Alecensa
Oncology· 1384 cited findings· 4 source documents
Company: Roche Holding AG →
What the regulatory reviews say
Alecensa is indicated for the 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. The marketing authorization application was submitted on 8 September 2015, with a Type II variation application submitted on 24 November 2023. The CHMP Opinion date was 25 April 2024.
In a randomized, controlled trial involving 257 patients (130 in the alectinib arm and 127 in the chemotherapy arm), Alecensa demonstrated significant efficacy. The stratified hazard ratio for DFS (alectinib vs chemotherapy, Stage II-IIIA) was 0.24 (p-value < 0.0001). The 24-month event-free rate for the alectinib arm (Stage II-IIIA) was 93.8%, compared to 63.0% for the chemotherapy arm. The median DFS for the chemotherapy arm (Stage II-IIIA) was 44.4 months, while the median DFS for the alectinib arm was not reached.
Regarding safety, 6% of patients experienced AEs leading to withdrawal of treatment. The median duration of treatment was 23.9 months. Serious adverse events (SAE) occurred in 13.3% of patients, with 0.8% leading to treatment discontinuation due to SAE. Deaths were reported in 1.6% of patients.
Key figures — cited to the source page
| Stratified HR for DFS (alectinib vs chemotherapy, Stage II-IIIA) | 0.24 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.37 |
| p-value for DFS (alectinib vs chemotherapy, Stage II-IIIA) | < 0.0001 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.37 |
| 24 Month event free rate (alectinib arm, Stage II-IIIA) | 93.8 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.37 |
| 24 Month event free rate (chemotherapy arm, Stage II-IIIA) | 63.0 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.37 |
| Median DFS (chemotherapy arm, Stage II-IIIA) | 44.4 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.37 |
| AEs leading to withdrawal of treatment | 6 | Roche Holding AG — Alecensa EMA EPAR public assessment repor, p.98 |
| Patients with at least one SAE | 13.3 | HOFFMANN-LA ROCHE — Alecensa FDA Review (NDA/BLA 208434, 202, p.75 |
| CHMP Opinion date | 25 April 2024 | Roche Holding AG — Alecensa EMA EPAR variation assessment re, p.7 |
Source documents
- HOFFMANN-LA ROCHE — Alecensa FDA Review (NDA/BLA 208434, 2024) (2024)
- Roche Holding AG — Alecensa EMA EPAR public assessment report (EMEA/H/C/004164, 2017) (2017)
- Roche Holding AG — Alecensa EMA EPAR variation assessment report (EMEA/H/C/004164, 2017) (2017)
- HOFFMANN-LA ROCHE — Alecensa FDA Summary Review (NDA/BLA 208434, 2016) (2016)
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.