PharmaMar seeks lurbinectedin temporary marketing authorization from Swissmedic

20 July 2020

Spanish drugmaker PharmaMar (MC: PHM) has submitted lurbinectedin (trade name Zepzelca) for “Temporary Authorization” for marketing to the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of patients with small cell lung cancer (SCLC) 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 SCLC. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, lurbinectedin demonstrated an Overall Response Rate (ORR) of 35% and a median Duration of Response (DoR) of 5.3 months, as measured by investigator assessment (30% and 5.1 months respectively, as measured by an independent review committee (IRC).

Streamlined procedure with shorter overall timelines

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