Zykadia
Oncology· 1290 cited findings· 2 source documents
Company: Novartis AG →
What the regulatory reviews say
Zykadia (ceritinib) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Its current approved indication in the EU is for patients previously treated with crizotinib. A variation application was submitted on 5 December 2016 to extend this indication to include first-line treatment for ALK-positive advanced NSCLC, receiving a CHMP Opinion on 18 May 2017.
In a Phase III, open-label, randomised, active-controlled global study (CLDK378A2301, ASCEND-4) involving 376 patients, ceritinib demonstrated a median Progression-Free Survival (PFS) of 16 months compared to 8 months for chemotherapy. The PFS Hazard Ratio was 0.55. The Objective Response Rate (ORR) for ceritinib was 72.5%, with a median duration of response of 23.9 months, versus 11 months for chemotherapy. For safety, 925 patients were treated with ceritinib in a pooled dataset, with 76.1% discontinuing treatment and 23.9% ongoing. In Study A2301, 78.3% of ceritinib-treated patients required at least one dose interruption, compared to 44.6% for pemetrexed.
Key figures — cited to the source page
| Median PFS (ceritinib) | 16 months | Novartis AG — Zykadia EMA EPAR variation assessment report, p.59 |
| Median PFS (chemotherapy) | 8 months | Novartis AG — Zykadia EMA EPAR variation assessment report, p.59 |
| PFS HR | 0.55 | Novartis AG — Zykadia EMA EPAR variation assessment report, p.59 |
| ORR (ceritinib) | 72.5 % | Novartis AG — Zykadia EMA EPAR variation assessment report, p.59 |
| Median duration of response (ceritinib) | 23.9 months | Novartis AG — Zykadia EMA EPAR variation assessment report, p.59 |
| Patients discontinued treatment (pooled dataset) | 76.1 % | Novartis AG — Zykadia EMA EPAR variation assessment report, p.62 |
| Patients requiring at least one dose interruption (ceritinib, Study A2301) | 78.3 % | Novartis AG — Zykadia EMA EPAR variation assessment report, p.64 |
| Proposed new indication | first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) | Novartis AG — Zykadia EMA EPAR variation assessment report, p.6 |
Source documents
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.