Novartis AG — Tafinlar EMA EPAR public assessment report (EMEA/H/C/002604, 2013)
Novartis AG · 2013 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Tafinlar (dabrafenib) for unresectable or metastatic melanoma with a BRAF V600 mutation is detailed. The report covers the regulatory process, product characteristics, and scientific discussions. Quality aspects, including formulation and manufacturing, were deemed satisfactory. Preclinical studies confirmed dabrafenib's selective inhibition of BRAF mutant kinases, leading to reduced cell proliferation, but also identified dose-dependent toxicities like reproductive and phototoxicity. Environmental risk was assessed, and non-clinical studies supported marketing authorization. Clinical trials, particularly the BREAK-3 study, demonstrated significant improvement in progression-free survival compared to DTIC at a recommended dose of 150 mg BID. While safety concerns like cutaneous squamous cell carcinoma exist, they are manageable. The CHMP recommended granting marketing authorization due to a positive benefit-risk balance.
Key findings — cited to the page
| Grade 5 SAEs | 5 | · p.93 |
| Photo irritation factor (PIF) value for dabrafenib | >83 | · p.30 |
| NOEC (Daphnia sp. Reproduction Test) | 0.105 mg/L | · p.32 |
| overall survival hazard ratio | 0.76 | BREAK-3 · p.92 |
| Eligibility to centralised procedure agreed date | 23 June 2011 | Tafinlar · Europe · p.6 |
| Marketing Authorisation in USA date | 29 May 2013 | Tafinlar · United States · p.7 |
| Marketing Authorisation application submission date | 24 July 2012 | Tafinlar · Europe · p.6 |
| median duration of response for DTIC (June 2012 data) | 7.6 months | BREAK-3 · p.57 |
| median progression-free survival (months) | 6.9 months | BREAK-3 · p.92 |
| median progression-free survival (months) | 2.7 months | BREAK-3 · p.92 |
| progression-free survival hazard ratio | 0.37 | BREAK-3 · p.92 |
| CHMP positive opinion date | 27 June 2013 | Tafinlar · Europe · p.7 |
Source: Novartis 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 →