Genentech’s Tecentriq has picked up its second regulatory approval this month from the U.S. Food and Drug Administration (FDA). Late Monday the regulatory agency approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the initial treatment of adults with extensive-stage small cell lung cancer.
This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years. The latest approval for Tecentriq, an anti-PDL1 inhibitor, was based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people with this disease live significantly longer compared to chemotherapy alone. That was the first Phase III study to show an immunotherapy-based combination significantly improved overall survival as an initial treatment for people with ES-SCLC, 12.3 months versus 10.3 months. In addition to improving overall survival, Genentech said the combination also improved progression-free survival in the same patients.
Tecentriq is also approved in combination with Avastin, paclitaxel and carboplatin, as a first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq is approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy.