CdM | PharmaMar (PHM) informed the Spanish National Securities Market Commission (CNMV) on Monday that its drug Zepzelca (lurbinectedin), in combination with atezolizumab (Tecentriq), has been approved by the Taiwanese regulatory authority as a first-line maintenance treatment for adult patients with lung cancer of the small cell type at an advanced stage.
The approval means that the treatment will be administered following initial induction therapy to patients who have achieved disease stabilisation or improvement, with the aim of maintaining the response achieved.
With this decision, Taiwan joins other countries where this combination has already been authorised for the same indication, such as the United Arab Emirates, Oman, Israel, Uruguay, Ecuador, Paraguay and Peru, as well as the United States and Switzerland, where it was previously approved.
Furthermore, the company has noted that the marketing authorisation application is currently under reviewby the European Medicines Agency (EMA), as well as in other international markets.
Meanwhile, lurbinectedin monotherapy is already approved as a second-line treatment in 22 countries, i.e. for patients whose disease progresses during or after platinum-based chemotherapy.
Small cell lung cancer accounts for approximately 15% of lung cancer cases and is characterised by its high aggressiveness, with rapid growth and a tendency towards early spread.
PharmaMar markets its products outside Europe through agreements with strategic partners.
