Merck has received breakthrough therapy designation from US Food and Drug Administration (FDA) for its Keytruda (pembrolizumab) to treat patients with epidermal growth factor receptor (EGFR) mutation-negative and anaplastic lymphoma kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC).
According to Merck, it is the second breakthrough therapy designation granted for Keytruda.
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Keytruda is a humanised monoclonal antibody, which blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Merck Research Laboratories president Dr Roger Perlmutte said: "The FDA’s breakthrough therapy designation of Keytruda underscores that new treatment approaches for advanced non-small cell lung cancer continue to be needed.
"Our data investigating the use of Keytruda in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical programme."
The FDA granted breakthrough therapy designation based on data from the ongoing Phase Ib KeynoteY-001 study.
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By GlobalDataIn the US, Keytruda received accelerated approval at a dose of 2mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
In advanced lung cancer, the company is carrying out a clinical programme investigating the use of Keytruda as monotherapy and in combination across lines of therapy and histology.
The two ongoing Phase II and III trials for advanced lung cancer include Keynote-010 and Keynote-024, and an additional Phase III trial is planned, which is expected to start in the fourth quarter of this year.
Image: Micrograph of small cell carcinoma of the lung, also small cell lung cancer. Photo: courtesy of Nephron.
