Roche has secured approval from the US Food and Drug Administration (FDA) for its Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
Gavreto, a once-daily and oral precision therapy, will help selectively target RET alterations such as fusions and mutations irrespective of the tissue of origin.
Roche’s wholly-owned member Genentech and Blueprint Medicines will jointly commercialise Gavreto in the US. Roche will commercialise the drug outside of the US, excluding Greater China.
The accelerated approval of Gavreto for this indication is based on data from the phase I/II ARROW study.
ARROW is a phase I/II, open-label and first-in-human study focused on the assessment of safety, tolerability and efficacy of Gavreto administered orally in people with rearranged during transfection (RET) fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), RET fusion-positive thyroid cancer and other RET-altered solid tumours.
According to the company, Gavreto generated durable clinical responses in people with RET fusion-positive NSCLC with or without prior therapy and irrespective of RET fusion partner or central nervous system involvement in phase I/II ARROW study.
Gavreto is said to Roche’s sixth FDA-approved medicine in its portfolio of treatments for lung cancer. The FDA awarded breakthrough therapy status to Gavreto to treat RET fusion-positive NSCLC that has advanced following platinum-based chemotherapy and for RET mutation-positive MTC that needs systemic treatment.
The company also secured a priority review for Gavreto to treat people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer. The approval decision is expected by the end of February 2021.
Roche chief medical officer and global product development head Levi Garraway said: “The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease.
“We remain committed to finding personalised treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumour types.”
In August this year, Roche secured approval from the FDA for its Evrysdi (risdiplam) to treat spinal muscular atrophy (SMA) in adults and children aged two months of age and older.