Pfizer Inc. — Tukysa FDA Review (NDA213411, ORIG 1, 2020)
Pfizer Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of tucatinib (TUKYSA) for HER2-positive breast cancer, including patients with brain metastases, recommends regular approval. The HER2CLIMB trial demonstrated significant improvements in progression-free and overall survival when tucatinib was combined with trastuzumab and capecitabine. Nonclinical studies confirmed HER2-specific inhibition but identified potential toxicities in the GI system, liver, and reproductive organs. The safety profile, while manageable, showed increased incidences of diarrhea and elevated liver function tests. Dosage adjustments are recommended for severe hepatic impairment and with strong CYP2C8 inhibitors. No postmarketing requirements were issued.
Key findings — cited to the page
| Epistaxis (all grades) on tucatinib arm | 12 % | HER2CLIMB · p.180 |
| Grade >=3 TEAE (Tuc+Cap+Tra Q2) | 46 (49.5) % | HER2CLIMB · p.89 |
| Dyspnoea (all grades) on tucatinib arm | 12 % | HER2CLIMB · p.180 |
| Dyspnoea (Grade 3-4) on placebo arm | 5 % | HER2CLIMB · p.180 |
| Deaths due to Grade 4 diarrhea | 2 | HER2CLIMB · p.17 |
| Grade >=3 TEAE (Tuc+Cap+Tra Q1) | 62 (66.0) % | HER2CLIMB · p.89 |
| Neutrophil count decreased (Grade 3-4) on tucatinib arm | 2.5 % | HER2CLIMB · p.180 |
| Neutrophil count decreased (Grade 3-4) on placebo arm | 4.6 % | HER2CLIMB · p.180 |
| Dyspnoea (all grades) on placebo arm | 12 % | HER2CLIMB · p.180 |
| Dyspnoea (Grade 3-4) on tucatinib arm | 1.7 % | HER2CLIMB · p.180 |
| Epistaxis (all grades) on placebo arm | 5 % | HER2CLIMB · p.180 |
| Grade >=3 TEAE (Tuc+Cap+Tra Q3) | 50 (53.8) % | HER2CLIMB · p.89 |
Source: Pfizer Inc. ↗ · 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 →