Wednesday, 26 June 2019

Roche’s new initial treatment option gets FDA nod to treat ES-SCLC

19 March 2019 | News

Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)

Roche announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone  in the intention-to-treat (ITT) population.

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.

“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 Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “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 have been shown to improve survival compared to chemotherapy.

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