The US Food and Drug Administration (FDA) has granted priority review for Roche’s monoclonal antibody, Tecentriq (atezolizumab), as adjuvant therapy for non-small cell lung cancer (NSCLC).
The agency accepted the supplemental biologics license application (sBLA) for the drug’s use in NSCLC patients with PD-L1 ≥1%-expressing tumours after surgery and platinum-based chemotherapy.
The FDA is conducting a review of the application as part of the Real-Time Oncology Review pilot programme. A regulatory decision is anticipated by 1 December.
Roche based the sBLA on disease-free survival (DFS) data from an interim analysis of the Phase III IMpower010 clinical trial.
In the trial, when administered after surgery and chemotherapy, the drug lowered the disease recurrence or death risk by 34%, compared to best supportive care (BSC), in Stage II-IIIA NSCLC patients with PD-L1 ≥1%-expressing tumours.
So far, the median DFS was not attained for Tecentriq as against 35.3 months for BSC.
Tecentriq safety data in the trial was in line with its already known safety profile, without new safety signals detected.
Roche noted that the antibody is the first-ever cancer immunotherapy to show favourable Phase III results in the adjuvant lung cancer setting.
Roche chief medical officer and Global Product Development head Levi Garraway said: “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.
“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.”
Currently, Tecentriq holds approvals in the US, the EU and several countries across the world, either as monotherapy or along with targeted treatments and/or chemotherapies in various cancer types.
In March, Roche announced plans to voluntarily withdraw the US indication for Tecentriq in prior platinum treated metastatic urothelial carcinoma, following its consultation with FDA.