Roche’s Cancer Drug Gavreto Wins FDA Approval

GAVRETO is the second breakthrough therapy discovered by Blueprint Medicines that has received FDA approval in 2020.

Gavreto, an oral therapy which selectively targets so-called RET-altered cancers, has been approved by the FDA. The U.S. health regulator has approved the drug for the treatment of patients with a type of non-small cell lung cancer (NSCLC).

The drug has been jointly developed by Roche Holding AG and Cambridge-based Blueprint Medicines Corp.

In July this year, Swiss drugmaker Roche signed an agreement worth up to $1.7 billion with Blueprint Medicines, for rights to Gavreto.

The drug will be jointly marketed in the United States and will be available within a week, Blueprint said. Only about 1-2% of patients with NSCLC have RET fusions, according to Roche.

According to, About 80% to 85% of lung cancers are NSCLC. The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. These subtypes, which start from different types of lung cells are grouped together as NSCLC because their treatment and prognoses (outlook) are often similar.

GAVRETO is a once-daily oral RET-targeted therapy developed by Blueprint Medicines. It is designed to selectively and potently inhibit RET alterations that drive many cancer types, including approximately 1 to 2 percent of patients with NSCLC. Currently, RET is one of seven NSCLC biomarkers that can be targeted with an FDA-approved therapy.

“Targeted therapies have dramatically improved care for patients with non-small cell lung cancer driven by oncogenes, including EGFR and ALK, and the approval of the selective RET inhibitor pralsetinib, or GAVRETO, marks another milestone in a paradigm shift toward precision medicine,” said Vivek Subbiah, M.D., associate professor of Investigational Cancer Therapeutics and center medical director of the Clinical Center for Targeted Therapy at The University of Texas MD Anderson Cancer Center, and an investigator on the ARROW trial.

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