AstraZeneca's Enhertu sBLA Gets FDA Priority Tag for Expanded Use
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has accepted the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu for HER2-low metastatic breast cancer.
The companies are seeking approval for Enhertu to treat unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting.
The sBLA looks to expand the currently 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.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected in the first quarter of 2025. Enhertu has also earlier received the FDA’s Breakthrough Therapy designation in the United States for the treatment of HER2-low or HER2-ultralow metastatic breast cancer.
Year to date, shares of AstraZeneca have risen 15.7% compared with the industry’s growth of 20.1%.
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Filing Based on AZN's DESTINY-Breast06 Study
The latest sBLA was based on 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 37% per blinded independent central review as compared to 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.
The safety profile of Enhertu was similar to that seen in previous studies for breast cancer indications.
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.
ADCs are considered a disruptive innovation in the pharmaceutical industry as these have the potential to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
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 six months of 2024, Enhertu generated $683 million in alliance revenues for AstraZeneca.
AZN's Zacks Rank & Other Stocks to Consider
AstraZeneca currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 8.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 46.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 47.1%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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