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AstraZeneca's (AZN) Enhertu Gets EU Nod for Breast Cancer

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AstraZeneca (AZN - Free Report) and its Japan-based partner Daiichi Sankyo announced that the European Commission has granted conditional approval to their cancer drug, Enhertu (trastuzumab deruxtecan) for third-line HER2-positive metastatic breast cancer.

Enhertu can now be prescribed in the EU for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. The approval was expected as in December 2020, the Committee for Medicinal Products for Human Use of the European Medicines Agency had recommended approving Enhertu for this disease.

The approval was based on positive results from the randomized DESTINY-Breast01 phase II study. Data from the study showed that treatment with Enhertu, an antibody drug conjugate, led to a clinically meaningful and durable antitumor activity in the above patient population.

Following the EU approval for the breast cancer indication, AstraZeneca is due to make a milestone payment of $75 million to Daiichi Sankyo.

Enhertu is approved for the same indication in the United States and Japan. In the United States, Enhertu was approved for the second indication — HER2-positive metastatic gastric cancer for patients who have received a prior trastuzumab-based regimen — earlier this week.

In the past year, AstraZeneca’s shares have risen 2.8% compared with an increase of 6.1% for the industry.



AstraZeneca had acquired joint development and commercialization rights to Enhertu from Daiichi in April 2019. Sales of Enhertu in the United States are recognized by Daiichi Sankyo while AstraZeneca records its share of profit from sales of the drug in the United States as collaboration revenues. In the first nine months of 2020, Enhertu generated collaboration revenues of $63 million for AstraZeneca. The collaboration revenues should increase with the FDA approval for the gastric cancer indication and the EU approval for breast cancer indication this week.

Meanwhile, Enhertu is being evaluated in other phase III breast cancer studies in earlier line settings and stages of disease.

Enhertu is part of AstraZeneca’s flourishing oncology portfolio. Other key oncology drugs in AstraZeneca’s portfolio are Tagrisso, Lynparza and Imfinzi. AstraZeneca markets Lynparza in partnership with Merck (MRK - Free Report) .

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked biotech stocks are Alkermes (ALKS - Free Report) and Alexion Pharmaceuticals (ALXN - Free Report) . While Alkermes has a Zacks Rank #1 (Strong Buy), Alexion has a Zacks Rank #2 (Buy).

Alkermes’ shares have risen 20.3% in the past year.

Alexion’s shares have gained 39.7% in the past year while its earnings estimates for 2021 have risen 3% over the past 90 days.

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