Lilly issues Complete Response Letter for Sintilimab in combination with Pemetrexed and Platinum chemotherapy for NSCLC treatment
The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February
Eli Lilly and Company yesterday announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the Biologics License Application (BLA) for the investigational medicine Sintilimab injection, a PD-1 inhibitor in combination with Pemetrexed and Platinum chemotherapy for the first-line treatment of people with nonsquamous Non-Small Cell Lung Cancer (NSCLC). Sintilimab is being developed by Innovent Biologics and Lilly, according to a company statement.
The letter indicates that the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February. The CRL includes a recommendation for an additional clinical study, specifically a multi-regional clinical trial comparing standard of care therapy for first-line metastatic NSCLC to Sintilimab with chemotherapy utilising a non-inferiority design with an overall survival endpoint.
Along with Innovent, Lilly is assessing next steps for the Sintilimab programme in the US, concluded the statement.
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