Tagrisso - Osimertinib

What is Tagrisso and what is it used for - Osimertinib?

Tagrisso is a cancer medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

Tagrisso is indicated in patients with advanced or widespread cancer presenting the T790M mutation, a specific modification of a protein gene called epidermal growth factor receptor (EGFR).

It contains the active substance osimertinib.

How is Tagrisso - Osimertinib used?

Treatment with Tagrisso should be started and supervised by a doctor experienced in the use of anticancer medicines. Before starting treatment, doctors must verify that patients have the T790 mutation. The verification is carried out by genetic analysis performed in an appropriate laboratory.

Tagrisso is available in tablet form (40 and 80 mg). The recommended dose is 80 mg once a day. Treatment with Tagrisso may continue until the disease improves or remains stable and side effects are tolerable. If certain side effects occur, your doctor may decide to reduce the dose or stop treatment.

For more information, see the summary of product characteristics (included with EPAR).

How does Tagrisso - Osimertinib work?

The active substance in Tagrisso, osimertinib, is a type of anticancer medicine called tyrosine kinase inhibitor. It blocks EGFR activity that normally regulates cell growth and division. In lung cancer cells, EGFR is often hyperactive and causes uncontrolled division of cancer cells. By blocking EGFR, osimertinib helps reduce tumor growth and spread.

Unlike most tyrosine kinase inhibitors, Tagrisso acts on tumor cells that exhibit the T790M mutation of the EGFR gene.

What benefits of Tagrisso - Osimertinib have been shown in studies?

Tagrisso has been studied in two main studies involving 411 patients with a T790M mutation, in which the disease progressed despite previous treatment with tyrosine kinase inhibitors (EGFR). In both studies, which were still ongoing at the time of the initial evaluation of Tagrisso, the medicine was not compared with other therapies. The main efficacy parameter was the percentage of patients who responded to treatment (objective response rate) and had a tumor reduction, assessed by body scans and standardized criteria for solid tumors. Combining the two studies, the target response rate at the time of the analysis was 66% (263 of 398 patients) and preliminary data suggested that the mean duration of the response was 8.5 months.

What are the risks associated with Tagrisso - Osimertinib?

The most common side effects with Tagrisso (affecting more than one in 10 people) are diarrhea, rash, dry skin, paronychia (infection of the nail bed), itching, stomatitis (inflammation of the tissue covering the mouth) and reduction in levels of white blood cells and platelets. It must not be given in combination with products containing St. John's wort (a plant preparation used in the treatment of depression). For the full list of restrictions and side effects reported with Tagrisso, see the package leaflet.

Why was Tagrisso - Osimertinib approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tagrisso's benefits are greater than its risks and recommended that it be approved for use in the EU.

Patients with the T790M mutation currently have a poor diagnosis and existing treatment options are very limited; therefore, there is an unmet medical need. Currently available trials have shown promising results with regards to Tagrisso's ability to reduce tumor size. Although Tagrisso has only been tested in patients with the T790M mutation previously treated with tyrosine kinase inhibitors (EGFR), it is expected to be effective even in patients with the T790M mutation not previously treated with these medicines. Regarding safety, the adverse reactions detected with Tagrisso are similar to those of other medicines belonging to the same class and are considered acceptable.

Tagrisso has obtained a "conditional approval". This means that further information on the medicine, which the company is required to provide, will be available in the future. Every year the European Medicines Agency will review any new information that may be available and this summary will be updated as necessary.

What information is still awaited for Tagrisso?

Since Tagrisso has obtained a conditional approval, the company that markets this medicine will make available the results of a study that compares Tagrisso with platinum-based chemotherapy (standard treatment for NSCLC).

What measures are being taken to ensure the safe and effective use of Tagrisso - Osimertinib?

A risk management plan has been developed to ensure that Tagrisso 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 Tagrisso, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.