Market News

AstraZeneca’s Enhertu Wins Approval in EU by CHMP

Story Highlights

Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan have been recommended for approval in the European Union for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

AstraZeneca (GB:AZN) announced that Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan, also known as Enhertu, has been recommended for marketing authorization in the European Union (EU) by the Committee for Medicinal Products for Human Use (CHMP).

It is approved as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

Trastuzumab deruxtecan is a HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

The recommendation is based on DESTINY-Breast03 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1).

The European Commission, which has the authority to grant marketing authorizations for medicines in the EU, will review the recommendation.

Management Weighs In

Susan Galbraith, MBBChir, PhD, EVP of Oncology R&D at AstraZeneca, commented, “This recommendation reflects the transformative progression-free survival benefit seen in the DESTINY-Breast03 trial compared to T-DM1, supporting trastuzumab deruxtecan as a potential new standard of care and setting a new benchmark in the treatment of HER2 positive metastatic breast cancer.”

She further added, “If approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their disease, improving their chance for better outcomes.”

Wall Street’s Take

Last week, Deutsche Bank analyst Emmanuel Papadakis reiterated a Buy rating on AstraZeneca with a price target of GBp 11,500 (7.6% upside potential).

The rest of the Wall Street community is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on nine Buys and three Holds. At the time of writing, the average AstraZeneca price target of GBp 11,231.82 implies 2.69% downside potential to current levels.

TipRanks’ Smart Score

AZN scores an 8 out of 10 on TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.

Take Away

Over 530,000 cases of breast cancer are diagnosed in Europe each year, with 20% of breast cancer cases being HER2-positive.

The approval and subsequent marketing authorizations for the medicines in the EU could boost revenues and profitability for the company.


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