GENENTECH INC — Tecentriq FDA Review (NDA/BLA 761034, 2021)
Roche Holding AG · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Tecentriq (atezolizumab) for various cancer indications, including urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and extensive-stage small cell lung cancer (ES-SCLC). Efficacy data from trials like IMvigor210, IMpower150, OAK, IMpassion130, and IMpower133 demonstrate significant improvements in overall survival, progression-free survival, and objective response rates, often in combination with chemotherapy. The safety profile, including common and immune-mediated adverse reactions, treatment discontinuations, and laboratory abnormalities, is thoroughly reviewed. Regulatory approvals, dosage, administration, warnings, and post-marketing commitments are also outlined.
Key findings — cited to the page
| Grade 3-4 diarrhea or colitis incidence (Tecentriq in combination with platinum-based chemotherapy) | 4.3% | TECENTRIQ · p.17 |
| Grade 3-4 hypothyroidism incidence (Tecentriq in combination with platinum-based chemotherapy) | 0.3% | TECENTRIQ · p.17 |
| Grade 3-4 hepatitis incidence (Tecentriq in combination with platinum-based chemotherapy) | 4.1% | TECENTRIQ · p.17 |
| Grade 3 diarrhea or colitis incidence (single-agent Tecentriq) | 1.4% | TECENTRIQ · p.17 |
| Grade 5 hepatitis incidence (single-agent Tecentriq) | <0.1% | TECENTRIQ · p.16 |
| Grade 4 hepatitis incidence (single-agent Tecentriq) | 0.6% | TECENTRIQ · p.16 |
| Grade 3 pneumonitis incidence (single-agent Tecentriq) | 0.6% | TECENTRIQ · p.16 |
| Grade 3-4 pneumonitis incidence (Tecentriq in combination with platinum-based chemotherapy) | 1.4% | TECENTRIQ · p.16 |
| Grade 5 pneumonitis incidence (single-agent Tecentriq) | <0.1% | TECENTRIQ · p.16 |
| Grade 4 pneumonitis incidence (single-agent Tecentriq) | 0.1% | TECENTRIQ · p.16 |
| Grade 3 hepatitis incidence (single-agent Tecentriq) | 2.3% | TECENTRIQ · p.16 |
| Grade 3 adrenal insufficiency incidence | 0.1 % | · p.18 |
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 →