Lorviqua

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 was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK tyrosine kinase inhibitor. In this study Lorviqua was not compared with any other treatment or placebo (a dummy treatment).

Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer. Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to the medicine.

Out of patients who had been previously treated with crizotinib and another ALK tyrosine kinase inhibitor, around 40% had a complete or partial response to the medicine.

Lorviqua was also effective when the cancer had spread to the brain. Depending on which previous treatment the patients had received, around 67% and 52% of patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced.

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), oedema (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. For the full list of side effects and restrictions with Lorviqua, see the package leaflet.

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.

Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib. In addition, the company will provide the results of an ongoing study comparing Lorviqua with crizotinib in patients with ALK-positive NSCLC who have not been treated before.

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.