FDA grants priority review to Tecentriq for early NSCLC
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The FDA granted priority review to atezolizumab as adjuvant treatment for certain people with non-small cell lung cancer.
The designation applies to use of the agent for people whose tumors express PD-L1 at a level of 1% or greater who underwent surgery and platinum-based chemotherapy.
The FDA is reviewing this application under its Real-Time Oncology Review pilot program, designed to accelerate the delivery of effective and safe cancer treatments to patients. The agency is expected to make a decision on approval by Dec. 1.
Atezolizumab (Tecentriq, Genentech/Roche) is an anti-PD-L1 monoclonal antibody approved in the United States for multiple lung cancer indications.
“New treatment options are urgently needed in early-stage non-small cell lung cancer to help the nearly 50% of people who currently experience a recurrence following surgery,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release. “Tecentriq is the first cancer immunotherapy to show a clinically meaningful benefit in the adjuvant lung cancer setting, and we’re working closely with the FDA to bring this significant advancement to patients as quickly as possible.”
The FDA based the priority review on results of the randomized phase 3 IMpower010 study, which evaluated the efficacy and safety of atezolizumab for patients with stage IB to stage IIIA NSCLC who underwent surgical resection and up to four cycles of adjuvant cisplatin-based chemotherapy.
Researchers randomly assigned 1,005 patients to up to 16 cycles of atezolizumab or best supportive care.
Investigator-assessed DFS among three groups — patients with PD-L1-positive stage II to stage IIIA disease, all randomly assigned patients with stage II to stage IIIA disease, and all patients in the intention-to-treat population with stage IB to stage IIIA disease — served as the primary endpoint. Secondary endpoints included OS in the entire study population and patients in the intention-to-treat population with stage IB to stage IIIA disease.
As Healio previously reported, results presented at this year’s virtual ASCO Annual Meeting showed atezolizumab reduced risk for disease recurrence or death by 34% (HR = 0.66; 95% CI, 0.5-0.88) among patients with stage II to stage IIIA NSCLC whose tumors expressed PD-L1 at a level of 1% or greater. In this group, median DFS had not been reached with atezolizumab and was 35.3 months for best supportive care.
Safety data appeared consistent with atezolizumab’s known safety profile. Researchers identified no known safety signals.
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