- Celgene Snaps Up Merck & Co.’s Giant Complex in New Jersey 6,400 views
- Annual Report: Top 10 Pipelines 3,700 views
- Top 10 Pipelines 3,666 views
- Top 100 Biotechnology Companies Special Report: The Acquisition Game 2,300 views
The Pulse of the Pharmaceutical Industry
– Daiichi Sankyo, Inc. to co-promote cobimetinib in combination with Zelboraf along with Genentech and Exelixis
– New co-promote agreement along with pipeline of innovative oncology compounds demonstrate Daiichi Sankyo’s commitment to oncology
PARSIPPANY, N.J. and BERKELEY, Calif., Nov. 10, 2015 /PRNewswire/ — Daiichi Sankyo, Inc. and Plexxikon Inc., a member of the Daiichi Sankyo Group, today announced the U.S. Food and Drug Administration (FDA) approved cobimetinib, developed by Genentech, a member of the Roche Group, and Exelixis Inc., for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf® (vemurafenib). Cobimetinib and Zelboraf are not used to treat melanoma with a normal BRAF gene. Cobimetinib in combination with Zelboraf will be co-promoted in the United States by Genentech, Daiichi Sankyo, Inc. and Exelixis. Cobimetinib will be available within two weeks.
“We are excited to bring a new dual pathway treatment option to patients with BRAF mutation-positive advanced melanoma,” said Ken Keller, President, U.S. Commercial, Daiichi Sankyo, Inc. “We look forward to strengthening our existing relationship with Genentech with the ultimate goal of benefiting patients with advanced melanoma.”
The FDA approval of cobimetinib is based on results from the Phase III coBRIM study, which showed cobimetinib 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 cobimetinib plus Zelboraf compared to 7.2 months with Zelboraf alone. An interim analysis also showed the combination of cobimetinib 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 cobimetinib 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 cobimetinib 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 cobimetinib include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cobimetinib can also cause changes in blood test results.
“This FDA approval underscores the importance of combining two different targeted medicines to help delay disease progression and help people live longer,” said Gideon Bollag, PhD, Chief Executive Officer of Plexxikon.
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 cobimetinib 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 cobimetinib 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, objective response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures.
About Cobimetinib plus Zelboraf
Cobimetinib 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 cobimetinib 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, cobimetinib 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 cobimetinib and Zelboraf are right for the patient. It is not known if cobimetinib and Zelboraf are safe and effective in children under 18 years of age.
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. Zelboraf is now approved in more than 90 countries and has been used to treat more than 20,000 patients worldwide. Daiichi Sankyo, Inc. currently co-promotes Zelboraf with Genentech in the United States.
Zelboraf was discovered by scientists at Plexxikon in 2005 and co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon. In 2011, Daiichi Sankyo acquired Plexxikon and upon FDA approval of Zelboraf in August 2011, co-promotion rights for Zelboraf were transferred to Daiichi Sankyo, Inc.
Cobimetinib 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. Cobimetinib was discovered by Exelixis Inc. and was developed by Genentech. In April 2015, Genentech and Daiichi Sankyo, Inc. entered into a co-promotion agreement for cobimetinib in combination with Zelboraf.
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,1 but most people with advanced melanoma have a poor prognosis.2 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.1
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.1
Cobimetinib Important Safety Information
Before taking cobimetinib, 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 cobimetinib 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 cobimetinib. Cobimetinib can make patients’ skin sensitive to sunlight and cause them to burn more easily and get severe sunburns. To help protect against sunburn:
Cobimetinib 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 cobimetinib and every two months while taking cobimetinib. A patient’s healthcare provider may continue to check their skin for six months after they stop taking cobimetinib.
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 cobimetinib include:
A patient’s healthcare provider will take blood tests while they are taking cobimetinib. 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 cobimetinib. For more information about side effects, patients should ask their healthcare provider or pharmacist. Patients should call their doctor for medical advice about side effects.
Patients should talk to their doctor for medical advice about side effects. Report side effects to FDA at (800) FDA-1088. Report side effects to Genentech at (888) 835-2555.
Please see accompanying full Cobimetinib 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 www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.
About Daiichi Sankyo Oncology
In addition to co-promoting cobimetinib and Zelboraf with Genentech in the United States, Daiichi Sankyo is focused on the discovery and development of novel oncology agents with the goal of delivering first-in-class and best-in-class treatments that address unmet medical needs. The oncology pipeline of Daiichi Sankyo continues to grow and currently includes both small molecules and monoclonal antibodies with novel targets in both solid and hematological cancers.
Daiichi Sankyo currently has four compounds in phase 3 clinical development in the U.S. each with a unique mechanism of action with three focusing on rare or orphan indications. These investigational compounds include quizartinib, an oral FLT3 inhibitor, for relapsed or refractory FLT3-ITD-positive acute myeloid leukemia (AML); pexidartinib (PLX3397), an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT) being developed with Plexxikon, a member of the Daiichi Sankyo Group; tivantinib, an oral MET inhibitor, for second-line treatment of hepatocellular carcinoma in partnership with ArQule, Inc.; and patritrumab, a HER3 monoclonal antibody, for non-small cell lung cancer.
Plexxikon, a member of the Daiichi Sankyo Group since April 2011, is a leader in the structure-guided discovery and development of novel small molecule pharmaceuticals to treat human disease. The company’s drug Zelboraf® (vemurafenib/PLX4032) was approved by the FDA in 2011, and is being co-promoted in the U.S. by Daiichi Sankyo Inc. and Genentech. Plexxikon is developing a portfolio of preclinical and clinical stage compounds to address significant unmet medical needs in oncology and other therapeutic areas. Plexxikon’s Scaffold-Based Drug DiscoveryTM platform integrates multiple state-of-the-art technologies, including structural screening as a key component that provides a significant advantage over other drug discovery approaches.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group’s research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit www.dsi.com.
 American Cancer Society. Melanoma Skin Cancer. 2015.
 Finn L, et al. Therapy for metastatic melanoma: the past, present, and future. BMC Med. 2012;10:23.
SOURCE Daiichi Sankyo, Inc.
PR Newswire source:
Sorry. No data so far.