Posted by Michael Wonder on 21 Jul 2020
PharmaMar has filed lurbinectedin for Temporary Marketing Authorisation with the Swiss Agency for Therapeutic Products
20 July 2020 - The filing is based on the Phase II multi-centre basket trial efficacy data.
PharmaMar has announced that it has submitted lurbinectedin for “Temporary Authorisation” for marketing to the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with small-cell lung cancer who have progressed after prior platinum-containing therapy.
This filing is based on data from the phase II monotherapy basket trial with lurbinectedin for the treatment of patients with small cell lung cancer. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in patients with relapsed small-cell lung cancer, lurbinectedin demonstrated an overall response rate of 35% and a median duration of response of 5.3 months, as measured by investigator assessment (30% and 5.1 months respectively), as measured by an independent review committee.
