FYARRO holds strong market potential, particularly in treating rare and aggressive cancers like PEComa, where treatment options are limited. As the first FDA-approved therapy for advanced PEComa, it addresses a critical unmet need.
LAS VEGAS, April 17, 2025 /PRNewswire/ -- DelveInsight's "FYARRO Market Size, Forecast, and Market Insight Report" highlights the details around FYARRO, an mTOR inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of FYARRO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Whitehawk Therapeutics' FYARRO (sirolimus protein-bound/ABI-009) Overview
FYARRO (albumin-bound) is a targeted therapy approved for the treatment of adults with locally advanced unresectable or metastatic malignant PEComa. This medication is specifically designed to combat cancer by targeting abnormal growth signals in perivascular epithelioid cells, which multiply uncontrollably in advanced PEComa. By blocking a key pathway involved in tumor growth, FYARRO helps slow or stop the spread of cancer. Unlike traditional chemotherapy, FYARRO functions as a precision therapy.
What sets FYARRO apart from other mTOR inhibitors is its use of nanoparticle technology, which enhances drug delivery directly into tumors. This allows for a more effective shutdown of the mTOR signaling pathways that drive cancer progression.
FYARRO became commercially available in the United States in February 2022. As per the company's SEC filing for the quarter ending September 30, 2024, net product sales reached USD 7.2 million for the three months and USD 18.7 million over the nine months. In comparison, during the same periods in 2023, sales were USD 6 million and USD 18 million, respectively. The year-over-year growth in both the quarterly and year-to-date figures for 2024 was mainly driven by robust market demand.
In addition to its role in treating PEComa, AADI Biosciences is also evaluating FYARRO in two Phase II clinical trials for advanced or recurrent endometrioid-type endometrial cancer (EEC) and neuroendocrine tumors (NETs). While new patient enrollment has been paused by the company, dosing continues for previously enrolled patients, with the studies set to provide initial efficacy signals in the coming months. The ongoing development of FYARRO underscores the company's commitment to improving treatment options for challenging cancers and advancing therapeutic options in unmet medical needs.
Drug Name | FYARRO (sirolimus protein-bound/ABI-009) |
Molecule type | Small molecule complex with human albumin |
Developer | Whitehawk Therapeutics (formerly Aadi Bioscience) |
Primary Indication | PEComa (approved); evaluating in TSC1 and TSC2 alterations and advanced or recurrent EEC and NETs |
Mechanism of action | mTOR inhibitor |
Route of administration | Intravenous |
Learn more about FYARRO projected market size for PEComa @ FYARRO Market Potential
Perivascular epithelioid cell neoplasms (PEComas) are rare tumors of the soft tissues, typically developing around small blood vessels in organs such as the lungs, gastrointestinal tract, kidneys, liver, and uterus. According to the WHO classification, PEComa not otherwise specified (NOS) encompasses both benign forms and more aggressive, malignant variants. One of the more serious presentations commonly encountered in clinical practice is abdominopelvic perivascular epithelioid cell sarcoma, often referred to as malignant PEComa. In 2023, the number of new PEComa cases in the United States was estimated at around 250, with projections indicating a gradual increase through 2034.
Wide surgical resection remains the standard approach for localized PEComa, although there are no established guidelines for systemic therapy in such cases. While there has been a notable instance of an 80% tumor reduction with cytotoxic chemotherapy using doxorubicin and ifosfamide in a patient with extremity PEComa, most cases have shown limited benefit. Reports often document either disease progression during chemotherapy or residual tumor presence post-surgery. Limited data exist regarding the use of neoadjuvant radiation alone, but it may be approached similarly to other localized high-grade sarcomas. As with many other soft tissue sarcoma (STS) subtypes, the role of adjuvant chemotherapy remains uncertain. Most patients treated with adjuvant anthracycline-based regimens have experienced recurrence within a median follow-up of less than two years.
Approximately 20% of patients are diagnosed with metastatic disease at presentation, and around 70% of those with initially localized malignant PEComa eventually develop metastases. Despite the disease's unpredictable progression, some patients-especially those with isolated or oligometastatic lesions or long disease-free intervals-may benefit from surgical removal of metastases, potentially achieving prolonged remission and control. Conventional STS chemotherapies have generally shown minimal activity in advanced PEComa, with agents such as anthracyclines, ifosfamide, paclitaxel, gemcitabine, and dacarbazine failing to produce significant responses.
Discover more about the PEComa market in detail @ PEComa Market Report
Emerging Competitors of FYARRO
Currently, there is no emerging drug in the pipeline targeting PEComa. However, the PEComa Market Dynamics might change in the coming years owing to quicker diagnosis and improved awareness of the disease. Pricing policies must also be considered to achieve great success in PEComa; this will further help launch an attractive product appropriate to the market.
To know more about the number of competing drugs in development, visit @ FYARRO Market Positioning Compared to Other Drugs
Key Milestones of FYARRO
- In March 2025, Aadi Bioscience announced that it had changed its name to Whitehawk Therapeutics.
- In December 2024, Aadi Bioscience announced that it had agreed to sell its commercial drug product FYARRO to KAKEN Pharmaceutical for USD 100 million, an agreement to sell and issue USD 100 million of equity in a PIPE financing, and an exclusive license agreement for the development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics, a global Contract Research, Development and Manufacturing Organization, and Hangzhou DAC, a global leader in ADC innovation. And in March 2025, it was announced that the company's stockholders had approved the sale of FYARRO to KAKEN.
- In February 2022, Aadi launched FYARRO in the US for the treatment of advanced malignant PEComa. FYARRO is licensed to Aadi by Abraxis BioScience, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company (BMS).
Discover how FYARRO is shaping the PEComa treatment landscape @ FYARRO FDA Approval
FYARRO Market Dynamics
Surgical resection remains the primary treatment approach for localized PEComas. In advanced or metastatic settings, conventional chemotherapy and tyrosine kinase inhibitors have delivered modest results. However, mTOR inhibitors-especially FYARRO-have emerged as a promising therapy. FYARRO, the only FDA-approved treatment for advanced malignant PEComas, utilizes nanoparticle albumin-bound technology to deliver targeted action against tumors with elevated mTOR pathway activity, often linked to TSC1 or TSC2 mutations. In the pivotal AMPECT trial, FYARRO demonstrated an overall response rate (ORR) of 39%, a median duration of response (mDOR) of 39.7 months, and a median overall survival of 53.1 months, earning its place as the preferred treatment in NCCN guidelines.
Although FYARRO is central to current treatment strategies, other mTOR inhibitors-such as RAPAMUNE (sirolimus), AFINITOR (everolimus), and TORISEL (temsirolimus)-have shown clinical benefit despite not being specifically approved for PEComa. For example, everolimus has achieved sustained disease control in cases of metastatic small bowel PEComa. Additionally, the VEGFR inhibitor VOTRIENT (pazopanib) has been used off-label to reduce tumor vascularization, though its effectiveness is still under evaluation. Traditional sarcoma chemotherapies have generally shown limited benefit in PEComa, underscoring FYARRO's unique role.
Nevertheless, several unmet needs persist, including the need to better understand mechanisms of resistance, to develop more durable treatment options for advanced disease, and to identify reliable prognostic biomarkers for tailoring therapy. Advancing research and expanding clinical trial efforts into innovative targeted therapies could be key to overcoming these challenges.
Dive deeper to get more insight into FYARRO's strengths & weaknesses relative to competitors @ FYARRO Market Drug Report
Table of Contents
1 | Report Introduction |
2 | FYARRO: Whitehawk Therapeutics |
2.1 | Product Overview |
2.2 | Other Development Activities |
2.3 | Clinical Development |
2.4 | Clinical Trials Information |
2.5 | Safety and Efficacy |
2.6 | Product Profile |
2.7 | Market Assessment |
2.7.1 | The 7MM Analysis |
2.7.1.1 | Cost Assumptions and Rebate |
2.7.1.2 | Pricing Trends |
2.7.1.3 | Analogue Assessment |
2.7.1.4 | Launch Year and Therapy Uptake |
2.7.2 | The United States Market Analysis |
2.7.3 | EU4 and the United Kingdom Market Analysis |
2.7.3.1 | Germany |
2.7.3.2 | France |
2.7.3.3 | Italy |
2.7.3.4 | Spain |
2.7.3.5 | UK |
2.7.4 | Japan Market Analysis |
2.8 | Market Drivers |
2.9 | Market Barriers |
2.10 | SWOT Analysis |
3 | Key Cross of Marketed Competitors of FYARRO |
4 | Key Cross of Emerging Competitors of FYARRO |
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