FDA approves Tecentriq + chemo for ES-SCLC

March 25, 2019—Genentech announced FDA approval of Tecentriq (atezolizumab) in combination with carboplatin and etoposide for the initial treatment of adults with extensive-stage small cell lung cancer.

“Extensive-stage small cell lung cancer is a highly aggressive form of lung cancer, which until now has seen limited treatment advances over the last 20 years,” Andrea Ferris, president and CEO of Lungevity Foundation, said in a press release from Genentech. “Today’s approval of Tecentriq is an important step forward in ensuring that people across the spectrum of lung cancer types have effective new therapies.”

Approval is based on results from the phase three IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival=12.3 versus 10.3 months; hazard ratio=0.70, 95 percent CI: 0.54–0.91; p=0.0069) in the intention-to-treat population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95 percent CI: 0.62–0.96; p=0.017).