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New Drugs Approved In September

Gavreto
Gavreto

The FDA granted accelerated approval to Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

Developed by Blueprint Medicines (BPMC), Gavreto is a once-daily, oral precision therapy that selectively targets RET alterations, including fusions and mutations, regardless of the tissue of origin.

Gavreto, priced at about $19,250 a month, will be co-commercialized by Roche’s Genentech and Blueprint Medicines.

The drug comes with warnings about pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, and impaired wound healing.

Gavreto will have to compete with Eli Lilly’s Retevmo, which is also a selective RET kinase inhibitor. The FDA granted accelerated approval to Gavreto for the treatment of lung and thyroid cancers in May this year.