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Genetech scores sixth FDA approval in lung cancer with Gavreto

Published on 07/09/20 at 12:23pm

Genentech’s once-daily oral therapy Gavreto (pralsetinib) has secured FDA backing in the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), it has emerged.

The decision was made under accelerated approval, marking Genentech’s sixth approval from the US regulator within lung cancer.

According to Phase 1/2 data supplied in support of the ruling, in 87 NSCLC patients who had previously received platinum-based chemotherapy, the therapy recorded a 57% overall response rate (ORR) and a complete response rate (CRR) of 5.7%; however, median duration of response was not met during the study. In 27 treatment-naïve NSCLC patients, the ORR was found to be 70% and CRR was 11%.

These benefits were seen in patients regardless of RET fusion partner or central nervous system involvement.

“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,” commented Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, Genentech’s parent company. “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.”

While the approval has been awarded, the FDA warned that continued approval may be dependent on Genentech reinforcing these positive data with a future confirmatory clinical trial.

Matt Fellows

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