PharmaMar (MSE: PHM) today announced that its partner, Lotus Pharmaceutical CO., Ltd. (TWSE: 1795), has received accelerated marketing approval for Zepzelca (lurbinectedin) from the Taiwan Food and Drug Administration (PSDT), for the treatment of adult patients with metastatic small cell lung cancer with disease progression during 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 accelerated approval of lurbinectedin is based on clinical data from the single-arm, multicenter, open-label monotherapy trial conducted in 105 adult patients with recurrent metastatic small cell lung cancer (including patients with platinum-sensitive and platinum-resistant disease), used by the Food and Drug Administration (FDA) to grant accelerated approval for lurbinectedin in the United States.

In November 2021, PharmaMar and Lotus Pharmaceutical signed a license and commercialization agreement for lurbinectedin in Taiwan. Under the terms of the agreement, PharmaMar retains production rights and will sell the product to Lotus for clinical and commercial use, while Lotus will have the right to exclusively market the product.

Approval is subject to confirmation by a phase III trial. With this approval in Taiwan, lurbinectedin has gained approval in 12 countries around the world.

About 15% of all lung cancers are small cell or small cell lung cancer. This type of lung cancer usually grows and spreads faster than non-small cell lung cancer. In most people with small cell lung cancer, the cancer has spread beyond the lungs by the time it is diagnosed [1] .

Contact:

Tel: +34 91 846 6000

Fax: 91 846 6001

Email: pharmamar@pharmamar.com

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