EMA Validates Daiichi Sankyo & AstraZeneca Antibody Drug Application

Daiichi Sankyo Company Limited (DSKYF) revealed that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan, a HER2 directed antibody-drug conjugate (ADC), jointly developed by Daiichi Sankyo and AstraZeneca (AZN).

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The antibody-drug is designed to treat adult patients with HER2-positive unresectable or metastatic breast cancer. These include individuals who have received two or more prior anti-HER2-based regimens.

Daiichi Sankyo is engaged in the research, development, manufacture, and sale of pharmaceuticals, while AstraZeneca is a British-Swedish multinational pharmaceutical and biotechnology company.

Supporting Data

Following the EMA’s validation, which indicates the completion of the application, the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) will be initiated.

Notably, this application is based on data from the DESTINY-Breast03 phase 3 trial. The trial showed a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1). Additionally, the safety profile of the most common adverse events with trastuzumab deruxtecan was consistent with prior clinical trials and no new safety concerns were identified.

Globally, breast cancer is the most common cancer, with over two million cases being diagnosed in 2020, resulting in around 685,000 deaths. In Europe, about 531,000 cases of breast cancer are treated annually.

Official Comments

Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said, “We are excited to have submitted a second application this year seeking approval for trastuzumab deruxtecan for a potential third indication in Europe. With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2 positive metastatic breast cancer.”

Wall Street’s Take

Recently, Morgan Stanley analyst Mark Purcell maintained a Buy rating on AZN stock and increased the price target to GBP102 (18.45% upside potential) from GBP100.

Consensus among analysts is a Strong Buy based on 10 Buys, 1 Hold, and 1 Sell. The average AstraZeneca stock forecast of 9,750p implies 13.23% upside potential from current levels. Shares have gained 18.6% over the past year.

News Sentiment

News Sentiment for AstraZeneca is Very Positive based on 51 articles over the past seven days. 100% of the articles on AZN have a Bullish Sentiment, compared to a sector average of 60%.