Zelboraf
Oncology· 519 cited findings· 2 source documents
Company: Roche Holding AG
What the regulatory reviews say
Zelboraf (vemurafenib) is a drug indicated for the treatment of specific cancers. Regulatory review documents highlight its efficacy in melanoma, demonstrating a median overall survival of 13.2 months for vemurafenib compared to 9.6 months for dacarbazine (with censoring at crossover), with a p-value of <0.0001. The hazard ratio for overall survival was 0.62. Progression-free survival also showed a p-value of <0.0001.
In terms of safety, 90% of patients receiving vemurafenib experienced at least one adverse event, compared to 19% for dacarbazine. Grade 3 or above adverse events were reported in 50% of vemurafenib patients and 30% of dacarbazine patients. Major protocol deviations were observed in 4.2% of the vemurafenib group and 6.8% of the dacarbazine group.
The Marketing Authorisation application for Zelboraf was submitted on 4 May 2011, with a positive opinion from the CHMP issued on 15 December 2011. The CHMP had agreed to an accelerated assessment on 14 April 2011.
Key figures — cited to the source page
| Overall survival (vemurafenib) | 13.2 months | EMA EPAR, p.55 |
| Overall survival (dacarbazine) | 9.6 months | EMA EPAR, p.55 |
| P-value for OS (with censoring at crossover) | <0.0001 | EMA EPAR, p.55 |
| Hazard ratio for OS (with censoring at crossover) | 0.62 | EMA EPAR, p.55 |
| Patients with at least one AE (vemurafenib) | 90 % | EMA EPAR, p.68 |
| Patients with at least one AE (dacarbazine) | 19 % | EMA EPAR, p.68 |
| Patients with Grade 3 or above AEs (vemurafenib) | 50 % | EMA EPAR, p.70 |
| CHMP positive opinion for Marketing Authorisation | 15 December 2011 | EMA EPAR, p.7 |
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.