PharmaMar has filed for approval of lurbinectedin for the treatment of metastatic Small Cell Lung Cancer in the UK

This conditional registration application is based on data from the Phase II basket trial with lurbinectedin in monotherapy. In addition, the LAGOON Phase III trial could be used as a confirmatory trial. Lurbinectedin represents an important advance for adult patients whose metastatic Small Cell Lung Cancer has progressed after a first line treatment. PharmaMar (MSE:PHM) has announced today that it has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application is to seek approval for treatment with Zepzelca® (lurbinectedin) in adult patients with metastatic Small Cell Lung Cancer (SCLC) who have progressed following prior platinum-based chemotherapy. This registration application is based on data from the Phase II basket trial with lurbinectedin, in monotherapy, for the treatment of SCLC. This is the same trial that was used for the conditional approval of lurbinectedin in the US for the same indication and whose results were presented at the American Society of Clinical Oncology, ASCO, meeting in June 2019. Lurbinectedin received “Accelerated Approval” from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. In 2021, lurbinectedin also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore. According to regulations, an accelerated authorization requires a confirmatory trial, so PharmaMar announced in December 2021 the start of a confirmatory Phase III clinical trial, LAGOON, evaluating lurbinectedin for the treatment of patients with recurrent SCLC, which will also be used to apply for registration in Europe.

The release as fetched from its publisher. pharmamar.com ↗