Roche’s Tecentriq combo scores FDA approval in non-small cell lung cancer

pharmafile | December 4, 2019 | News story | Research and Development, Sales and Marketing FDA, NSCLC, Roche, pharma, tecentriq 

Roche’s immunotherapy Tecentriq (atelizumab) has chalked up another approval from the FDA, this time in combination with the chemotherapy Abraxane (paclitaxel protein-bound; nab-paclitaxel and carboplatin) for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumours display no EGFR or ALK genomic aberrations.

Phase 3 data submitted in support of the approval showed that the combo produced a median overall survival benefit of 18.6 months compared to 13.9 months with chemo alone in the intention-to-treat wild-type population; it also improved progression-free survival by 7.2 months as opposed to 6.5 months

The safety profile for the drug was in line with previous data, with 73.2% of users experiencing a grade 3 or 4 treatment-related adverse event, compared to 60.3% with standard chemotherapy alone.

“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” said Dr Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease.”

Matt Fellows

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