Nexavar

Oncology· 434 cited findings· 1 source document

Company: Bayer Aktiengesellschaft

What the regulatory reviews say

Nexavar (sorafenib) is a drug for which a variation to the therapeutic indication was assessed. Sorafenib demonstrates efficacy through inhibition of RET receptor (7-50 nM), RET signalling and cell proliferation (lower nanomolar range), and BRAF, BRAFV600E and CRAF (6 and 38 nM). In an orthotopic PTC derived TPC-1 tumor model, it achieved a 94% tumor volume reduction. Sorafenib also induced apoptosis in ATC derived cell lines by 40%.

In a pivotal Phase III study (Study 14295) involving 417 patients, with 207 in the sorafenib arm (400 mg BID), the median time to progression (TTP) for sorafenib was 11.1 months compared to 5.8 months for placebo, with a hazard ratio of 0.557 (p-value <0.0001). The response rate (RR) for sorafenib was 12.2% versus 0.5% for placebo, showing a difference of 11.8% (p-value <0.0001). Notable safety findings include elevation of ALT in 58.9% of patients. In terms of patient-reported side effects, 30% of patients were bothered by side effects at cycle 2, decreasing to 15% by cycle 6, while 55% were not at all or a little bit bothered by side effects at cycle 6.

Nexavar received orphan medicinal product designation on multiple dates, including 29 July 2004, 11 April 2006, and 13 November 2013. The regulatory procedure number for this variation was EMEA/H/C/000690/II/0035.

Key figures — cited to the source page

median TTP for sorafenib	11.1	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.30
median TTP for placebo	5.8	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.30
HR for TTP (sorafenib/placebo)	0.557	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.30
RR for sorafenib	12.2	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.30
RR for placebo	0.5	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.30
elevation of ALT	58.9	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.56
patients bothered by side effects (cycle 6)	15	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.42
Orphan medicinal product designation date	29 July 2004	Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assess, p.6

Source documents

Bayer Aktiengesellschaft — Nexavar EMA EPAR variation assessment report (EMEA/H/C/000690, 2006) (2006)

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.