The Swiss Group for Clinical Research on Cancer recently organized a symposium on small cell lung cancer in Bern, on the occasion of the SAKK Meeting, an annual appointment that brings together numerous Swiss and international experts.
The occasion was the approval in Switzerland of the therapy with Lurbinectedin (Zepzelca*) for small cell lung cancer (SCLC) or microcytic. After the United States, where there has been an ‘accelerated approval’ by the FDA, and already 13 countries in the world, including Oman a few days ago. At present, this type of lung cancer has very few therapeutic options and the treatment with lurbinectedin, produced by PharmaMar, is not only effective in both resistant patients and in those sensitive to platinum in the first instance but it is also simple to manage with side effects that are easy to handling and regression. While waiting for the therapy to be examined by the European Medicines Agency (EMA) and therefore also available in our country, a treatment has therefore been approved a few steps from Italy, which can respond after twenty years to the unsatisfied needs of many patients with SCLC.
«Switzerland is the first country on the European continent to approve lurbinectedin- he says Luis Mora, managing director of PharmaMar-. And it will be marketed directly by the PharmaMar team in Europe. This approval brings hope to many patients with metastatic SCLC in Switzerland, who will now have a new treatment option». The symposium in Bern was chaired by Solange Peters, professor and program director of medical oncology and thoracic malignancies at the oncology department of the University Hospital Center of Vaud (CHUV) in Lausanne and former president of ESMO and saw the also participation of internationally renowned oncologists, such as Luis Paz-Ares, head of the Oncology Service of the 12 de Octubre Hospital in Madrid, who led the clinical trial of the phase II basketball study, thanks to which lurbinectedin was approved in several countries, including Switzerland.
It was thanks to the good results of this study that, in August 2019, the company agreed with the North American Drug Agency (FDA) to submit the registration application for the second-line treatment of small cell lung cancer and for which it received approval in June 2020. About 15% of all lung cancers are small cell, very aggressive disease, which tend to grow and spread quickly. In most people with SCLC, the cancer has already spread beyond the lungs by the time they are diagnosed. Lurbinectedin, also known as PM1183, is an analogue of the marine compound ET-736 isolated from sea squirt Ecteinascidia turbinata, in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of oncogenic transcription and, together with its effect on tumor cells, inhibits oncogenic transcription in tumor-associated macrophages, thereby affecting the micro-environment of the cell, essential for tumor growth.
So now also Switzerland, through the Regulatory Agency for Therapeutic Products (Swissmedic), has conditionally approved the marketing of lurbinectedin, for the treatment of adult patients with metastatic SCLC with disease progression during or after platinum-based chemotherapy and without metastases in the central nervous system. Conditional authorization is granted under certain conditions defined by law, in order to make medicines for the treatment of life-threatening diseases with limited treatment options available to patients as quickly as possible. The Lagoon clinical study will be the confirmatory one. In the meantime, if a patient cannot enter the clinical trial, you will be able to access the drug through an international purchase system from Switzerland (‘foreign medicine use or importation of medicines registered abroad’) to be agreed with your treating oncologist.