Roche Gets FDA Priority Review for Non-Small Cell Lung Cancer Drug
FDA expects to make its decision on approval of Roche’s non-small cell lung cancer drug Tecentriq by December 2021.
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By - FDA recently accepted Roche’s biologics license application and granted priority review for Tecentriq as an adjuvant treatment following surgery and platinum-based chemotherapy for individuals with non-small cell lung cancer (NSCLC).
The agency is reviewing the application under the Real-Time Oncology Review pilot program, which focuses on a more efficient review process to ensure safe and effective treatments are available to patients as early as possible.
FDA expects to decide on approval of Tecentriq by December 2021.
“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, Roche’s chief medical officer and head of global product development, said in the announcement.
“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,” Garraway continued.
FDA based its decision on disease-free survival results from an interim analysis of Roche’s Phase III Impower010 study, which randomized 1,005 individuals to receive either Tecentriq or best supportive care.
Researchers found that Tecentriq following surgery and platinum-based chemotherapy reduced risk of disease recurrence or death by 34 percent in individuals with Stage II-IIA NSCLC whose tumors expressed PD-L1 compared with best supportive care.
The trial will continue to analyze recurrence of death and survival data in the overall population, including Stage IB patients. Notably, researchers found no new safety signals for Tecentriq.
About 1.8 million people die annually from lung cancer. And NSCLC is the most prevalent type of cancer, accounting for nearly 85 percent of all cases, a Roche spokesperson explained.
Impower010 is the first and only Phase III study of a cancer immunotherapy to elicit positive results in the adjuvant lung cancer setting.
In May 2020, FDA approved Roche’s Tecentriq for adult patients with metastatic non-small cell lung cancer based on results from the Impower110 trial.
Researchers found that median survival was 20.2 months for patients for Tecentriq compared with 13.1 months for chemotherapy.
Additionally, median progression-free survival per investigator was slightly more than eight months for Tecentriq and five months for platinum-based chemotherapy.
Overall response rate per investigator was 38 percent and 29 percent, respectively. Drug safety appeared to be consistent with its known safety profile, and no new safety signals were identified.
