Tuesday, Nov 10, 2015
South San Francisco, CA -- November 10, 2015 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Cotellic™ (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf ® (vemurafenib). Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cotellic is Genentech’s seventh new medicine approved by the FDA in the past five years.
“When used in combination, Cotellic and Zelboraf help delay disease progression and help people live significantly longer than with Zelboraf alone,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With this approval, people with this type of deadly and aggressive skin cancer now have a new targeted option.”
Today’s FDA approval is based on results from the Phase III coBRIM study, which showed Cotellic plus Zelboraf reduced the risk of disease worsening or death (progression-free survival; PFS) by about half in people who received the combination (HR=0.56, 95 percent CI 0.45-0.70; p<0.001), with a median PFS of 12.3 months for Cotellic plus Zelboraf compared to 7.2 months with Zelboraf alone. An interim analysis also showed the combination of Cotellic and Zelboraf helped people live significantly longer (overall survival) than Zelboraf alone (HR=0.63, 95 percent CI 0.47-0.85; p=0.0019). The objective response rate (tumor shrinkage) was higher with Cotellic plus Zelboraf compared to Zelboraf alone (70 vs. 50 percent; p<0.001), as was the complete response rate (complete tumor shrinkage, 16 vs. 10 percent).
Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cotellic can also cause changes in blood test results.
The final overall survival analysis from the coBRIM study will be presented at the Society for Melanoma Research (SMR) 2015 International Congress held in San Francisco, California from November 18-21.
In September, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a positive opinion for Roche’s marketing authorization application for Cotellic in the European Union. A decision from the European Commission is expected before the end of 2015. Cotellic was approved in Switzerland by Swissmedic in August 2015.
Cotellic will be available to people in the United States within two weeks. For those who qualify, Genentech plans to offer patient assistance programs for people taking Cotellic in combination with Zelboraf through Genentech Access Solutions. Doctors can contact Genentech Access Solutions at (888) 249-4918. More information is also available at http://www.Genentech-Access.com.
About the coBRIM study
CoBRIM is an international, randomized, double-blind, placebo-controlled Phase III study evaluating the safety and efficacy of 60 mg once daily of Cotellic plus 960 mg twice daily of Zelboraf compared to 960 mg twice daily of Zelboraf plus placebo. In the study, 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas® 4800 BRAF Mutation Test) and previously untreated for advanced disease were randomized to receive Zelboraf every day on a 28-day cycle plus either Cotellic or placebo on days 1-21. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Investigator-assessed PFS is the primary endpoint. Secondary endpoints include PFS by independent review committee, overall response rate, objective survival, duration of response and other safety, pharmacokinetic and quality of life measures.
About Cotellic plus Zelboraf
Cotellic and Zelboraf are prescription medicines used in combination to treat melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene. Found in approximately half of melanomas, mutated BRAF causes abnormal signaling inside cancer cells leading to tumor growth. Zelboraf is designed to inhibit some mutated forms of BRAF and Cotellic is designed to inhibit some forms of MEK. Both BRAF and MEK are proteins in a cell signaling pathway that help control cell growth and survival. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth longer than with Zelboraf alone. A patient’s healthcare provider will perform a test to make sure Cotellic and Zelboraf are right for the patient. It is not known if Cotellic and Zelboraf are safe and effective in children under 18 years of age.
About advanced melanoma
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. When melanoma is diagnosed early, it is generally a curable disease, but most people with advanced melanoma have a poor prognosis. The American Cancer Society estimates there will be nearly 74,000 new cases of melanoma and 10,000 melanoma deaths this year in the United States.
In recent years, there have been significant advances in treatment for advanced melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.
Cotellic is a prescription medicine used with Zelboraf for the treatment of patients with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene. Cotellic is not used to treat melanoma with a normal BRAF gene. Cotellic was discovered by Exelixis Inc. and was developed by Genentech in collaboration with Exelixis. Cotellic is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumor types such as non-small cell lung cancer and colorectal cancer.
Zelboraf was the first prescription treatment for patients with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene as detected by an FDA-approved test. Cotellic and Zelboraf are not used to treat melanoma with a normal BRAF gene. Zelboraf is now approved in more than 90 countries and has been used to treat more than 20,000 patients worldwide. Zelboraf was co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, now a member of the Daiichi Sankyo Group.
Cotellic Important Safety Information
Before taking Cotellic, patients should tell their doctor if they:
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements because some types of medicines will make Cotellic more harmful or less effective. Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.
Patients should avoid sunlight while taking Cotellic. Cotellic can make patients skin sensitive to sunlight and cause them to burn more easily and get severe sunburns. To help protect against sunburn:
Cotellic may cause serious side effects, including:
Patients must check their skin and tell their doctor right away about any skin changes, including:
A patient’s healthcare provider should check their skin before they start taking Cotellic and every two months while taking Cotellic. A patient’s healthcare provider may continue to check their skin for six months after they stop taking Cotellic.
Some of these eye problems may be a result of something called “serous retinopathy” (a build-up of fluid under the retina of the eye). A patient’s healthcare provider should check their eyes if they notice any of the symptoms above.
The most common side effects of Cotellic include:
A patient’s healthcare provider will take blood tests while they are taking Cotellic. The most common changes to blood tests include:
Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away.
These are not all the possible side effects of Cotellic. For more information about side effects, patients should ask their healthcare provider or pharmacist.
Patients should talk to their doctor for medical advice about side effects. Report side effects to FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please see accompanying full Cotellic Prescribing Information and Patient Information for additional important safety information.
Zelboraf Important Safety Information
Zelboraf can cause serious side effects, including risk of cancers. Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take Zelboraf. Zelboraf may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Patients must talk with their healthcare provider about their risk for these cancers.
Patients must check their skin and tell their doctor right away about any skin changes, including:
A patient’s doctor should check their skin before the patient starts taking Zelboraf, and every two months while the patient is taking Zelboraf, to look for any new skin cancers. Their doctor may continue to check the patient’s skin for six months after the patient stops taking Zelboraf.
A patient’s doctor should also check for cancers that may not occur on the skin. Patients should tell their doctor about any new symptoms they get while taking Zelboraf.
Before taking Zelboraf, patients should tell their doctor if they:
Patients should tell their doctor about all of the medicines they take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Patients should avoid sunlight while they are taking Zelboraf. Zelboraf can make a patient’s skin sensitive to sunlight. Patients may burn more easily and get severe sunburns. To help protect against sunburn:
Possible Side Effects of Zelboraf
The most common side effects include:
Patients should tell their doctor if they have any side effect that bothers them or does not go away. These are not all of the possible side effects of Zelboraf. For more information about side effects, patients should ask their doctor or pharmacist.
Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of 350 in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.
About Genentech in skin cancer
Genentech has been studying new treatments for skin cancer for nearly 20 years. In the last five years, we have brought three new medicines to people with potentially disfiguring or deadly skin cancers. Genentech is continuing to study our skin cancer medicines as monotherapies and in combination with other investigational medicines, such as cancer immunotherapies, in several cancer types and diseases.
Founded more than 35 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.