What is Cotellic - Cobimetinib and what is it used for?
Cotellic is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery. Cotellic is used in combination with another medicine called vemurafenib and is only intended for patients whose melanoma cells have shown a particular mutation (variation) in the BRAF gene called 'BRAF V600'.
Cotellic contains the active substance cobimetinib.
How is Cotellic used - Cobimetinib?
Treatment with Cotellic should be started and supervised by a doctor who has experience in the use of anticancer medicines. Before starting treatment, the BRCA V600 mutation must be checked for the presence of the BRCA V600 mutation. The medicine can only be obtained with a prescription.
Cotellic is available as tablets (20 mg). The recommended dose is 60 mg per day (3 tablets of 20 mg). Cotellic is given in 28-day cycles, where the tablets are taken for 21 consecutive days, followed by a 7-day suspension. If the patient reports certain side effects, the doctor may decide to interrupt or stop the treatment, or to reduce the dose. Treatment should be continued until the patient shows signs of improvement or the disease stabilizes and the patient is able to tolerate the side effects.
For more information, see the summary of product characteristics.
How does Cotellic - Cobimetinib work?
The active substance in Cotellic, cobimetinib, is an inhibitor of MEK, a protein that participates in the stimulation of normal cell division. In melanomas with the BRAF V600 mutation, there is an abnormal form of the BRAF protein, which activates the MEK protein. The resulting uncontrolled division of cells promotes tumor development.
Cotellic works by directly blocking MEK and preventing its activation by the abnormal form of the BRAF protein, thereby slowing the growth and spread of the tumor. Cotellic is only given to patients whose melanoma is caused by the BRAF V600 mutation and must be used in combination with vemurafenib, which is a BRAF inhibitor.
What benefit has Cotellic - Cobimetinib shown during the studies?
Cotellic was investigated in a main study involving 495 patients with melanoma, containing the BRAF V600 mutation, which had spread to other parts of the body or could not be removed by surgery. The patients had not previously undergone. no therapy and were treated with Cotellic and vemurafenib or with placebo (a dummy treatment) and vemurafenib, the main measure of effectiveness being the length of time before the disease got worse (progression-free survival). In this study, the combination of Cotellic and vemurafenib was more effective than the combination of placebo and vemurafenib: the period before the disease got worse was on average 12.3 months among patients treated with Cotellic compared to 7.2 months recorded. among patients treated with placebo.
What is the risk associated with Cotellic - Cobimetinib?
The most common side effects with Cotellic (which may affect more than 1 in 5 people) are diarrhea, rash, nausea, vomiting, pyrexia (fever), photosensitivity reactions (sensitivity to light), abnormal liver function test results ( increased levels of alanine aminotransferase and aspartate aminotransferase) and abnormal findings related to an enzyme associated with muscle breakdown (creatine phosphokinase).
For the full list of restrictions and side effects reported with Cotellic, see the package leaflet.
Why has Cotellic - Cobimetinib been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cotellic's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee noted that Cotellic, used in combination with vemurafenib had demonstrated clinically relevant benefit in patients whose melanoma had the BRAF V600 mutation compared to vemurafenib monotherapy. Since Cotellic and vemurafenib work by blocking several proteins important for tumor growth, their combination induces a more adequate response and may slow the development of tumor cell resistance to vemurafenib. Although a supportive study showed that patients not previously treated with BRAF or MEK inhibitors (such as vemurafenib) appeared to benefit most from therapy, the Committee was of the opinion that subjects previously treated with BRAF inhibitors may still benefit from trat tamento with Cotellic and vemurafenib. Regarding safety, side effects were considered acceptable and manageable with appropriate measures.
What measures are being taken to ensure the safe and effective use of Cotellic - Cobimetinib?
A risk management plan has been developed to ensure that Cotellic is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Cotellic, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information about Cotellic - Cobimetinib
For more information about Cotellic therapy, read the package leaflet (also included with the EPAR) or contact your doctor or pharmacist.
The information on Cotellic - Cobimetinib published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
