PharmaMar (MSE:PHM) has announced today that its licensing partner, Lotus Pharmaceutical CO., Ltd. (TWSE:1795), has received accelerated marketing approval for Zepzelca^® (lurbinectedin) by the Taiwan Food and Drug Administration (TFDA), for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy. It had been more than 10 years since a drug had been approved in Taiwan for this therapeutic indication.

This new approval of lurbinectedin is based on the data from the open-label, multi-center, single-arm monotherapy 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.

In November 2021, PharmaMar and Lotus Pharmaceutical signed a licensing agreement for lurbinectedin in Taiwan. Under the terms of the agreement PharmaMar will retain production rights and will sell the product to Lotus for its clinical and commercial use, while Lotus will pursue the marketing approval in Taiwan and have the right to market the compound exclusively.

The approval is subject to confirmation with a Phase III clinical trial. With this approval in Taiwan, lurbinectedin is now approved in 12 countries around the world.

About 15% of all lung cancers are Small Cell Lung Cancer (SCLC). This type of lung cancer tends to grow and spread faster than Non Small Cell Lung Cancer. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed [1].