Date: 2012-02-20
Type of information: Granting of a Market Authorisation in the EU
Product name: Zelboraf®
Compound: vemurafenib
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
- kinase inhibitor. Vemurafenib is a BRAF-inhibitor and it is designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer.
Company: Roche (Switzerland)
Disease: BRAF V600 mutation-positive metastatic melanoma
Latest news:
- • On April 2, 2012, Roche announced that the Federal Office of Public Health (BAG) has granted the skin cancer medicine Zelboraf® positive reimbursement status, adding it to the official list of medicines eligible for reimbursement in Switzerland. Zelboraf® is Switzerland’s first and only personalised melanoma medicine for patients suffering from the most aggressive form of skin cancer.
- • On 15 December 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zelboraf®, 240mg, Film-coated tablet intended for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
The benefits with Zelboraf® are its ability to improve overall survival in melanoma patients that have tumours that are positive for BRAFV600E. The most common side effects are rash, arthralgia, fatigue, photosensitivity reaction, nausea, alopecia and pruritis. A pharmacovigilance plan for Zelboraf® will be implemented as part of the marketing authorisation.
- • On August 17, 2011, FDA approved Zelboraf® (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The FDA also approved the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf® is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma. It is designed to target and inhibit some mutated forms of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer. Zelboraf® should be used only in people whose inoperable or metastatic melanoma carries a BRAF V600E mutation, which can be determined by the FDA-approved cobas BRAF Mutation Test.
Zelboraf® will be available in the United States within two weeks of approval.
- * The submissions are based on results from two positive clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma, as determined by the investigational companion diagnostic test also being developed by Roche. Roche also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic. A Premarket Approval Application for the cobas 4800 BRAF V600 Mutation Test was submitted in the U.S. The test will also will also be registered in Europe.
- In April 2011, Daiichi Sankyo acquired Plexxikon, which discovered and is co-developing vemurafenib with Roche. Daiichi Sankyo will co-promote vemurafenib in the U.S. with Genentech under Plexxikon’s co-promote agreement with Genentech.
Patents:
Submission of marketing authorization application USA : 2011-05-11
Submission of marketing authorization application UE: 2011-05-11
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-08-17
UE authorization: 2012-02-20
Favourable opinion UE: 2011-12-15
Favourable opinion USA:
Orphan status USA: 2010-12-20
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
