On January 31, 2023 PharmaMar (MSE:PHM) has reported that its licensing partner, Megapharm Ltd., has received the conditional marketing approval for Zepzelca (lurbinectedin) by the Ministry of Health of Israel 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, JAN 31, 2023, View Source [SID1234626665]).

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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 and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

Ali Zeaiter, M.D., VP Clinical Development & Regulatory Affairs of PharmaMar, said: "Lurbinectedin is an innovative medicine that shows clinical benefit for patients with relapsed Small Cell Lung Cancer (SCLC). This approval brings hope that, after two decades of no advances in second-line SCLC treatments, many patients with relapsed SCLC in Israel will have a new treatment option available."

In May 2020, PharmaMar and Megapharm signed a licensing agreement for lurbinectedin in Israel. This approval allows Megapharm to market lurbinectedin in Israel 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.