Lorbrena Gains Full FDA Approval, Expanded Lung Cancer Indication

March 3, 2021 – The U.S. FDA has granted Pfizer’s Lorbrena® (lorlatinib) full approval after first issuing an accelerated approval in 2018. The agency has also expanded Lorbrena’s approved indication to include first-line treatment of metastatic, anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) in adults. Initially, the medication was only approved for use in patients who had progressed following prior therapy.

Lung cancer is a leading cause of cancer deaths worldwide, with NSCLC accounting for up to 85% of lung cancer diagnoses. The presence of an ALK mutation (found in 3-5% of NSCLC cases) is associated with more aggressive disease, as the mutation drives rapid development of cancer cells. Lorbrena is designed to inhibit tumor mutations that contribute to treatment resistance. It is also able to cross the blood-brain barrier, meaning it may deliver improved results for patients whose NSCLC has spread to the brain.

In a confirmatory clinical trial, Lorbrena reduced the risk of death or disease progression by 72% compared to Xalkori® (crizotinib), an FDA-approved treatment also manufactured by Pfizer, in patients who had received no prior treatment for ALK+ NSCLC. In addition, Lorbrena delivered superior numbers compared to Xalkori in terms of intracranial objective response rate (IC-ORR) and intracranial duration of response (IC-DOR) in patients who had brain metastases. The IC-ORR for Lorbrena was 82% versus 23% for Xalkori. Lorbrena also delivered a 12-month or longer IC-DOR in 79% of patients with brain metastases. No patients with brain metastases who received Xalkori reached a 12-month IC-DOR in the study.

Recommended Lorbrena dosing is 100mg taken by mouth at approximately the same time each day, with or without food, until disease progression or unacceptable toxicity occur. Dosing modification may be necessary based on adverse reactions and/or other medications the patient may be taking.