Drug

LORVIQUA®

lorlatinib

Lorviqua Overview

Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive’, which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).

Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.

Lorviqua contains the active substance lorlatinib.

Lorviqua can only be obtained with a prescription. Treatment with Lorviqua should be started and supervised by a doctor who is experienced in using cancer medicines. Genetic defects affecting ALK (‘ALK-positive’ status) should be confirmed in advance.

Lorviqua is available as tablets (25 and 100 mg) and the recommended dose is 100 mg once a day. If certain side effects develop the doctor may reduce the dose or interrupt treatment temporarily. Treatment may be stopped altogether if the patient develops severe side effects.

For more information about using Lorviqua, see the package leaflet or contact your doctor or pharmacist.

ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them. In patients with ‘ALK-positive’ NSCLC, an abnormal form of ALK is produced that causes the cancer cells to divide and grow in an uncontrolled fashion.

The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor. It works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer cells.

Lorviqua is effective at treating ALK-positive NSCLC that has worsened despite treatment with other ALK tyrosine kinase inhibitors. Lorviqua was also effective against cancer that had spread to the brain.

Very few other treatments are available for patients after ALK tyrosine kinase inhibitors have failed or for those whose cancer has spread to the brain, and the side effects with Lorviqua are manageable. The European Medicines Agency therefore decided that Lorviqua’s benefits are greater than its risks and it can be authorised for use in the EU.

Lorviqua has been given ‘conditional authorisation’. There is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lorviqua have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lorviqua are continuously monitored. Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.

Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019. 

What are the risks associated with Lorviqua?

The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), \ (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), problems with thinking, learning and memory, tiredness, weight gain and effects on mood.

Lorviqua must not be used together with medicines known as ‘strong CYP3A4/5 inducers’ because the combined medicines could have an effect on the liver. 

Owner of copyright and other intellectual property rights to European Medicines Agency

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