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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.

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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...

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Boehringer Ingelheim Expects Two Key Approvals In Second Half Of 2025

 
• By Andrew McConaghie

The privately held German pharma firm is hoping to bring a new generation of pulmonary fibrosis and cancer drugs to market but their commercial success is not yet a certainty.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 
• By Jessica Merrill

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

More from R&D

AZ Poised To Bring Self-Administered C5 Inhibitor To Market

 
• By Jessica Merrill

Gefurulimab will give AstraZeneca a new option to compete against Argenx’s Vyvgart Hytrulo, which is available subcutaneously.

Leo Looks To Grow In US After Hand Eczema Cream Approval

 
• By Kevin Grogan

The Danish medical dermatology specialist doubles boosts its sales force ahead of the launch of Anzupgo.

Obesity Beyond GLP-1s: Amylins – The Next Frontier

 
• By Aakash Babu

In this series of articles, we look at different mechanisms of actions beyond GLP-1s that could determine the obesity drug landscape in the coming years. First on our list – amylin receptor agonists, which analysts expect to grow into a $50bn market opportunity.