Dalafeni Chinese Description

EMA/155658/2017

EMEA/H/C/002604

EPAR summary of the public

Tafinlar

Dabrafenib

this isTafinlarSummary of the European Public Assessment Report (EPAR). It explains how the Agency evaluates drugs to recommend their authorization in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tafinlar.

For practical information on using Tafinlar, patients should read the package insert or contact their doctor or pharmacist.

What is Tafinlar, what is it used for?

Tafinlar is a cancer drug used to treat adults:

Melanoma(A skin cancer) has spread or cannot be removed by surgery. Tafinlar is

Used alone or in combination with trametinib, tramitenib is another cancer drug for the treatment of melanoma;

LateNon-small cell lung cancer. Tafinlar is used in conjunction with tramiteinib.

Tafinlar is only suitable for patients with cancer cells with specific genetic mutations (changes) called "BRAF"

V600'.

Tafinlar contains the active substance dabrafenib.

How is Tafinlar used?

Tafinlar treatment must be initiated and supervised by a physician with experience in the use of cancer medications. This medicine is only available by prescription.

Tafinlar is available as a capsule (50 and 75 mg). The dosage of Tafinlar used alone or in combination with trimetinib was 150 mg twice daily.

Tafinlar is taken at least one hour before the meal or two hours after the meal. As long as the patient benefits, Tafinlar can continue to use. If certain side effects occur, it may be necessary to interrupt or stop treatment, or to reduce the dose. For more information, see the product feature summary (also part of the EPAR).

How does Tafinlar work?

The active substance dabrafenib in Tafinlar acts by blocking BRAF, a protein involved in stimulating cell division. In melanoma and non-small cell lung cancer with BRAF V600 mutations, the abnormal form of BRAF plays a role in the development of cancer by allowing uncontrolled division of tumor cells. By blocking the effects of abnormal BRAF, Tafinlar helps slow the growth and spread of cancer. Tafinlar is only suitable for patients with cancer caused by mutations in the BRAF V600.

Research shows what benefits does Tafinlar have?

Melanoma

In patients with melanoma with a BRAF V600 mutation, Tafinlar is more effective than the cancer drug dacarbazine in controlling melanoma that has spread to other parts of the body or that cannot be surgically removed. This is based on a major study involving 250 patients measuring the patient's longevity before disease progression (no progression survival). In this study, patients given Tafinlar required an average of 6.9 months before the condition worsened, compared with 2.7 months for patients given dacarbazine.

Two other studies focused on the use of Tafinlar and Trametinib. In one study, 423 patients used a combination or Tafinlar alone. Patients given this combination survived for 11 months without disease progression, while patients given Tafinlar alone survived for 8.8 months without disease progression. In a second study involving 704 patients, Tafinlar and trametinib were compared to another melanoma drug, vemurafenib. Give the patient a combination of the combination

The average is 25.6 months, while the use of vemurafenib is 18 months.

Non-small cell lung cancer

In one major study, 171 patients with non-small cell lung cancer with BRAF V600 mutation received Tafinlar combined with trimetinib or Tafinlar alone. The primary measure of effectiveness is the percentage of patients who respond in whole or in part to treatment. The response to treatment is assessed using body scans and clinical data from the patient. The use of Tafinlar and trametinib resulted in more than 60% of patients responding, compared with 23% of patients using Tafinlar alone.

What are the risks of Tafinlar?

The most common side effects of Tafinlar alone (more than 15% of patients) are papilloma (疣), headache, nausea, vomiting, hyperkeratosis (skin thickening and hardening), hair loss, rash, joint pain, fever and fatigue .

When Tafinlar is used in combination with trametinib, the most common side effects (more than 20% of patients) are fever, fatigue, nausea, headache, chills, diarrhea, rash, joint pain, high blood pressure, vomiting and coughing.

For a complete list of all the side effects reported by Tafinlar, please refer to the package insert.

Why is Tafinlar approved?

The agency's Human Drugs Committee (CHMP) determines that Tafinlar's interests outweigh its risks and recommends approval for use in the EU. The committee concluded that Tafinlar (used alone or in combination with trametinib) has significant clinically relevant benefits in patients with BRAF V600 mutations in which the melanoma has spread or has not been surgically removed. Similar benefits were shown when Tafinlar was combined with trametinib for patients with advanced non-small cell lung cancer. Side effects are considered acceptable and controllable through appropriate measures.

What measures are being taken to ensure the safe and effective use of Tafinlar?

The recommendations and precautions that medical professionals and patients should follow to use Tafinlar safely and effectively are included in the product feature summary and package insert.

Additional information about Tafinlar

The European Commission granted an effective listing permit for the entire EU Tafinlar on August 26, 2013.

Tafinlar's complete EPAR can be found on the FDA's website: ema.europa.eu/Find medicine / Human medicine / European public assessment reports. For more information on using Tafinlar treatment, please read the package insert (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated on 03-2017.