1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Seattle Genetics Poised For Big Breast Cancer Launch On Positive Tucatinib Data

 
• By Jessica Merrill

The company expects to file an NDA for tucatinib in the first quarter after a pivotal trial showed a significant improvement in PFS and OS for patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.

SC1910_Yellow-umbrella_291917768_1200.jpg
Seattle Genetics hopes to differentiate tucatinib from other HER2-targeting cancer drugs. • Source: Shutterstock

Seattle Genetics Inc. appears on track to bring a competitive new drug to market for advanced or metastatic HER2-positive breast cancer late next year in what is an increasingly crowded therapeutic area. The company said on 21 October that it expects to file a new drug application (NDA) with the US Food and Drug Administration in the first quarter of 2020 for an oral tyrosine kinase inhibitor that is selective for HER2, tucatinib, which provided notable progression-free survival (PFS) and overall survival (OS) benefits for patients in an interim look at a pivotal clinical trial.

Due to the positive result, the trial was unblinded and all patients will be given tucatinib going forward. The positive...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

2025’s Biggest Launches – Half-Year Progress Report

 
• By Andrew McConaghie

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Will AstraZeneca Reach Summit And Be A PD-1xVEGF Player?

 
• By Kevin Grogan

Rumor mill suggests a $15bn licensing deal for ivonescimab is in the offing.

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By Manas Mishra

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

More from R&D

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 
• By Dexter Jie Yan

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

Novartis’s Cosentyx Suffers Rare Phase III Fail

 
• By Kevin Grogan

Multi-blockbuster falls short in a giant cell arteritis study.