A new drug application (NDA) will be submitted to the FDA under accelerated approval status for lurbinectedin monotherapy for the second-line treatment of patients with small cell lung cancer (SCLC), according to PharmaMar, the developer of the marine-derived agent.
In August 2018, the FDA granted lurbinectedin an orphan drug designation for the treatment of patients with SCLC. The designation facilitates the development and review of therapies in areas of high unmet medical need.
- PhamaMar will submit NDA for lurbinectedin under accelerated approval in SCLC in the USA. PharmaMar. Published August 19, 2019. https://bit.ly/2KIxMbF. Accessed August 19, 2019.
- Paz-Ares LG, Perez JMT, Besse B, et al. Efficacy and safety profile of lurbinectedin in second-line SCLC patients: Results from a phase II single-agent trial. J Clin Oncol. 2019;37(suppl; abstr 8506).
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