CStone's new indications for RET inhibitors are planned to be included in priority review

Source: Guanlan Pharmaceutical

According to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, the new indication application of CStone's RET inhibitor pralsetinib capsule has been included in the proposed priority review on April 8.

Screenshot source: CDE official website

Transfection rearrangement (RET) activating fusions and mutations are key disease drivers for many cancer types.

Pratinib is a powerful and highly selective oral precision therapy developed by Blueprint Medicines that targets oncogenic RET mutations (including predictable drug-resistant mutations).

In China, pratinib was approved for the first time in March this year for the treatment of "adult patients with locally advanced or metastatic non-small cell lung cancer who have previously received platinum-containing chemotherapy and RET gene fusion-positive.

In a phase 1/2 clinical trial called ARROW, researchers evaluated the effect of pratinib in the treatment of RET-mutant medullary thyroid cancer and RET-fusion-positive thyroid cancer.

In December 2020, the US FDA has accelerated the approval of new indications for pratinib based on the results of the study for the treatment of patients with RET-mutated thyroid cancer, including advanced or metastatic RET-mutated thyroid patients over 12 years of age who require systemic treatment.

This time, platinib's plan to be included in the priority review means that the drug's new indication for thyroid cancer is also expected to accelerate its approval in China and benefit more patients as soon as possible.