Lorbrena (loraltinib) receives conditional approval for treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC).

Following US Food and Drug Administration (FDA) approvals for lung cancer drug Vizimpro (dacomitinib) in September and breast cancer treatment Talzenna (talazoparib) in October, Pfizer has snagged its third cancer drug approval in two months.

Lorbrena (loraltinib) a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase
inhibitor (TKI) has received conditional approval from the FDA for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed while taking Pfizer’s drug Xalkori (crizotinib) and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on Roche’s Alecensa (alectinib) or Xalkori, as the first ALK inhibitor
therapy for metastatic disease.

Pfizer is hoping the approval will help boost its position in the ALK-positive market, as Xalkori faces increasing competition from Alecensa and Novartis’ Zykadia. In addition, Takeda’s Alunbrig, which has already been approved as a second-line therapy, could soon receive approval as a front-line treatment. Pfizer is currently evaluating Lorbrena as a first-line therapy alone and also in combination with Bavencio (avelumab), a PD-1/PD-L1 it developed with Merck KGaA. 

The conditional approval means that the FDA will be looking to confirm the positive results obtained for Lorbrena in a phase 1/2 study in further clinical trials.