Lorlatinib has been approved by the FDA for the treatment of metastatic ALK-positive NSCLC.

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August 2021: Lorlatinib (Lorbrena, Pfizer Inc.) received regular FDA approval for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive, as determined by an FDA-approved test.

The Ventana ALK (D5F3) CDx Assay (Ventana Medical Systems, Inc.) was also authorised by the FDA as a lorlatinib companion diagnostic.

Lorlatinib was approved for the second- or third-line treatment of ALK-positive metastatic NSCLC in November 2018.

Study B7461006 (NCT03052608), a randomised, multicenter, open-label, active-controlled trial in 296 patients with ALK-positive metastatic NSCLC who had not had prior systemic therapy for metastatic illness, was used to support the present approval. The VENTANA ALK (D5F3) CDx assay has to detect ALK-positive malignancies in the patients. Patients were randomly assigned to receive either lorlatinib 100 mg or crizotinib 250 mg orally twice daily (n=147).

Blinded independent central review (BICR) found that Study B7461006 improved progression-free survival (PFS), with a hazard ratio of 0.28 (95 percent CI: 0.19, 0.41; p0.0001). The median PFS in the lorlatinib arm was not determined, while it was 9.3 months (95 percent CI: 7.6, 11.1) in the crizotinib arm. At the time of the PFS study, the overall survival data was only in its infancy.

Involvement of the central nervous system (CNS) was investigated in all individuals. Based on baseline brain imaging, 17 patients in the lorlatinib arm and 13 in the crizotinib arm had detectable CNS abnormalities. The intracranial ORR was 82 percent (95 percent CI: 57, 96) in the lorlatinib arm and 23 percent (95 percent CI: 5, 54) in the crizotinib arm, according to the BICR. In the lorlatinib and crizotinib arms, the duration of intracranial response was 12 months in 79 percent and 0 percent of patients, respectively.

Edema, peripheral neuropathy, weight gain, cognitive effects, fatigue, dyspnea, arthralgia, diarrhoea, mood effects, hypercholesterolemia, hypertriglyceridemia, and cough were the most prevalent side events (incidence 20%), which included Grade 3-4 laboratory abnormalities.

Lorlatinib is taken orally once a day at a dose of 100 mg.

Reference : https://www.fda.gov/

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