December 16, 2011 — The European Medicines Agency has recommended the approval of vemurafenib (Zelboraf, Plexxikon/Roche), a first-in-class treatment for metastatic or unresectable melanoma.
In its assessment for the European Medicines Agency, the Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for the product.
Vemurafenib is a novel protein-kinase inhibitor used in the treatment of melanomas with BRAF V600 mutations. An estimated 50% of patients with melanoma have this type of BRAF mutation, which does not occur in normal cells. The drug is not indicated for use in patients without the mutation.
The US Food and Drug Administration approved the oral targeted therapy in August of this year.
In a recently presented phase 3 trial, vemurafenib improved progression-free and overall survival, compared with standard chemotherapy, in patients with advanced melanoma and no previous treatment.
Patients receiving vemurafenib had a 74% reduction in the risk for progression (or death), compared with patients receiving dacarbazine chemotherapy (hazard ratio, 0.26; P < .001). Mean progression-free survival was 5.3 months in the vemurafenib group and 1.6 months in the dacarbazine group.
The progression-free survival data constitute "an unprecedented level of difference," said lead author Paul Chapman, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, who presented the data at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year, as reported by Medscape Medical News.
At 6 months, estimated overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. No median overall survival was reported because the data are not mature enough, Dr. Chapman explained at the ASCO meeting. The results of the study were published in June in the New England Journal of Medicine.
In that interim analysis, the median follow-up of the overall survival data was 3.8 months in the vemurafenib group and 2.3 months in the dacarbazine group.
In its assessment, the Committee for Medicinal Products for Human Use looked at adverse events associated with vemurafenib.
The committee evaluated secondary neoplasms, most notably squamous cell carcinoma of the skin, and decided the magnitude of the risk was likely to be low, according to a press statement. The committee also said that squamous cell carcinoma can be managed with routine monitoring during treatment.
A recent study on the risk for secondary cancers with the new drug concluded that clinicians should not use vemurafenib in patients with earlier-stage melanomas because of possible second cancers. However, squamous cell carcinoma was not the outstanding concern; instead, possible second cancers of the lung, pancreas, and other sites were highlighted. The concerns are theoretical at this point, and based on evidence that vemurafenib and other RAF inhibitors might promote the "hyperproliferation of preexistent dormant RAS mutant cancer cells."
In its assessment for the European Medicines Agency, the Committee for Medicinal Products for Human Use recommended the granting of a marketing authorization for the product.
Vemurafenib is a novel protein-kinase inhibitor used in the treatment of melanomas with BRAF V600 mutations. An estimated 50% of patients with melanoma have this type of BRAF mutation, which does not occur in normal cells. The drug is not indicated for use in patients without the mutation.
The US Food and Drug Administration approved the oral targeted therapy in August of this year.
In a recently presented phase 3 trial, vemurafenib improved progression-free and overall survival, compared with standard chemotherapy, in patients with advanced melanoma and no previous treatment.
Patients receiving vemurafenib had a 74% reduction in the risk for progression (or death), compared with patients receiving dacarbazine chemotherapy (hazard ratio, 0.26; P < .001). Mean progression-free survival was 5.3 months in the vemurafenib group and 1.6 months in the dacarbazine group.
The progression-free survival data constitute "an unprecedented level of difference," said lead author Paul Chapman, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, who presented the data at the American Society of Clinical Oncology (ASCO) annual meeting earlier this year, as reported by Medscape Medical News.
At 6 months, estimated overall survival was 84% (95% confidence interval [CI], 78 to 89) in the vemurafenib group and 64% (95% CI, 56 to 73) in the dacarbazine group. No median overall survival was reported because the data are not mature enough, Dr. Chapman explained at the ASCO meeting. The results of the study were published in June in the New England Journal of Medicine.
In that interim analysis, the median follow-up of the overall survival data was 3.8 months in the vemurafenib group and 2.3 months in the dacarbazine group.
In its assessment, the Committee for Medicinal Products for Human Use looked at adverse events associated with vemurafenib.
The committee evaluated secondary neoplasms, most notably squamous cell carcinoma of the skin, and decided the magnitude of the risk was likely to be low, according to a press statement. The committee also said that squamous cell carcinoma can be managed with routine monitoring during treatment.
A recent study on the risk for secondary cancers with the new drug concluded that clinicians should not use vemurafenib in patients with earlier-stage melanomas because of possible second cancers. However, squamous cell carcinoma was not the outstanding concern; instead, possible second cancers of the lung, pancreas, and other sites were highlighted. The concerns are theoretical at this point, and based on evidence that vemurafenib and other RAF inhibitors might promote the "hyperproliferation of preexistent dormant RAS mutant cancer cells."
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