Roche gets FDA approval for Tecentriq chemotherapy combination
Roche
Fr.239.20
18:55 24/04/24
Roche announced on Tuesday that the US Food and Drug Administration (FDA) has approved ‘Tecentriq’ (atezolizumab), in combination with carboplatin and etoposide chemotherapy, for the initial treatment of adults with extensive-stage small cell lung cancer.
The Swiss pharmaceuticals giant said the approval was based on results from the phase 3 ‘IMpower133’ study, which showed that Tecentriq in combination with chemotherapy helped people live “significantly longer” compared to chemotherapy alone in the intention-to-treat population.
It said the Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone.
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq, Roche claimed.
“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” said Roche chief medical officer and head of global product development, Sandra Horning.
“Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”