GENE ONLINE|News &
Opinion
Blog

2021-10-06| Asia-PacificChina

Zai Lab, Turning Point’s Solid Tumor Treatment Repotrectinib Gets FDA Breakthrough Therapy Designation

by Kathy Huang
Share To

China-based Zai Lab and Turning Point Therapeutics announced that the FDA has granted a breakthrough therapy designation to repotrectinib, which is the seventh regulatory designation repotrectinib got from USFDA.

Repotrectinib is a potential treatment for advanced solid tumor patients with an NTRK gene fusion. It has been treated with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and those have no alternative treatments.

 

What Is Repotrectinib?

Repotrectinib, developed by Turning Point, is a macrocyclic tyrosine kinase inhibitor of ROS1, TRK, and ALK. The treatment can firmly bind to the ATP binding pocket of active kinase, preventing the structural mutations resulting in drug resistance.

According to the Phase 1/2 trial TRIDENT-1 reported in 2020, using repotrectinib to treat ROS1-positive advanced non-small cell lung cancer (NSCLC) patients demonstrated a positive objective response rate (ORR) of 93% with acceptable tolerability. 

The preliminary results also led the FDA to grant repotrectinib a Breakthrough Therapy Designation in patients with ROS1-positive metastatic NSCLC who were TKI-naïve.

Related Article: Checkpoint Inhibitors as Part of Neoadjuvant Therapy in TNBC: Should We Use Them or Not?

 

Recent Collaboration between Zai Lab and Turning Point Therapeutics

In 2020 July, Turning Point out-licensed the development and commercial right of repotrectinib to Zai Lab in Great China. Turning Point received $176 million in the license deal. 

In 2021 January, the two companies broadened their cooperation with a deal worth $361 million, under which Zai Lab gained the exclusive right to develop Turning Point’s TPX-0022, an oncology drug candidate for MET/SRC/CSF1R inhibitor.

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
Zai Lab Buys Rights to Three Assets, Including Its First Neuroscience Drug
2021-11-10
Big Pharma and Non-Profits Join NIH, FDA in New Rare Diseases Drive
2021-10-28
Intellia’s CRISPR Drug Claims FDA Orphan Drug Designation to Treat ATTR Amyloidosis
2021-10-22
LATEST
Novel RAGE Antagonist Stirs Hopes for Countering Diabetic Complications
2021-12-07
AstraZeneca Blocks Private Equity Buyout of Swedish Pharma Sobi
2021-12-06
Coherent Biopharma, WuXi STA Collab Takes a Crack at Peptide-Drug Conjugates
2021-12-06
How CDMOs are Restructuring the Biopharma Landscape – An Interview with Bobby Sheng
2021-12-06
BeiGene launches IPO on Shanghai’s STAR market to raise $3B
2021-12-03
Novartis, UCB Take Aim at Parkinson’s Disease Under $1.65 Billion Collab
2021-12-03
Atara Biotherapeutics’ First-In-Class Allogeneic T-Cell Therapy Accepted for EMA Review
2021-12-02
EVENT
2021-12-13
63rd ASH ANNUAL MEETING AND EXPOSITION
Georgia, USA
2021-12-28
BIOHK2021
Hong Kong, China
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!