Cotellic - Cobimetinib

What is Cotellic and what is it used for?

Cotellic is a cancer medicine indicated for the treatment of adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed surgically. Cotellic is used in combination with another medicine called vemurafenib and is only intended for patients in whom the melanoma cells have shown a particular mutation (variation) in the BRAF gene, called "BRAF V600".

Cotellic contains the active substance cobimetinib.

How is Cotellic - Cobimetinib used?

Cotellic treatment should be started and supervised by a doctor experienced in the use of anticancer medicines. Before starting treatment, the presence of the BRCA V600 mutation must be ascertained. The medicine can only be obtained with a prescription.

Cotellic is available as tablets (20 mg). The recommended dose is 60 mg a day (3 tablets of 20 mg). Cotellic is administered in 28-day cycles, in which 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 stop 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 a MEK inhibitor, a protein that stimulates normal cell division. In the BRAF V600 mutation melanomas there is an abnormal form of the BRAF protein, which activates the MEK protein. The consequent uncontrolled division of the cells favors the development of the tumor.

Cotellic acts by blocking the MEK directly and preventing its activation by the abnormal form of the BRAF protein, thereby slowing down the growth and spread of the tumor. Cotellic is only given to patients whose melanoma is caused by the BRAF V600 mutation and should be used in combination with vemurafenib, which is a BRAF inhibitor.

What benefit has Cotellic - Cobimetinib shown during the studies?

Cotellic was examined 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 surgically. Patients had not previously received any therapy and were treated with Cotellic and vemurafenib or with placebo (a dummy treatment) and vemurafenib; the main measure of effectiveness was the period of time elapsed 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 elapsed 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 of Cotellic (which may affect more than 1 in 5 people) are diarrhea, skin erythema, nausea, vomiting, pyrexia (fever), photosensitivity reactions (light sensitivity), abnormal liver function tests ( increased levels of alanine aminotransferase and aspartate aminotransferase) and abnormal results related to an enzyme associated with muscle degradation (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 shown a clinically relevant benefit in patients whose melanoma had the BRAF V600 mutation compared with vemurafenib monotherapy. Because Cotellic and vemurafenib work by blocking several proteins important for tumor growth, their combination induces a more adequate response and could 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) seemed to benefit the most from the therapy, the committee is of the opinion that subjects previously treated with BRAF inhibitors could however take advantage of treatment with Cotellic and vemurafenib. As for 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 included in the summary of product characteristics and the package leaflet for Cotellic, including the appropriate precautions to be followed by healthcare professionals and patients.