Lorbrena Approved to Treat ALK-Positive Lung Cancer
November 2, 2018 – The U.S. FDA has approved Lorbrena® (lorlatinib), an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) manufactured by Pfizer. Lorbrena is indicated to treat patients who have ALK-positive metastatic non-small cell lung cancer (NSCLC) and whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease. It is also indicated for patients whose ALK-positive metastatic NSCLC has progressed on alectinib or ceritinib.
Patients who are ALK-positive have a type of genetic abnormality in which two genes, the ALK gene and the EML4 gene (echinoderm microtubule-associated protein like 4) fuse together. The resulting mutation codes for the production of abnormal tyrosine kinase proteins that drive the growth of cancer cells. Up to 8% of patients diagnosed with NSCLC are ALK-positive, and an estimated 70% of these patients relapse after treatment and experience brain metastasis. TKI medications like Lorbrena work to block the signals that fuel cancer cell growth.
In a clinical trial, Lorbrena produced an overall response rate (ORR) of 48%. Of the patients who responded to treatment, 57% had received previous treatment with more than one ALK TKI medication. Additionally, 69% of trial participants had a history of brain metastases; the intracranial response rate with Lorbrena was 60%. Recommended dosing is 100mg taken once daily.
Lorbrena will be available in 25mg and 100mg dosage strengths. Pfizer has not yet announced launch plans, but Lorbrena is expected to have a wholesale acquisition cost (WAC) of approximately $193,000 per year.