Pfizer Inc. — Tukysa EMA EPAR public assessment report (EMEA/H/C/005263, 2021)
Pfizer Inc. · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted marketing authorization for Tukysa (tucatinib) on December 10, 2020, for HER2-positive breast cancer, including brain metastases, after at least two prior anti-HER2 regimens, addressing a significant unmet medical need. Pharmaceutical development, non-clinical pharmacology, and toxicology studies confirmed tucatinib's selective HER2 inhibition and acceptable safety profile, with effects on liver, GI, and reproduction noted at clinically relevant doses. Clinical pharmacology established its absorption, distribution, metabolism, and excretion, justifying the 300 mg BID dose. The pivotal HER2CLIMB study demonstrated significant improvements in progression-free survival, overall survival, and objective response rates with tucatinib plus capecitabine and trastuzumab, both overall and in patients with brain metastases. While increasing treatment-related toxicities like diarrhea and palmar-plantar erythrodysesthesia syndrome, the safety profile was deemed acceptable given the patient population. The CHMP recommended authorization based on a positive benefit-risk balance, with ongoing safety monitoring and a post-authorization efficacy study required.
Key findings — cited to the page
| Grade 3 or higher Aspartate aminotransferase increased (Tuc+Cap+Tra) | 4.7 % | HER2CLIMB · p.107 |
| Grade 3 or higher Alanine aminotransferase increased (Tuc+Cap+Tra) | 5.7 % | HER2CLIMB · p.107 |
| Grade 3 or higher Alanine aminotransferase increased (Pbo+Cap+Tra) | 0.5 % | HER2CLIMB · p.107 |
| Grade 3 or higher Palmar-plantar erythrodysesthesia syndrome (Pbo+Cap+Tra) | 9.1 % | HER2CLIMB · p.107 |
| Grade 3 or higher Fatigue (Tuc+Cap+Tra) | 5.4 % | HER2CLIMB · p.107 |
| Grade 3 or higher Fatigue (Pbo+Cap+Tra) | 4.1 % | HER2CLIMB · p.107 |
| Subjects with Grade ≥3 TEAE (Tuc+Cap+Tra) | 59.2 % | HER2CLIMB · p.105 |
| Grade 3 or higher Diarrhoea (Tuc+Cap+Tra) | 13.1 % | HER2CLIMB · p.107 |
| Subjects with Grade ≥3 TEAE (Pbo+Cap+Tra) | 51.3 % | HER2CLIMB · p.105 |
| Grade 3 or higher Palmar-plantar erythrodysesthesia syndrome (Tuc+Cap+Tra) | 13.9 % | HER2CLIMB · p.107 |
| Grade 3 or higher Diarrhoea (Pbo+Cap+Tra) | 8.6 % | HER2CLIMB · p.107 |
| Grade 3 or higher Aspartate aminotransferase increased (Pbo+Cap+Tra) | 0.5 % | HER2CLIMB · p.107 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →