PharmaMar announces the approval of Zepzelca® (lurbinectedin) for the treatment of metastatic Small Cell Lung Cancer in South Korea

On September 23, 2022 PharmaMar (MSE:PHM) reported that its licensing partner, Boryung Corporation, has received the conditional marketing approval for 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 (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, SEP 23, 2022, View Source [SID1234621377]).

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This new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multi-center, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive, resistant and refractory disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In November 2017, PharmaMar and Boryung signed a licensing agreement for lurbinectedin in South Korea. This approval allows Boryung to market lurbinectedin in South Korea in the following months.

The conditional approval is subject to confirmation with the LAGOON Phase III clinical trial in 2nd line SCLC, initiated in December 2021.