FDA approves Zepzelca + Tecentriq combination as first-line maintenance therapy for ES-SCLC

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FDA has granted a approval for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) as a maintenance treatment for adults with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

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Vinay Prasad, FDA’s chief medical and scientific officer and director of the agency’s Center for Biologics Evaluation and Research, has instructed his staff to check with him before continuing to work on ongoing submissions to journals or beginning new contract-funded projects to “ensure that we are not engaging in sunk cost fallacy, not publishing obviously erroneous work, and not being distracted from our core mission.”

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