PharmaMar has announced that its partner, Boryung Corporation, has received conditional approval from commercialization of Zepzelca® (lurbinectedin) by the Ministry of Food and Drug Safety (MFDS) of South Korea for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after chemotherapy. platinum.
this new lurbinectedin approval is based on clinical data from the single-arm, multicenter, open-label, monotherapy trial in 105 adult patients with recurrent metastatic small cell lung cancer (including patients with platinum-sensitive and platinum-resistant disease), which Food and Drug Administration (FDA) used to grant accelerated approval of lurbinectedin in the United States.
In November 2017, PharmaMar and Boryung signed a license agreement for lurbinectedin in South Korea. This approval will allow Boryung to market lurbinectedin in South Korea in the coming months.
Conditional approval is subject to confirmation from the phase III trial (LAGOON) in second-line small cell lung cancer, starting in December 2021.