AstraZeneca AZN announced that the FDA has approved its antibody-drug conjugate (ADC), datopotamab deruxtecan (or Dato-DXd), in patients with a certain type of breast cancer. The drug, developed in partnership with Japan-based Daiichi Sankyo, will be marketed under the brand name Datroway.
Post the FDA’s approval, the ADC drug is approved to treat unresectable or metastatic HR-positive, HER2-negative breast cancer in adult patients who have received prior endocrine-based therapy and chemotherapy.
This approval came just a few weeks after Daiichi secured approval for the drug for a similar indication in Japan. The approvals in the United States and Japan are based on data from the phase III TROPION-Breast01 study, which showed that treatment with Datroway significantly reduced the risk of disease progression or death by 37% compared to the investigator’s choice of chemotherapy in the above indication.
Per AstraZeneca, Datroway is part of a select group of therapies that could achieve peak annual sales of at least $5 billion. These medicines are part of management’s ambitious growth strategy to achieve $80 billion in annual revenues by 2030.
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In the past year, AstraZeneca’s shares have lost nearly 1% compared with the industry’s 5.4% decline.
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Recent Developments With AZN’s Datroway
Datroway is the second ADC drug developed under the AstraZeneca-Daiichi partnership, the first being the blockbuster Enhertu. Per the terms of the partnership, both companies are jointly responsible for developing and marketing the drugs worldwide, except Japan, where Daiichi maintains exclusive rights for both. Daiichi is also responsible for the manufacturing and supply of both Enhertu and Datroway.
AZN and partner Daiichi are currently evaluating Datroway in an extensive clinical development program as both a monotherapy and in combination with other drugs across multiple cancer indications, including breast and lung cancers. This includes seven late-stage programs across lung cancer indications and five in breast cancer.
Last week, management announced that a regulatory filing was granted priority review by the FDA, seeking approval for Datroway to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). A final decision is expected in third-quarter 2025. The drug was granted breakthrough therapy designation by the FDA in this indication last month.
ADCs like Enhertu and Datroway are being considered disruptive innovations in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
FDA Expands Label for AZN’s Cancer Drug Calquence
In a separate press release, AstraZeneca announced that the FDA has expanded the label of its blockbuster cancer drug Calquence in 2017 for the first-line treatment of mantle cell lymphoma (MCL). The drug is now approved in combination with chemoimmunotherapy (bendamustine and rituximab) to treat adult patients with previously untreated MCL who are ineligible for autologous hematopoietic stem cell transplantation.
The above decision also converts the accelerated approval granted to Calquence in 2017 for adult patients with MCL treated with at least one prior therapy to a full one.
The FDA’s approval is based on data from the phase III ECHO study, which showed that treatment with Calquence-chemoimmunotherapy combo reduced the risk of disease progression or death by 27% compared to chemoimmunotherapy alone in the above indication.
AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold).
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Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Erasca ERAS. While CSTL and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ERAS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bottom-line estimates for Castle Biosciences have improved from a loss of 8 cents per share to earnings of 34 cents for 2024 in the past 60 days. During the same timeframe, loss per share estimates for 2025 have narrowed from $1.88 to $1.84. In the past year, shares of Castle Biosciences have surged 26%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 13 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 46 cents to 35 cents during the same timeframe. CTMX’s shares have lost 49% in the past year.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 60 days, estimates for Erasca’s 2024 loss per share have improved from 76 cents to 73 cents. Estimates for 2025 loss per share have narrowed from 64 cents to 61 cents during the same timeframe. In the past year, Erasca’s shares have risen nearly 6%.
ERAS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 7.04%.
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