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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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