FDA approval for Jazz and PharmaMar’s Zepzelca in metastatic small cell lung cancer

pharmafile | June 17, 2020 | News story | Manufacturing and Production, Research and Development, Sales and Marketing Cancer, FDA, PharmaMar, Zepzelca, jazz pharma, lung cancer 

The FDA has awarded approval to Jazz Pharma and PharmaMar for Zepzelca (lurbinectedin) as a treatment for metastatic small cell lung cancer (SCLC) in adult patients who have seen their disease progress following platinum-based chemotherapy, it has emerged.

The decision, made under the US agency’s accelerated approval pathway, was based on Phase 2 data drawn from 105 participants across 26 European hospitals. Principally, it was found that the drug generated an overall response rate of 35%, with a median duration of response of 5.3 months

“Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy,” commented Bruce Cozadd, Chairman and CEO of Jazz Pharmaceuticals. “While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.”

Jazz signed a partnership with PharmaMar in December last year to secure commercialisation rights to Zepzelca. The pair confirmed that the therapy will now be made available on the US market in early July.

Matt Fellows

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