FDA accept ‘Priority Review’ for lurbinectedin in small-cell lung cancer

PharmaMar and Jazz Pharmaceuticals have just announced that the American regulatory agency FDA has accepted the Priority Review of lurbinectedin for the treatment of patients with small-cell lung cancer who have progressed to previous platinum treatment. This approval request is based on data from a phase II clinical trial, in which 105 patients with the disease received lurbinectedin as second-line treatment. The data was presented at the last congress of the American Society of Clinical Oncology (more info).

The FDA’s accelerated approval process allows the presentation of preliminary efficacy data on drugs that cover unmet medical needs, such as non-small cell lung cancer, a disease for which the last effective treatment (topotecan) was approved more than two decades ago.

In December 2019, PharmaMar and Jazz Pharmaceuticals signed an exclusive license agreement, whereby Jazz Pharmaceuticals acquires the commercialization rights of lurbinectedin in the US and PharmaMar receives a first payment of $ 200 million (more info)

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