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FDA Rejects Request to Approve Novel Drug Combination in NSCLC


The FDA’s decision follows a recommendation from a panel of experts that suggested the agency not approve sintilimab plus the chemotherapy pemetrexed and platinum-based chemotherapy for patients with non-squamous non-small cell lung cancer.

The Food and Drug Administration (FDA) recently rejected a request from Eli Lilly to introduce an investigational drug into the market as a first-line treatment option for patients with non-squamous non-small cell lung cancer (NSCLC), according to a news release from the pharmaceutical company.

The injectable anti-PD-1 monoclonal antibody, known as sintilimab, was being investigated in combination with the chemotherapy pemetrexed and platinum-based chemotherapy in patients with stage 3b/c or stage 4 disease that did not harbor epidermal growth factor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

The decision follows a recommendation made during a February Oncologic Drugs Advisory Committee (ODAC) Meeting. ODAC comprises a panel of experts who review and evaluate data on the safety and efficacy of newer cancer drugs. After conducting their reviews, the panel often makes a recommendation to either approve or reject an application for a drug approval. Of note, the FDA does not have to follow the recommendations of the committee.

The panel of experts ruled that the data being presented by the manufacturer relied strictly on results from a patient population in China and failed to fulfill an unmet need. In fact, the committee concluded that the combination provided no advantage in safety or mode of administration for a United States patient population.

Moreover, the panel concluded that the patients included in this trial should be a part of a significantly larger multiregional clinical trial. “Multiregional clinical trials should be strategically conducted with global participation to ensure broad access for all patients in all regions of the world,” the panel wrote in a briefing document regarding its decision.

Eli Lilly and China-based Innovent Biologics, according to the release, are assessing next steps for the sintilimab regimen in the United States.

Of note, sintilimab is approved in China to treat relapsed or refractory classic Hodgkin lymphoma, as well as non-squamous NSCLC and hepatocellular carcinoma.

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