Pfizer announced that the Food and Drug Administration (FDA) has approved Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on: crizotinib and at least 1 other ALK inhibitor for metastatic disease; or alectinib as the first ALK inhibitor therapy for metastatic disease; or ceritinib as the first ALK inhibitor therapy for metastatic disease.
Lorbrena, a third generation ALK tyrosine kinase inhibitor (TKI), has been approved under the accelerated pathway based on tumor response rate and duration of response. Continued approval may be based on verification and description of clinical benefit in a confirmatory trial.
The FDA approval was supported by data from a non-randomized, dose-ranging and activity-estimating, multi-cohort, multicenter Phase 1/2 study that evaluated Lorbrena in patients with ALK-positive metastatic NSCLC who were previously treated with 1 or more ALK TKIs (N=215) .
Results showed an overall response rate (ORR) of 48% (95% CI, 42%, 55%) among treated patients (4% complete response; 44% partial response); 57% of patients had previous treatment with >1 ALK TKI. The median duration of response was 12.5 months (95% CI, 8.4, 23.7). In addition, an assessment of intracranial ORR showed a 60% response rate (95% CI, 49%, 70%) among patients with measurable intracranial lesions; 69% of patients had a history of brain metastases. The median duration of response in these patients was 19.5 months (95% CI, 12.4, not reached [NR]).
The most frequent adverse reactions reported with treatment included edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea.
“Lorbrena’s approval is an important milestone for patients, having demonstrated marked activity in a study that included a broad range of individuals with ALK-positive non-small cell lung cancer. This includes patients who were heavily pretreated and facing limited options after receiving first- and second-generation ALK tyrosine kinase inhibitors,” stated Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development.
Lorbrena will be available as 25mg and 100mg strength tablets in 30-count bottles.
For more information call (800) 438-1985 or visit Lorbrena.com.