FDA Accepts Supplemental Biologics License Application for Tecentriq Combo in NSCLC

The Food and Drug Administration has accepted Roche’s supplemental biologics license application for Tecentriq (atezolizumab) plus chemotherapy for the frontline treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.
 
BY Kristie L. Kahl
PUBLISHED January 17, 2019
The Food and Drug Administration (FDA) has accepted Roche’s supplemental biologics license application for Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) and carboplatin for the frontline treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations.

The supplemental biologics license application included data from the multicenter, open-label, randomized phase 3 IMpower130 study – designed to evaluate the Tecentriq-based combination compared with chemotherapy alone in 724 chemotherapy-naïve patients with stage 4 non-squamous NSCLC.

The study met its co-primary endpoints of improved overall survival (median, 18.6 months vs. 13.9 months, respectively) and progression-free survival (median, 7 vs. 5.5 months) – or the time until disease progression or worsening – in patients who received the Tecentriq combination compared with chemotherapy.

The safety profile for the combination appeared consistent with previous findings. Grade 3 to 4 treatment-related side effects occurred in 73.2 percent of people receiving Tecentriq plus chemotherapy compared to 60.3 percent of people receiving chemotherapy alone.

“We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” Sandra Horning, M.D., Roche’s chief medical officer and head of global product development, said in a press release. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”

The agency is expected to make a decision by Sept. 2, 2019.
 
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