals, which the United States FDA (Food and Drug Administration) has approved ZepzelcaTM (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer with disease progression after platinum-based chemotherapy treatment.
This approval will allow Jazz to make lurbinectedin (ZepzelcaTM) commercially available in the US in early July of the same year. As previously reported on December 19, 2019, PharmaMar will receive royalties on lurbinectedin's net sales whose range ranges from double high digits, up to a maximum of 30%.
Further, PharmaMar will enter a payment of 100 million dollars and could receive up to another 150 million additional once the “full approval” occurs.
Lurbinectedin has been approved under Accelerated Approval based on Overall Response Rate (ORR) and Duration of Response (DoR).
FDA approval of this drug is based on data from a single-arm, multi-center, single-arm study of 105 adult patients sensitive to platinum and resistant to platinum, with recurrent small cell lung cancer.
The data, which was published in the May 2020 issue of The Lancet Oncology, showed that lurbinectedin in recurrent small cell lung cancer showed an ORR of 35% and a median DoR of 5.3 months according to the researcher's evaluation (30% and 5.1 months respectively, as measured by the Independent Review Committee (IRC).
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