Detailed explanation of the launch time and effects of ROS1-positive lung cancer drug Ripotinib

Introduction: Ripretinib, a new generation ROS1 inhibitor, is used for patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) and can also be used to treat advanced gastrointestinal stromal tumors (GIST). Ripotinib has been approved by the FDA in the United States. This article mainly talks about the launch time, effects, medication reference, medication for special groups, etc. of Ripotinib.

Time to launch

The launch time of Ripotinib in the United States is November 15, 2023. Zai Lab announced on June 28, 2023 that the China National Medical Products Administration ( The NMPA has accepted the new drug marketing application for Repotrectinib, and Zai Lab has obtained the exclusive development and commercialization rights for Repotrectinib in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).

Effects

1. High response rate: In the TRIDENT-1 study, repotinib showed a high objective response rate (ORR). For treatment-naïve patients who had not used ROS1 TKIs, the ORR reached 79%. Among patients who had previously received a ROS1 TKI but had not received chemotherapy, the ORR was 38%.

2. Durable efficacy: Among TKI-naïve patients, the median progression-free survival (PFS) of repotinib was 35.7 months, and the median duration of response (mDOR) was 34.1 months. This suggests that repotinib can provide patients with long-term disease control.

3. Effective against drug-resistant mutations: Ripotinib has shown efficacy in ROS1 TKI-naïve patients and patients with ROS1 drug-resistant mutations, including patients with ROS1 G2032R drug-resistant mutations.

4. Good intracranial activity: Ripotinib also shows strong efficacy in patients with brain metastases. Intracranial responses have been observed in both patients with brain metastases who have not received TKI treatment and those who have received TKI treatment.

5. Overcoming drug resistance potential: Ripotinib can overcome the known ALK, ROS1 and NTRK drug resistance problems that have emerged in clinical practice, and has outstanding ability to combat drug resistance.

Medication Reference

Repretinib is administered as oral therapy at a recommended dose of 160 mg once daily for 14 days, then increased to 160 mg twice daily until disease progression or unacceptable toxicity occurs. Ripotinib should be taken according to the doctor's prescription instructions, and communication with the doctor should be maintained during the medication so that possible problems can be dealt with in a timely manner.

Usage in Special Populations

For patients with hepatic and renal insufficiency, dosage adjustment or additional monitoring may be required. Advise females of childbearing potential to use effective non-hormonal contraception during treatment and for 2 months after the last dose. Recommended doses of repotinib have not been established in patients with severe renal impairment or renal failure, or in patients with moderate or severe hepatic impairment, and lactating women are advised to discontinue breastfeeding during treatment and for 10 days after the last dose.

When using repotinib, patients should follow the doctor's prescription and instructions, and maintain communication with the doctor during the medication so that possible problems can be dealt with in a timely manner.