On Wednesday, August 17, the Food and Drug Administration approved Zelboraf, a drug for BRAF V600E mutation-positive metastatic melanoma. Along with skin cancer drug, FDA approved Companion Diagnostic, a mutation diagnostic test.
“Today’s approval of Zelboraf and the (companion) test is a great example of how companion diagnostics can be developed and used to ensure patients are exposed to highly effective, more personalized therapies in a safe manner,” said Alberto Gutierrez, head of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety.
Zelboraf and its Companion Diagnostic are co-developed by Roche (Genentech unit) and Plexxikon, Daiichi Sankyo Group member. Roche and Daiichii will promote this medicine in United States. Zelboraf will be available within two weeks and will be distributed through specialty pharmacies (mail-order pharmacies).
Zelboraf (vemurafenib) is a targeted medicine for inoperable or metastatic melanoma BRAF V600E mutation-positive.
“As the first personalized medicine approved for the treatment of patients with BRAFV600E mutation-positive melanoma, Zelboraf represents a significant new treatment option for these patients suffering from inoperable or metastatic melanoma. We are grateful for the clinical trial participants, clinical investigators, collaborators and dedicated employees, who have all contributed to this important advancement in cancer treatment,” said K. Peter Hirth, Ph.D., chief executive officer of Plexxikon.
The cobas 4800 BRAF V600 Mutation Test identifies tumors that carry the BRAF V600E mutation. In this way the doctors will know what person with inoperable or metastatic melanoma can be treated with Zelboraf. This personalized drug has no known beneficial effect on other skin cancers, thus it is important to have a diagnostic test before taking Zelboraf pills.
“The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods,” said Paul Brown, head of Roche Molecular Systems.
Studies have shown that Zelboraf increases the survival rate in patients with BRAF V600E mutation-positive melanoma.
According to the American Cancer Society, melanoma, a type of skin cancer, is one of the deadliest cancers, with a five-year survival rate of 15 percent for people with advanced melanoma. It is estimated that BRAF mutations appear in about half of all cases of melanoma and may lead to uncontrolled cell growth.
More information about ongoing Zelboraf studies is available at www.roche-trials.com or www.clinicaltrialsregister.eu (in the EU) or www.clinicaltrials.gov (in the US).
Zelboraf might have side effects. The patients should talk to their doctors about their conditions prior the medication and carefully observe the changes that might appear during the treatment.
“Patients should call their doctor for medical advice about any side effects. Patients or their caregivers are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. They may also report side effects to Genentech at 1-888-835-2555.
Patients should read the Zelboraf full Prescribing Information and Medication Guide for additional important safety information at www.zelboraf.com.”
In March, the FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab), an intravenous medicine for patient with advanced melanoma. Roche and Bristol have agreed to collaborate in order to find out if these two medicines are safe and effective if taken together. Roche submitted drug applications for Zelboraf in the EU, Switzerland, Australia, New Zealand, Brazil, India, Mexico and Canada.