FDA News

Keytruda receives FDA breakthrough therapy designation, priority review for first-line NSCLC

The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.

The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.

All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.

Patients treated with pembrolizumab demonstrated superior PFS and OS compared with those treated with chemotherapy.

Based on these results, the trial concluded early to offer patients on the chemotherapy arm the opportunity to receive pembrolizumab.

The target action date for this application is Dec. 24, 2016.

“Chemotherapy has been the foundation of first-line treatment for non–small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with pembrolizumab compared with chemotherapy is welcome news,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “We appreciate the opportunity to work with regulatory authorities to make pembrolizumab a first-line treatment option in non–small cell lung cancer.”

Pembrolizumab — a humanized monoclonal antibody — is approved for treatment of unresectable or metastatic melanoma; metastatic, PD-L1–expressing NSCLC that progressed on or after platinum-containing chemotherapy; and recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy. The agent also has received breakthrough therapy designation for microsatellite instability high metastatic colorectal cancer and relapsed or refractory classical Hodgkin lymphoma.

A marketing authorization application has also been submitted to the European Medicines Agency for this indication.

The FDA today granted breakthrough therapy designation and priority review to pembrolizumab for the first-line treatment of patients with advanced non–small cell lung cancer whose tumors express PD-L1, according to the drug’s manufacturer.

The phase 3 KEYNOTE-024 study — designed to compare pembrolizumab (Keytruda, Merck) monotherapy with standard chemotherapy — included 305 patients with advanced disease.

All patients’ tumors expressed high levels of PD-L1, defined as a tumor proportion score of 50% or more, and no patients had received prior systemic chemotherapy for their disease.

Patients treated with pembrolizumab demonstrated superior PFS and OS compared with those treated with chemotherapy.

Based on these results, the trial concluded early to offer patients on the chemotherapy arm the opportunity to receive pembrolizumab.

The target action date for this application is Dec. 24, 2016.

“Chemotherapy has been the foundation of first-line treatment for non–small cell lung cancer for decades, so the significant improvement in survival in patients with high PD-L1 expression seen with pembrolizumab compared with chemotherapy is welcome news,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. “We appreciate the opportunity to work with regulatory authorities to make pembrolizumab a first-line treatment option in non–small cell lung cancer.”

Pembrolizumab — a humanized monoclonal antibody — is approved for treatment of unresectable or metastatic melanoma; metastatic, PD-L1–expressing NSCLC that progressed on or after platinum-containing chemotherapy; and recurrent or metastatic head and neck squamous cell carcinoma that progressed on or after platinum-containing chemotherapy. The agent also has received breakthrough therapy designation for microsatellite instability high metastatic colorectal cancer and relapsed or refractory classical Hodgkin lymphoma.

A marketing authorization application has also been submitted to the European Medicines Agency for this indication.

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