Roche has secured the European Commission (EC) conditional marketing authorisation for Gavreto (pralsetinib) to treat a type of non-small cell lung cancer (NSCLC).
The drug was indicated for the treatment of rearranged during transfection (RET) fusion-positive advanced NSCLC, who were previously not treated with a RET inhibitor.
Gavreto is a once-daily, oral precision medicine that works by selectively targeting rearranged during transfection (RET) alterations, including fusions and mutations.
The drug is being developed by Roche, in global partnership with Blueprint Medicines, except in certain regions in Asia, including China.
According to the company, Gavreto is the first and only precision medicine approved in the European Union (EU) for the first-line treatment of RET fusion-positive advanced NSCLC.
Roche chief medical officer and global product development head Levi Garraway said: “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.
“By using cancer genomic profiling upfront, healthcare professionals may identify specific genetic alterations that predict clinical benefit of targeted treatment options like Gavreto in the first-line setting.”
The EC approval is based on results of the ongoing Phase 1/2 ARROW study, which assessed the safety, tolerability and efficacy of Gavreto in the US, Europe and Asia.
The trial enrolled in people with RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer and other RET-altered solid tumours.
In the study, the orally administered Gavreto showed durable responses in people with advanced RET fusion-positive NSCLC.
The drug showed 72% overall response rate (ORR) in 75 treatment-naïve patients, where median duration of response (DOR) was not reached.
Gavreto showed an ORR of 58.8%, and median DOR was 22.3 months in 136 patients who had previously received platinum-based chemotherapy.
The drug was generally well-tolerated, with a low rate of treatment discontinuation, common grade 3-4 adverse reactions were neutropenia, anaemia and hypertension.
Gavreto was previously approved in the US, for the treatment of adults with metastatic RET fusion-positive NSCLC, and for the treatment of advanced RET-altered thyroid cancers.
It was also approved in Canada, mainland China and Switzerland.
Roche intends to file regulatory submission with the EU regulator, for additional indication of RET-altered thyroid cancers.
