Roche Withdraws One Indication for RET Inhibitor Pralsetinib and Returns Global Rights to Blueprint Medicines

After communicating with the FDA, Genentech, a subsidiary of Roche, decided to withdraw Gavreto (pralsetinib) for the treatment of advanced RET-mutant medullary thyroid cancer. The drug's original developer, Blueprint, disclosed this news in a securities filing on Friday.

Genentech stated that its decision to withdraw the indication was not due to any new safety or efficacy data or product safety or quality issues with Gavreto, and other indications approved for Gavreto in the United States remain unaffected.

Based on the tumor shrinkage data from the I/II phase ARROW trial, Gavreto received accelerated FDA approval on December 1, 2020, for the treatment of advanced or metastatic rearranged during transfection (RET) mutant medullary thyroid cancer (MTC) in children aged 12 years and older and adults requiring systemic therapy. However, Roche now believes that the phase III AcceleRET-MTC trial, which aimed to convert this approval into a full approval, is no longer feasible.

Although the indication for RET-mutant medullary thyroid cancer has been withdrawn, Gavreto remains approved for RET fusion-positive thyroid cancer and adult RET fusion-positive non-small cell lung cancer. Following the product's market launch, the FDA requested additional data on patients from the ARROW and TAPISTRY trials.

Medullary thyroid carcinoma accounts for only a small portion of Gavreto's sales. Last year, the total revenue of this RET inhibitor was merely 26 million Swiss francs. Meanwhile, Roche decided to terminate its partnership with Blueprint in February this year and returned the rights of Gavreto to the Massachusetts-based biotech company. The two companies are in a transitional phase, and the "breakup" agreement will take effect in February 2024 (see:).

Blueprint stated that the termination of the transaction would not affect its 2023 revenue guidance, including collaboration revenue of $40 million to $50 million from existing partnerships or the expected operating expenses for 2023.

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