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

Immuneering Could Partner Atebimetinib Or Go It Alone After Phase IIa Success

 
• By Alaric DeArment

CEO Ben Zeskind said all options are on the table after atebimetinib showed impressive results in pancreatic cancer.

Enliven Raises $230m To Fund Scemblix Leukemia Challenger

 
• By Andrew McConaghie

The company believes its drug could eventually displace Novartis’s Scemblix in first-line chronic myeloid leukemia treatment, but for now is preparing for a second-/third-line pivotal study.

BMS’s Breyanzi Stands To Further Expand Broad Lymphoma Coverage

 
• By Alaric DeArment

The drugmaker presented data at a lymphoma meeting showing strong efficacy for the CAR-T in marginal zone lymphoma, the second most common indolent lymphoma.

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By Kevin Grogan

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

More from R&D

Early Blood Cancer Data Impresses As Incyte Plots Post-Jakafi Strategy

 
• By Kevin Grogan

First results for a first-in-class mutCALR-targeted therapy in essential thrombocythemia presented at EHA point to a lucrative future for the early-stage product.

Who Dares Wins? Roche Moves Parkinson’s Candidate Into Phase III Despite Near Miss

 
• By Andrew McConaghie

Open-label extension data have persuaded Roche to move prasinezumab into Phase III, where it believes a few tweaks to the study design could turn a near miss into success.

Pipeline Watch: Eight Approvals And Ten 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.