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Seattle Genetics Submits NDA to FDA for Tucatinib Combo

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Seattle Genetics, Inc. (SGEN - Free Report) announced that it submitted a new drug application (NDA) to the FDA for its oral tyrosine kinase inhibitor tucatinib in combination with Roche's (RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine). The NDA was submitted seeking approval to treat patients with locally advanced/metastatic HER2-positive breast cancer, including those with brain metastases who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting.

The NDA submission was supported by results from the HER2CLIMB study, comparing tucatinib added to Herceptin and Xeloda versus Herceptin and Xeloda alone. This is the first investigational therapy in a pivotal study to address an unmet need for patients with metastatic HER2-positive breast cancer with or without brain metastases.

Shares of the company have soared 103.2% compared with the industry growth of 9.8%.


Recently, the FDA granted Breakthrough Therapy designation to the combo to treat patients with locally advanced/metastatic HER2-positive breast cancer, including those with brain metastases and previously treated with Herceptin, pertuzumab and T-DM1.This designation was granted based on data from the HER2CLIMB study.

Notably, in October, AstraZeneca (AZN - Free Report) and its Japanese partner Daiichi Sankyo Company announced that the FDA granted Priority Review to the biologics license application (“BLA”) for their antibody drug conjugate candidate, trastuzumab deruxtecan. In this BLA, the companies are seeking FDA approval for the candidate as a potential treatment for HER2-positive metastatic breast cancer. A decision is expected in the second quarter of 2020.


Zacks Rank & Stock to Consider

Seattle Genetics is a Zacks Rank #3 (Hold) stock, currently.

A better-ranked stock in the biotech sector is Alkermes Plc. (ALKS - Free Report) , sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 90 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.  

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