Pfizer Ltd announced that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Lorviqua® (lorlatinib) as an option for adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.
While lorlatinib has already been available on the NHS in England for patients in the second-line setting, this new recommendation expands its use as a first-line treatment option.
Lung cancer remains the leading cause of cancer-related deaths globally, with around 40,000 people diagnosed in England each year. NSCLC accounts for roughly 80–85% of all lung cancers, and ALK-positive tumours represent about 5% of these cases. Notably, the majority of patients with ALK-positive advanced NSCLC develop brain metastases within five years of diagnosis.
Lorlatinib, designated as a Promising Innovative Medicine by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2018 and licensed in 2019, was accepted by the Scottish Medicines Consortium (SMC) for first-line use within NHS Scotland in 2022. The latest NICE decision comes six years after regulatory approval and two years after its initial rejection in the first-line setting.
A third-generation ALK inhibitor, lorlatinib is administered orally once daily and works by inhibiting key enzymes that regulate cell growth and multiplication, thereby preventing cancer cell proliferation and, in some cases, inducing cancer cell death. It was specifically designed to cross the blood-brain barrier and target ALK-resistant mutations, offering potential protection against brain metastases.
Yvonne Diaz, Co-founder and Chair, Oncogene Cancer Research, said:
“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, The University Hospital Birmingham NHS Trust, commented:
“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, added:
“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.”