GENENTECH INC — Tecentriq FDA Summary Review (NDA/BLA 761041, 2016)
Roche Holding AG · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
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This summary review details the FDA approval of Genentech's Tecentriq (atezolizumab) for metastatic non-small cell lung cancer (NSCLC). The drug received breakthrough therapy designation. Efficacy was demonstrated in the POPLAR and OAK studies, showing improved overall survival compared to docetaxel. Safety findings included immune-related adverse events such as colitis, diarrhea, and thyroid dysfunction, with infection rates also noted. The FDA did not convene an Advisory Committee and granted a pediatric waiver. Tecentriq was approved for its indicated use in metastatic NSCLC.
Key findings — cited to the page
| Pyrexia (Docetaxel, all grades) | 13 % | · p.15 |
| Pneumonia (Docetaxel, all grades) | 4 % | · p.15 |
| Grade 3-4 adverse events | 43 % | · p.4 |
| Pyrexia (TECENTRIQ, all grades) | 18 % | · p.15 |
| Pneumonia (TECENTRIQ, all grades) | 18 % | · p.15 |
| Pneumonia (TECENTRIQ, Grade 3-4) | 6 % | · p.15 |
| Grade 3 hypothyroidism incidence | 3 patients | · p.17 |
| Back pain (TECENTRIQ, all grades) | 14 % | · p.15 |
| Grade 3 colitis or diarrhea incidence | 1.2 % | · p.17 |
| Grade 3-4 adverse events for docetaxel | 55 % | · p.4 |
| Back pain (TECENTRIQ, Grade 3-4) | 1 % | · p.15 |
| Pneumonia (Docetaxel, Grade 3-4) | 2 % | · p.15 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →