Kadcyla is owned by Roche Holding AG, a publicly traded Swiss pharmaceutical company. Roche trades on the SIX Swiss Exchange under ticker ROG and on OTCQX under RHHBY. Kadcyla was developed by Genentech, a Roche subsidiary based in South San Francisco, California. Genentech licensed ImmunoGen's DM1 technology in 2000 to create the drug.

Is Kadcyla publicly traded?

Kadcyla is not publicly traded as a separate entity. Parent company Roche Holding AG trades on the SIX Swiss Exchange under ROG and on OTCQX under RHHBY. Investors seeking exposure to Kadcyla must purchase Roche shares. Kadcyla's financial performance is reported as a product within Roche's Pharmaceuticals division results.

When was Kadcyla approved?

The FDA approved Kadcyla on February 22, 2013, for HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. In May 2019, the FDA approved Kadcyla for adjuvant treatment of HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy, based on the KATHERINE trial.

How does Kadcyla work?

Kadcyla is an antibody-drug conjugate. The trastuzumab component binds to HER2 receptors on cancer cells. The conjugate is then internalized into the cell, where the linker is cleaved and DM1 is released. DM1 inhibits microtubule polymerization, causing cancer cell death. This targeted delivery minimizes systemic toxicity compared to conventional chemotherapy.

How does Kadcyla compare to Enhertu?

The DESTINY-Breast03 trial showed that Enhertu (trastuzumab deruxtecan) significantly improved progression-free survival compared to Kadcyla as second-line therapy for HER2-positive metastatic breast cancer. Treatment guidelines now recommend Enhertu over Kadcyla in the metastatic second-line setting. However, Kadcyla remains the standard of care for adjuvant treatment of HER2-positive early breast cancer with residual disease, where Enhertu has not yet been approved.

What is ImmunoGen's role in Kadcyla?

ImmunoGen, Inc. developed the DM1 maytansinoid cytotoxic agent and linker technology used in Kadcyla. Genentech licensed the technology in 2000. ImmunoGen received royalties on Kadcyla sales. AbbVie acquired ImmunoGen in February 2024 for approximately $10.1 billion, but the royalty arrangement with Roche continues.

Healthcare & Pharmaceuticals

Who Owns Kadcyla?

Kadcyla (ado-trastuzumab emtansine) is owned by Roche Holding AG (SIX: ROG; OTCQX: RHHBY), a publicly traded Swiss pharmaceutical company headquartered in Basel, Switzerland. Kadcyla was developed by Genentech, a Roche subsidiary, using ImmunoGen's DM1 technology licensed in 2000. The FDA approved Kadcyla in 2013 for HER2-positive metastatic breast cancer and in 2019 for adjuvant early-stage treatment. Kadcyla generated CHF 2.03 billion in sales in 2025.

Parent Company

Roche

Founded

2013

Status

Publicly Traded

Headquarters

Basel, Switzerland

Kadcyla Timeline

1896

Roche

Parent company established in Basel, Switzerland

Company Founded

2013

Kadcyla

Founded by Genentech (developer; Roche subsidiary)

Founded

GlobalOfficial Website

Who Owns Kadcyla?

Parent Company: Roche
Ownership Type: Wholly owned
Company Type: Publicly Traded
Stock Ticker: SIX: ROG

Brand	Parent Company	Ownership Type
Kadcyla	Roche	Wholly owned

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Kadcyla on Amazon

History of Kadcyla

Founded: 2013
Founders: Genentech (developer; Roche subsidiary)

The concept behind Kadcyla originated from antibody-drug conjugate (ADC) research. The goal was to combine the HER2-targeting precision of trastuzumab (Herceptin) with a potent chemotherapy agent, delivering the cytotoxic payload directly to cancer cells while minimizing systemic toxicity.

ImmunoGen, Inc. developed DM1, a maytansinoid microtubule inhibitor derived from maytansine. DM1 is 100 to 1,000 times more potent than conventional chemotherapy agents but too toxic to administer systemically on its own. By conjugating DM1 to trastuzumab through a stable chemical linker, Genentech and ImmunoGen created a molecule that binds to HER2 receptors on cancer cells, is internalized, and releases DM1 inside the cell to kill it.

Genentech licensed ImmunoGen's TAP technology in 2000. The compound was designated T-DM1 during development. The pivotal Phase 3 EMILIA trial compared T-DM1 to lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. EMILIA demonstrated that T-DM1 significantly improved both progression-free survival and overall survival compared to the control arm.

The FDA approved Kadcyla on February 22, 2013, for HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. This approval established Kadcyla as the standard second-line treatment for metastatic HER2-positive breast cancer.

The Phase 3 KATHERINE trial expanded Kadcyla's indication. KATHERINE evaluated Kadcyla as adjuvant therapy in patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy. Kadcyla significantly reduced the risk of invasive disease recurrence or death compared to trastuzumab alone. Based on KATHERINE, the FDA approved Kadcyla for adjuvant treatment of HER2-positive early breast cancer with residual disease in May 2019.

The KATHERINE approval was commercially significant. The adjuvant early-stage setting represents a larger patient population than the metastatic setting. Kadcyla became the standard of care for HER2-positive early breast cancer patients with residual disease after neoadjuvant therapy.

Kadcyla's metastatic indication has been challenged by Enhertu (trastuzumab deruxtecan), developed by AstraZeneca and Daiichi Sankyo. The DESTINY-Breast03 Phase 3 trial demonstrated that Enhertu significantly improved progression-free survival compared to Kadcyla as second-line therapy for HER2-positive metastatic breast cancer. Oncology guidelines now recommend Enhertu over Kadcyla in the metastatic second-line setting. Kadcyla retains its standard-of-care position in the adjuvant setting based on KATHERINE.

Kadcyla sales grew steadily after the KATHERINE approval, reaching CHF 2.19 billion in 2023. Sales declined to CHF 2.03 billion in 2025, reflecting competitive displacement by Enhertu in the metastatic setting partially offset by continued use in the adjuvant setting.

About Roche

Roche operates through two main business divisions: Pharmaceuticals and Diagnostics, creating a unique integrated healthcare company that combines treatment and diagnostic capabilities. This dual focus enables Roche to deliver personalized healthcare solutions, matching patients with the most effective treatments based on diagnostic information and molecular characteristics.

The Pharmaceuticals division develops and manufactures prescription medicines across multiple therapeutic areas, with particular strength in oncology, immunology, neuroscience, infectious diseases, and rare diseases. Roche's pharmaceutical portfolio includes both established blockbuster products and innovative new treatments that address significant unmet medical needs. The division maintains a global research and development network with facilities across multiple continents, investing billions annually in pharmaceutical innovation, clinical trials, and regulatory approvals.

The Diagnostics division produces laboratory testing systems, molecular diagnostics, and point-of-care testing devices that support healthcare professionals in disease detection, monitoring, and treatment selection. Roche's diagnostic capabilities include automated laboratory systems, molecular testing platforms, and digital health solutions. The division's integrated approach with pharmaceuticals creates unique advantages in personalized medicine, enabling precise treatment selection based on diagnostic information.

Roche's business philosophy emphasizes innovation, patient-centricity, and sustainable value creation. The company maintains a strong focus on research and development, with approximately 20% of pharmaceutical revenues invested in R&D activities. This investment supports a robust pipeline of new treatments and diagnostic solutions, with 10 key molecules advancing into phase III development in 2025 alone.

Financial performance in 2025 demonstrated the strength of Roche's integrated business model. The company reported 7% sales growth at constant exchange rates to CHF 61.5 billion, with the Pharmaceuticals Division achieving 9% growth and the Diagnostics Division growing 2%. Core operating profit increased by 13%, reflecting operational efficiency and strong demand for both pharmaceutical and diagnostic solutions.

Key growth drivers in 2025 included Phesgo for breast cancer, Xolair for food allergies, Ocrevus for multiple sclerosis, Hemlibra for hemophilia A, and Vabysmo for severe eye diseases. These products demonstrate Roche's strength across multiple therapeutic areas and its ability to deliver innovative treatments that address significant patient needs.

Looking toward 2026, Roche expects Group sales growth in the mid single digit range and core earnings per share growth in the high single digit range at constant exchange rates. The company plans to further increase its dividend to CHF 9.80 per share, which would mark the 39th consecutive dividend increase if approved by shareholders. For 2026, Roche is shifting focus from consolidation to optimization, emphasizing internal pipeline development and R&D process improvements to enhance productivity and decision-making.

Roche's strategic priorities include investing in programs with potential to redefine care standards, particularly in oncology, neuroscience, and immunology. The company maintains a $10 billion annual budget for potential acquisitions and partnerships, prioritizing strategic fit and scientific differentiation over transaction size. This approach reflects Roche's commitment to long-term value creation and sustainable growth while maintaining operational discipline.

Founded: 1896
Headquarters: Basel, Switzerland
Company Type: Publicly Traded
Stock: SIX: ROG
Revenue: CHF 61.5 billion (FY2025)
Employees: Approximately 101,000

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Where Is Kadcyla Made / Based?

Headquarters: Basel, Switzerland
Manufacturing / Operations: United States, Switzerland, Germany

Kadcyla Categories & Tags

Oncology Breast Cancer Her2 Antibody Drug Conjugate Roche

Kadcyla Sustainability & Ethics

Kadcyla is manufactured under Roche's environmental, social, and governance framework. Roche has committed to achieving net-zero greenhouse gas emissions by 2040, with interim targets for 2030. Kadcyla production facilities in the United States, Switzerland, and Germany are included in Roche's carbon reduction strategy.

Kadcyla does not hold independent sustainability certifications. The drug's environmental impact is reported as part of Roche's consolidated sustainability reporting, not separately verified for the Kadcyla product.

Roche publishes an annual Sustainability Report detailing progress against environmental and social goals. The report is verified by third-party auditors for greenhouse gas emissions data.

Kadcyla Recalls & Controversies

Kadcyla has not been subject to product recalls. The drug has maintained a consistent safety record since its 2013 approval. However, several issues have affected the brand:

Enhertu competitive displacement is the most significant challenge. The DESTINY-Breast03 trial demonstrated that Enhertu significantly improved progression-free survival compared to Kadcyla as second-line therapy for HER2-positive metastatic breast cancer. Oncology guidelines now recommend Enhertu over Kadcyla in the metastatic second-line setting, reducing Kadcyla's use and contributing to the sales decline from CHF 2.19 billion in 2023 to CHF 2.03 billion in 2025.

Kadcyla's high cost has generated controversy regarding patient access. Annual treatment costs exceeding $100,000 in the United States create barriers for patients without adequate insurance coverage. Patient advocacy groups and healthcare payers have criticized the pricing, particularly in markets with limited reimbursement.

Kadcyla carries known risks of serious side effects including thrombocytopenia, hepatotoxicity, peripheral neuropathy, and cardiotoxicity. These side effects require careful patient monitoring and can necessitate dose reductions or treatment discontinuation. The FDA label includes boxed warnings for hepatotoxicity and cardiac dysfunction.

The complex ADC manufacturing process creates supply chain challenges. Production requires specialized facilities for handling potent cytotoxic compounds, limiting the number of manufacturing sites that can produce Kadcyla. Any disruption at these facilities could affect supply.

Kadcyla Ownership: Pros & Cons

Advantages

+Standard of care for adjuvant HER2-positive early breast cancer with residual disease, a large patient population
+First FDA-approved antibody-drug conjugate for HER2-positive breast cancer with over a decade of clinical use
+ADC mechanism provides patent protection that biosimilars cannot easily replicate
+Roche's global commercial infrastructure and oncologist relationships support market presence
+Strong evidence base from EMILIA and KATHERINE Phase 3 trials

Considerations

-Enhertu has displaced Kadcyla in the metastatic second-line setting per treatment guidelines
-Annual treatment costs exceeding $100,000 create access barriers and draw pricing criticism
-Complex ADC manufacturing limits production sites and creates supply chain vulnerability
-Serious side effects including hepatotoxicity and cardiotoxicity require careful monitoring
-Sales declining from CHF 2.19 billion in 2023 to CHF 2.03 billion in 2025

Frequently Asked Questions About Kadcyla

Sources & Further Reading

Competitors to Kadcyla

These competing brands operate in the same categories and provide similar products or services. Compare key attributes to understand market positioning and competitive landscape.

Brand	Parent Company	Country	Founded	Market Position	Primary Market	Gender Target
HerceptinSister Brand	Roche	USA (Genentech)	1998	Premium	Global	All-ages
PerjetaSister Brand	Roche	USA (Genentech)	2012	Premium	Global	Womens
Adcetris	Pfizer	United States	2011	Mass market	North america	All Genders
Taxotere	Sanofi	France	1996	Established	Global	Unisex
XelodaSister Brand	Roche	USA (Genentech)	1998	Mass market	Global	All Genders