NICE recommends lung cancer treatment, Lorviqua®q (lorlatinib), at first line, in final draft guidance

Pfizer Ltd announced today that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Lorviqua^®q (lorlatinib) as an option for anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have not had an ALK inhibitor.^[i]

While lorlatinib is already available on the NHS in England in the second-line setting,^[ii] today’s decision means the medicine can now be used as a first-line treatment as well.

Lung cancer is the number one cause of cancer-related death around the world,^[iii] and around 40,008 people are diagnosed with lung cancer in England each year.^[iv]

NSCLC accounts for approximately 80 to 85 per cent of lung cancers,^[v] with ALK-positive tumours occurring in about five per cent.^[vi]

Most people with ALK-positive advanced NSCLC develop brain metastases within five years of diagnosis.^[vii]

Designated by the Medicines and Healthcare products Regulatory Agency (MHRA) as a Promising Innovative Medicine in 2018^[viii] and licensed in 2019,^[ix] lorlatinib was accepted for use as a first-line treatment by the Scottish Medicines Consortium (SMC) within NHS Scotland in 2022.^[x]

Today’s recommendation comes six years after regulatory approval^ix and two years after NICE first decided not to recommend lorlatinib in the first-line setting.^[xi]

Lorlatinib is a third-generation ALK inhibitor and is used to treat people with advanced NSCLC.^ix Administered once daily as an oral treatment,^ix lorlatinib inhibits key enzymes in cells that are involved in the regulation of cell growth and multiplication.

By inhibiting these key components, lorlatinib can inhibit the growth and even kill cancer cells in some patients.^ix It was specifically designed to cross the blood-brain barrier and prevent the development of ALK resistant mutations.^[xii]

Yvonne Diaz, Co-founder and Chair, Oncogene Cancer Research: “We are delighted that NICE has recommended lorlatinib as a first-line treatment for ALK-positive advanced non-small-cell lung cancer, which tends to affect younger patients and has a higher symptom burden and a poorer survival prognosis compared with other non-small-cell lung cancers.

“Since there’s currently no cure for the disease, it’s essential that patients are able to access therapies that can help them have a good quality of life and live progression-free for years.”

Dr Shobhit Baijal, Consultant Medical Oncologist based at The University Hospital Birmingham NHS Trust, said: “Although ALK-positive advanced NSCLC is a relatively rare form of lung cancer, it often presents in an advanced stage and carries a high risk of spread to the brain resulting in devastating consequences for patients.

“Today’s decision from NICE is very welcome as lorlatinib has the potential to change the treatment landscape by giving healthcare professionals the opportunity to administer a therapy that not only effectively targets and inhibits the growth of ALK-positive tumours but also reduces the risk of disease progression in the brain in a first-line setting.”

Colm Doody, Oncology Medical Director, Pfizer UK, said: “We are really pleased with the NICE guidance for lorlatinib, which now aligns with advice accepted by the Scottish Medicines Consortium in 2022 and the marketing authorisation indication granted in 2019.

“Moving forwards, eligible patients will be able to receive the treatment earlier in the pathway and at a time when it is likely to have most effect.”