FDA Grants Accelerated Approval for Keytruda in HNSCC

The accelerated approval is based on tumor response rate and durability of response
The accelerated approval is based on tumor response rate and durability of response

Merck announced that the Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 

The FDA's accelerated approval for this indication was based on tumor response rate and durability of response. Continued approval for this indication may be pending verification and description of clinical benefit in the confirmatory trials. 

The Phase 1b, multicenter, non-randomized, open-label, multi-cohort KEYNOTE-012 study (n=192) included patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy and ECOG performance status of 0 or 1. Study data showed an objective response rate (ORR) of 16% (95% CI: 11, 22), a complete response rate of 5% with responses of 6 months or longer seen in 82% of responsive patients. ORR and duration of response were comparable regardless of human papilloma virus (HPV) status. 

Keytruda, a human programmed death receptor-1 (PD-1)-blocking antibody, works by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor and healthy cells.  It is currently indicated for the treatment of patients with unresectable or metastatic melanoma and for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy.

Keytruda is available as a 50mg/vial lyophilized powder for IV infusion and as a 25mg/mL per val solution for IV infusion. For HNSCC patients, PD-L1 testing is not required prior to use of Keytruda.

For more information call (800) 672-6372 or visit Keytruda.com.

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