The European Commission granted conditional marketing authorization for pralestinib to treat adults with RET fusion-positive advanced non-small cell lung cancer who have not been treated previously with a RET inhibitor, according to a press release from the manufacturer.

The European Commission based its approval on data from the phase 1/2 ARROW study evaluating pralestinib in patients with advanced RET fusion-positive NSCLC. Results from the trial so far for treatment-naïve patients show an overall response rate of 72% (95% CI, 60.4-81.8). The median duration of response was not reached (95% CI, 9.0 months-NR). 

Among patients who had previously received chemotherapy, researchers reported an overall response rate of 58.8% (95% CI, 50.1-67.2) and a median duration of response of 22.3 months (95% CI, 15.1 months-NR). 

“Today’s approval represents an important step forward in delivering precision medicine to people with RET fusion-positive advanced non-small cell lung cancer, for whom treatment options have historically been limited,” Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said in the release. “By using cancer genomic profiling upfront, healthcare professionals may identify specific alterations that predict clinical benefit of targeted treatment options like pralestinib in the first-line setting.” 

Pralestinib was generally well tolerated during the trial. Adverse reactions included neutropenia, anemia, and hypertension.