FDA approves Regeneron & Sanofi’s Libtayo for advanced non-small cell lung cancer
pharmafile | February 23, 2021 | News story | Manufacturing and Production | Cancer, Sanofi
The FDA has approved Regeneron & Sanofi’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression, as determined by an FDA-approved test.
Patients must either have metastatic or locally advanced tumours that are not candidates for surgical resection or definitive chemoradiation, and the tumours must not have EGFR, ALK, or ROS1 aberrations.
This is Libtayo’s third approval, and follows a Priority Review by the FDA, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions. Earlier this month, the drug was approved as the first immunotherapy indicated for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, with full approval granted for locally advanced disease and accelerated approval granted for metastatic disease.
In 2018, Libtayo was the first systemic treatment approved for adults with advanced cutaneous squamous cell carcinoma that is locally advanced or metastatic and who are not candidates for curative surgery or curative radiation. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo.
The FDA’s approval in this indication is based on an analysis of 710 patients who were randomised to receive treatment in a Phase III trial; eligible patients were intended to have PD-L1 expression of at least 50%. Among these participants, Libtayo reduced the risk of death by 32% compared with chemotherapy.
Lung cancer is the leading cause of cancer death globally. In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed worldwide and in the US, respectively. Around 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages, and an estimated 25% to 30% of cases expected to test positive for PD-L1 in at least 50% of tumour cells.
Dr Naiyer Rizvi, Price Family Professor of Medicine, Director of Thoracic Oncology, Co-director of Cancer Immunotherapy at Columbia University Irving Medical Center, and a steering committee member of the trial, said: “The approval of Libtayo to treat first-line advanced non-small cell lung cancer with high PD-L1 expression means physicians and patients have a potent new treatment option against this deadly disease.
“Notably, Libtayo was approved based on a pivotal trial where most chemotherapy patients crossed over to Libtayo following disease progression, and that allowed for frequently underrepresented patients who had pretreated and clinically stable brain metastases, or who had locally advanced disease and were not candidates for definitive chemoradiation. This gives doctors important new data when considering Libtayo for the varied patients and situations they treat in daily clinical practice.”
Darcy Jimenez
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