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September 7, 2020

FDA approves Roche’s Gavreto to treat non-small cell lung cancer

The US Food and Drug Administration (FDA) has granted approval for the use of Roche's Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).

The US Food and Drug Administration (FDA) has approved for the use of Roche’s Gavreto (pralsetinib) to treat adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC).

The FDA provided the authorisation under its accelerated approval programme; continued approval could depend on the validation of clinical benefit in a confirmatory clinical trial.

Gavreto is a once-daily, oral precision treatment that selectively targets RET alterations, including fusions and mutations, commercialised in alliance with Blueprint Medicines.

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.”

FDA approval comes from data of Phase I / II ARROW trial, where Gavreto demonstrated durable clinical responses in RET fusion-positive NSCLC patients with or without prior therapy, irrespective of RET fusion partner or central nervous system involvement.

Furthermore, the drug led to an overall response rate (ORR) of 57% and complete response (CR) rate of 5.7% in the 87 NSCLC patients who previously received platinum-based chemotherapy.

Roche noted that it did not achieve the median duration of response (DoR). ORR was 70% and the CR rate was 11% in the 27 participants with treatment-naïve NSCLC.

The most common adverse reactions were fatigue, constipation, musculoskeletal pain and increased blood pressure.

Last month, Roche secured the FDA approval for Enspryng (satralizumab-mwge) for the treatment of anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) in adults.

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