FDA Declines Eli Lilly’s Letter for Non-Small Cell Lung Cancer Drug
FDA stated that it is unable to approve Eli Lilly’s application for its non-small cell lung cancer drug in its current form and recommended an additional multiregional clinical trial.
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By - FDA recently issued a complete response letter (CRL) for Eli Lilly and Company’s biologics license application (BLA) for its combination antibody therapy, sintilimab, to treat nonsquamous non-small cell lung cancer (NSCLC).
In the CRL, FDA stated that the review cycle of sintilimab is complete. But the agency is unable to approve the application in its current form.
Specifically, FDA recommended an additional multiregional clinical trial comparing standard of care therapy for first-line metastatic NSCLC to sintilimab with chemotherapy, utilizing a non-inferiority design with an overall survival endpoint.
Eli Lilly stated that it will assess the next steps for the sintilimab program in the US.
Lung cancer is the leading cause of cancer deaths globally among men and women (25%). The two main types of lung cancer are non-small cell and small cell. NSCLC is one of the most common types of lung cancer, representing up to 84% of diagnoses.
While surgery has cured many patients with NSCLC, between 30% and 55% experience recurrence after surgery and ultimately die from the disease.
In December 2021, Eli Lilly and Company and biopharmaceutical company Innovent agreed to co-develop and commercialize oncology medicines, including sintilimab.
Sintilimab is an immunoglobulin G4 monoclonal antibody combined with pemetrexed and platinum chemotherapy that binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-L1 pathway, and reactivates T-cells to kill cancer cells.
Innovent is currently conducting over 20 clinical studies to evaluate sintilimab’s safety and efficacy in various cancer indications, including more than 10 registrational or pivotal trials.
And last year, sintilimab was successfully included in China’s updated National Reimbursement Drug List (NRDL) for all four approved indications.
The total indications for the drug include one approval in combination with pemetrexed and platinum chemotherapy to treat advanced or recurrent nonsquamous NSCLC and one approval in combination with gemcitabine and platinum chemotherapy to treat advanced or recurrent NSCLC.
Additionally, sintilimab is approved in combination with Byvasda to treat unresectable or advanced hepatocellular carcinoma (HCC) and for relapsed or refractory classic Hodgkin’s lymphoma (cHL) after two lines or later of systemic chemotherapy.
