FDA Approves Companion Diagnostic for ALK-Positive Non–Small Cell Lung Cancer Treatment


The VENTANA ALK CDx assay is a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who are eligible to receive treatment with lorlatinib.

The FDA has approved the VENTANA ALK (D5F3) CDx assay as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer (NSCLC) who are eligible to receive treatment with lorlatinib (Lorbrena).1

On March 3, 2021, the FDA gave the green light to expand the indication of lorlatinib to include use in the frontline treatment of patients with ALK-positive NSCLC based on data from the phase 3 CROWN trial (NCT03052608), where the agent led to a 72% reduction in the risk of progression or death vs crizotinib (Xalkori) in treatment-naïve patients (HR, 0.28; 95% CI, 0.19-0.41; <.0001) per blinded independent central review assessment.2

Previously, in November 2018, the regulatory agency granted an accelerated approval to lorlatinib for use in patients with ALK-positive NSCLC whose disease had progressed on crizotinib and at least 1 other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor treatment for metastatic disease. The decision was based on a subgroup of 215 patients with ALK-positive metastatic NSCLC from Study B7461001 (NCT01970865), in which lorlatinib elicited an overall response rate of 48% (95% CI, 42%-55%).3

“The FDA approval is great news for [patients with] ALK-positive [NSCLC],” Jill German, head of Roche Pathology Customer Segment, stated in a press release. “It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy. This label expansion advances Roche’s commitment to personalized healthcare by providing [patients with] lung cancer with access to more treatment options and a better chance for progression-free survival compared to standard of care.”

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