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FDA approved Roche’s Gavreto for RET fusion-positive NSCLC

Updated: Jun 27, 2023

Roche has announced that it has received approval from the U.S. Food and Drug Administration for Gavreto (pralsetinib). The drug is indicated for treating RET fusion-positive non-small cell lung cancer. The drug is indicated for treating RET-altered cancers.

The approval is based on phase I/II ARROW study; patients with RET fusion-positive NSCLC with or without prior therapy were included in the trials.

  • 57% of patients showed an overall response rate (ORR)

  • 70% of treatment naïve patients showed an overall response rate (ORR)

  • 5.7% of patients showed a complete response (CR)

The median duration of response was not reached. Fatigue, constipation, musculoskeletal pain, and increase blood pressure were the adverse events observed during the treatment.

Gavreto has received an Accelerated Approval program, based on Phase I/II ARROW study. Further, it has received a priority review designation for treating patients with RET-medullary thyroid cancer and RET-fusion-positive thyroid cancer.

The drug will be commercialized by Roche along with Blueprint Medicines in the United States and is the sixth product from Roche for NSCLC.

About RET-activating fusions:

RET-activating fusion and mutations are drivers for the development of several cancers, including thyroid cancers and non-small cell lung cancers.

RET-fusions constitute only 1-2% of NSCLC cancers. Identifying fusions are a crucial factor in determining the treatment for these cancers.


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