AstraZeneca PLC — Truqap EMA EPAR public assessment report (EMEA/H/C/006017, 2024)
AstraZeneca PLC · 2024 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Truqap (capivasertib) for HR-positive, HER2-negative, locally advanced or metastatic breast cancer with specific genetic alterations, in combination with fulvestrant, resulted in a positive CHMP opinion. The report details the drug's quality, non-clinical pharmacology, pharmacokinetics (absorption, distribution, metabolism, excretion, drug interactions), and toxicology, including dose-dependent adverse effects and genotoxic potential. Clinical trials, particularly CAPItello-291, demonstrated significant improvements in progression-free survival and overall response rates, especially in altered patient populations. While efficacy was notable, the safety profile showed higher rates of adverse events like diarrhea, rash, and hyperglycemia, requiring risk management. Despite these, the benefit-risk balance was deemed positive, supporting marketing authorization.
Key findings — cited to the page
| Diarrhoea CTCAE Grade 3 or higher (CAPItello-291, capivasertib + fulvestrant) | 9.3 % | CAPItello-291 · p.146 |
| Rash CTCAE Grade 3 or higher (CAPItello-291, capivasertib + fulvestrant) | 5.4 % | CAPItello-291 · p.146 |
| Patients with any CTCAE ≥ Grade 3 AE (CAPItello-291, capivasertib + fulvestrant) | 42.8 % | CAPItello-291 · p.146 |
| Patients with any CTCAE ≥ Grade 3 AE (Combined Pool, capivasertib + fulvestrant) | 44.7 % | Combined Pool · p.146 |
| Rash maculo-papular CTCAE Grade 3 or higher (CAPItello-291, capivasertib + fulvestrant) | 6.2 % | CAPItello-291 · p.146 |
| Rash maculo-papular CTCAE Grade 3 or higher (CAPItello-291, placebo + fulvestrant) | 0 % | CAPItello-291 · p.146 |
| Any AE of CTCAE Grade 3 or higher (capivasertib + fulvestrant) | 42.8 % | CAPItello-291 · p.144 |
| Any AE of CTCAE Grade 3 or higher (placebo + fulvestrant) | 15.7 % | CAPItello-291 · p.144 |
| Patients with any CTCAE ≥ Grade 3 AE (CAPItello-291, placebo + fulvestrant) | 15.7 % | CAPItello-291 · p.146 |
| Patients with any CTCAE ≥ Grade 3 AE (FTIH Study Pool, capivasertib + fulvestrant) | 53.3 % | FTIH Study Pool · p.146 |
| Diarrhoea CTCAE Grade 3 or higher (CAPItello-291, placebo + fulvestrant) | 0.3 % | CAPItello-291 · p.146 |
| Rash CTCAE Grade 3 or higher (CAPItello-291, placebo + fulvestrant) | 0.3 % | CAPItello-291 · p.146 |
Source: AstraZeneca PLC ↗ · 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 →