ALK Biomarkers

With FDA clearance of its IND, the company has begun studying the drug's dosing and preliminary activity in previously treated, ALK-positive, advanced NSCLC.

Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.

The biotech will begin clinical trials of its lead drug candidates in ROS1-positive and ALK-positive non-small cell lung cancer in 2021 and 2022, respectively.

The test will be used in the trial to improve understanding of molecular resistance mechanisms to Pfizer's Lorviqua and other ALK inhibitors.

The agency approved the drug based on a study that showed an 88 percent response rate in young patients with ALK-positive anaplastic large cell lymphoma.

The study is evaluating the drug in previously treated NSCLC patients with alterations in EGFR, ALK, ROS1, NTRK, BRAF, MET, or RET.

The agency recommended the drug based on the results from the Phase III ALTA-1L trial, and after Takeda agreed to offer the drug to NHS England at a discount.

The studies will evaluate Lorbrena in patients with newly diagnosed, high-risk neuroblastoma whose tumors harbor an ALK gene mutation.

The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.