Zai Lab Submits New Drug Application for Repotrectinib as a Tumor-Agnostic Therapy Targeting NTRK Gene Fusion-Positive Solid Tumors

Today (April 21),The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recently announced,Submitted by Bristol-Myers Squibb CompanyRipretinib CapsulesNew indications for marketing application have been accepted. Ripretinib (repotrectinib）YesTargeted action onROS1AndNTRKNext-Generation Tyrosine Kinase Inhibitors (TKI) for Carcinogenic Driver GenesZai Lab has exclusive development and commercialization rights for this product in Greater China.

According to the press release from Zai Lab, the indication for this drug's current marketing application is: for the treatment ofCarrying neurotrophic tyrosine receptor kinase (NTRK) gene fusion in adult patients with solid tumors who are locally advanced, metastatic, or for whom surgical resection may lead to severe complications. These patients have experienced disease progression after prior treatments or lack effective treatment options.. For this indication, Ripretinib has already been formally included in the priority review by the CDE.For patients who have previously failed TRK TKI treatmentNTRKFor fusion-positive advanced solid tumors, Ripretinib has also been included by the CDE.Breakthrough Therapy Drug。

Screenshot source: CDE official website

FDA Accelerates Approval of Ripretinib for TreatmentNTRKAdult patients and pediatric patients aged 12 years and older with gene fusion-positive solid tumorsBased on the results of the Phase 1/2 TRIDENT-1 study, which evaluated Repotrectinib inNTRKEfficacy in adult patients with solid tumors. TRIDENT-1 StudyIncluded 40 TKI-naive patients and 48 patients who had received prior TKI treatment, these subjects suffered fromNTRKPositive locally advanced or metastatic solid tumors, covering 15 different types of cancer。Zai Lab participated in the TRIDENT-1 study and was responsible for the execution of the study in Greater China.

TRIDENT-1The study results showed:

• In TKI-naive patients, the median follow-up time was 17.8 months.The confirmed objective response rate (cORR) was 58%., where 43% of patients achieved partial response (PR) and 15% of patients achieved complete response (CR).。Among these patients who achieved remission,83% of patients continued to experience relief one year after receiving Ripretinib treatment., Median Duration of Response (mDOR) has not been reached.

• In patients who had received TKI treatment, the median follow-up time was 20.1 months.cORR was 50%, with 50% of patients achieving PR., no patient achieved CR. In addition,42% of patients who achieved remission remained in remission after one year of treatment with Ripretinib., mDOR was 9.9 months.

• Among patients with evaluable central nervous system (CNS) metastases at baseline, intracranial responses were observed in 2 TKI-naïve patients and 3 patients previously treated with a TKI.

Zai Lab's press release stated that Ripretinib has the potential to become a new generation of TKI drug, which can be widely used to treat various types of tumors.NTRKPatients with fusion-positive solid tumors, including both TKI-naïve and TKI-treated patients.

ThisRipretinib forNTRKThe formal submission for marketing approval of fusion-positive solid tumors in China means that it is expected to benefit more patients in the near future.

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved Apr 22，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[3] Double Joy! Ripretinib sNDA Accepted + Upgraded to Category 1 Recommendation in CSCO Guidelines. Retrieved Apr 21，2025, From https://mp.weixin.qq.com/s/QR0mFmAELoww7mk9aLemBw