FDA News

FDA approves Tecentriq for certain patients with metastatic lung cancer

The FDA approved atezolizumab for the treatment of certain patients with metastatic non–small cell lung cancer, according to a press release issued by the agent’s manufacturer.

The approval allows for the use of atezolizumab (Tecentriq, Genentech) — a PD-L1 inhibitor — by patients whose disease progressed during or after platinum-containing chemotherapy, and whose disease progressed on an FDA–approved targeted therapy if their tumor harbors an ALK or EGFR abnormality.

“Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the press release. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”

The FDA based the approval on results from the randomized phase 3 OAK trial, as well as the phase 2 POPLAR study.

The OAK trial enrolled 850 patients with squamous and nonsquamous disease, regardless of PD-L1 status. Researchers randomly assigned patients 1:1 to atezolizumab or docetaxel chemotherapy.

Results showed patients treated with atezolizumab achieved significantly longer median OS than those treated with docetaxel (13.8 months vs. 9.6 months; HR = 0.74; 95% CI, 0.63-0.87).

The POPLAR trial enrolled 287 patients assigned atezolizumab (n = 144) or docetaxel (n = 143).

Results showed those assigned atezolizumab achieved significantly longer median OS (12.6 months vs. 9.7 months; HR = 0.69; 95% CI, 0.52-0.92). Objective response rate was the same in the atezolizumab and docetaxel groups (15% each), but the median duration of response was considerably longer among patients assigned atezolizumab (18.6 months vs. 7.2 months).

The most common side effects associated with atezolizumab treatment in patients with metastatic NSCLC include fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain and constipation.

The FDA approved atezolizumab for the treatment of certain patients with metastatic non–small cell lung cancer, according to a press release issued by the agent’s manufacturer.

The approval allows for the use of atezolizumab (Tecentriq, Genentech) — a PD-L1 inhibitor — by patients whose disease progressed during or after platinum-containing chemotherapy, and whose disease progressed on an FDA–approved targeted therapy if their tumor harbors an ALK or EGFR abnormality.

“Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the press release. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”

The FDA based the approval on results from the randomized phase 3 OAK trial, as well as the phase 2 POPLAR study.

The OAK trial enrolled 850 patients with squamous and nonsquamous disease, regardless of PD-L1 status. Researchers randomly assigned patients 1:1 to atezolizumab or docetaxel chemotherapy.

Results showed patients treated with atezolizumab achieved significantly longer median OS than those treated with docetaxel (13.8 months vs. 9.6 months; HR = 0.74; 95% CI, 0.63-0.87).

The POPLAR trial enrolled 287 patients assigned atezolizumab (n = 144) or docetaxel (n = 143).

Results showed those assigned atezolizumab achieved significantly longer median OS (12.6 months vs. 9.7 months; HR = 0.69; 95% CI, 0.52-0.92). Objective response rate was the same in the atezolizumab and docetaxel groups (15% each), but the median duration of response was considerably longer among patients assigned atezolizumab (18.6 months vs. 7.2 months).

The most common side effects associated with atezolizumab treatment in patients with metastatic NSCLC include fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain and constipation.

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