Roche Holding AG — Alecensa EMA EPAR public assessment report (EMEA/H/C/004164, 2017)
Roche Holding AG · 2017 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of Alecensa (alectinib) for marketing authorization in ALK-positive NSCLC patients previously treated with crizotinib. It details the drug's quality, manufacturing, and non-clinical profile, including its potent and selective inhibition of ALK and RET kinases, antiproliferative effects, and anti-tumor activity in various models, including against crizotinib-resistant mutations and in CNS models. Pharmacokinetic studies in animals and humans revealed high plasma protein binding, primary faecal excretion, and identified target organs for toxicity. Clinical efficacy was demonstrated in Phase I/II studies (NP28761 and NP28673), showing favorable objective response rates, duration of response, and progression-free survival in the target patient population. The report also covers drug-drug interactions and the impact of food and organ impairment on alectinib's pharmacokinetics.
Key findings — cited to the page
| NOECreproduction (Toxicity to Terrestrial Springtails (Collembola)) | 316 mg/kg dry weight | · p.36 |
| NOEC (Daphnia sp. Reproduction Test) | 0.133 mg/L | · p.35 |
| DLT: Grade 3 neutrophil count decreased | 1 patient | NP28761 · p.58 |
| DLT: Grade 3 headache | 1 patient | NP28761 · p.58 |
| Lung cancer cases worldwide | 1.8 million cases | Global · p.10 |
| Lung cancer related deaths worldwide | 1.6 million deaths | Global · p.10 |
| Frequency of ALK gene rearrangements in NSCLC | 2 to 7 % | · p.10 |
| Eligibility to centralised procedure agreed date | 26 February 2015 | Alecensa · EU · p.8 |
| Proposed indication | treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib | Alecensa · p.8 |
| Procedure start date | 1 October 2015 | · p.9 |
| AEs leading to withdrawal of treatment | 6 % | Studies NP28761 and NP28673 · p.98 |
| Marketing authorization application submission date | 8 September 2015 | Alecensa · EU · p.8 |
Source: Roche Holding AG ↗ · 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 →