Odonate's Oral Taxane Tesetaxel Shows PFS Benefit In Metastatic Breast Cancer Phase III

The convenient oral therapy could have benefits over more traditional infused taxane chemotherapies, and a new drug application filing is planned for 2021.

Stepping stones
Odonate hopes tesetaxel is on the path to FDA approval • Source: Shutterstock

Odonate Therapeutics, Inc. is edging closer to bringing its first cancer therapy to market. Tesetaxel, a next-generation chemotherapy, could have convenience and tolerability benefits over older taxane chemotherapies like paclitaxel and docetaxel.

The company announced on 24 August that a Phase III trial testing tesetaxel in patients with HER2-negative, HR-positive metastatic breast cancer met the progression-free survival primary endpoint

More from Clinical Trials

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By 

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from R&D

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By 

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.