AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer in the United States. The approval of the added indication has triggered a $175 million milestone payment from AstraZeneca to Daiichi Sankyo.

The companies’ sBLA was seeking approval for Enhertu to treat unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting.

The nod in the United States expands the approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. The drug has earlier received the FDA’s Breakthrough Therapy designation in the United States for this new indication.

In three months, shares of AstraZeneca have lost 6.8% compared with the industry’s 9.5% decline.

Image Source: Zacks Investment Research

FDA Approval Based on AZN's DESTINY-Breast06 Study Data

The FDA approval of AstraZeneca’s sBLA was based on positive data from the phase III DESTINY-Breast06 study, which compared Enhertu to chemotherapy.

Data from the study showed that treatment with Enhertu reduced the risk of disease progression or death by 36% in the overall patient population of the study as compared to chemotherapy. The confirmed objective response rate in the overall study population was 62.6% for Enhertu compared with 34.4% for chemotherapy.

Also, treatment with Enhertu in patients with HER2-low expression led to progression-free survival (PFS) of 13.2 months as compared to 8.1 months for chemotherapy. This was the primary endpoint of the study. In patients with HER2-ultralow expression, treatment with Enhertu demonstrated a median PFS of 13.2 months versus 8.3 months for chemotherapy. Thus, results were consistent between patients with HER2-low expression and HER2-ultralow expression.  

The safety profile of Enhertu was similar to that seen in previous studies for breast cancer indications. No new safety concerns were observed. Similar regulatory filings based on the DESTINY-Breast06 study data are currently under review in several other geographies, including the EU and Japan.

Enhertu — A Key Oncology Drug for AZN

Enhertu, a specifically engineered HER2-directed antibody-drug conjugate (ADC), is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and solid tumors.

Daiichi Sankyo recognizes the U.S. sales of Enhertu while AstraZeneca records its share of gross profit margin from Enhertu sales under Alliance revenues. In the first nine months of 2024, Enhertu generated $1.05 billion in alliance revenues for AstraZeneca.

AstraZeneca PLC Price and Consensus

AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote

AZN's Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY. While CSTL and BMRN currently sporta Zacks Rank #1 (Strong Buy) each, ALNY carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 39 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $ 1.70. In the past three months, shares of Castle Biosciences have plunged 21.1%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 11.6%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.

In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 40 cents. In the past three months, shares of Alnylam Pharmaceuticals have lost 2.8%.

ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

AstraZeneca PLC (AZN) : Free Stock Analysis Report

Alnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report

BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report

Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research