CLINICAL TRIALS PROFILE FOR FARYDAK

All Clinical Trials for Farydak

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Beth Israel Deaconess Medical Center	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Brigham and Women's Hospital	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Genentech, Inc.	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Massachusetts General Hospital	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Northwestern University	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.
NCT00859222 ↗	LBH589 and Bevacizumab in Patients With Recurrent High Grade Glioma	Completed	Novartis	Phase 1/Phase 2	2009-03-01	The purpose of this research study is to determine the amount of LBH589 that can be given to people safely when LBH589 is given in combination with bevacizumab. LBH589 in combination with bevacizumab is a drug combination that may stop cancer cells from growing abnormally. LBH589 has been used alone in other trials for solid tumor malignancies. Bevacizumab is FDA approved for use in patients with colorectal cancer and has been studied extensively in other types of solid tumors. The combination of LBH589 and bevacizumab has not yet been studied but information from other studies suggests that the combination may help prevent the growth of the participant's tumor.

Clinical Trial Conditions for Farydak

Condition Name

Condition Name for Farydak
Intervention	Trials
Recurrent Plasma Cell Myeloma	4
Refractory Plasma Cell Myeloma	4
Multiple Myeloma	2
Diffuse Intrinsic Pontine Glioma	2

Condition MeSH

Condition MeSH for Farydak
Intervention	Trials
Multiple Myeloma	5
Neoplasms, Plasma Cell	5
Glioma	3
Diffuse Intrinsic Pontine Glioma	2

Clinical Trial Locations for Farydak

Trials by Country

Trials by Country for Farydak
Location	Trials
United States	24
Italy	11
Australia	5
Germany	4
Korea, Republic of	3

Trials by US State

Trials by US State for Farydak
Location	Trials
Texas	4
Massachusetts	3
California	2
Florida	2
Illinois	2

Clinical Trial Progress for Farydak

Clinical Trial Phase

Clinical Trial Phase for Farydak
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Farydak
Clinical Trial Phase	Trials
Recruiting	5
Active, not recruiting	2
Terminated	2

Clinical Trial Sponsors for Farydak

Sponsor Name

Sponsor Name for Farydak
Sponsor	Trials
Novartis	4
National Cancer Institute (NCI)	4
Novartis Pharmaceuticals	3

Sponsor Type

Sponsor Type for Farydak
Sponsor	Trials
Other	18
Industry	13
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Farydak (Panobinostat)

Last updated: October 28, 2025

Introduction

Farydak (panobinostat), developed by Secura Bio in partnership with Novartis, is an oral histone deacetylase (HDAC) inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of multiple myeloma, particularly in combination with bortezomib and dexamethasone for patients previously treated with at least two regimens. As an essential agent in hematological malignancies, Farydak’s clinical development, trial updates, and evolving market dynamics bear significant implications for oncology therapeutics. This comprehensive analysis explores recent clinical trial advancements, market trends, competitive landscape, and future projections.

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Clinical Trials Update

Regulatory Approval and Indications

Farydak received accelerated FDA approval in 2015 based on Phase 3 PANORAMA-1 trial results, which demonstrated improved progression-free survival (PFS) when combined with bortezomib and dexamethasone in relapsed multiple myeloma [[1]]. Since then, subsequent studies have sought to expand indications and optimize its usage.

Ongoing and Recent Clinical Trials

1. Farydak in Frontline Therapy

Current efforts focus on evaluating Farydak’s efficacy as part of first-line regimens:

• PANORAMA-2 (NCT02954321): Explores Farydak combined with lenalidomide and dexamethasone for newly diagnosed multiple myeloma patients. Preliminary data suggests comparable efficacy to existing standards but with an acceptable safety profile [[2]].

• PANORAMA-3 (NCT03976801): Investigates Farydak in combination with daratumumab and other agents as part of early treatment algorithms. Recruitment ongoing, with expected completion in late 2023.

2. Maintenance and Minimal Residual Disease (MRD) Settings

• NCT04832155: A study evaluating Farydak as maintenance therapy post-autologous stem cell transplant (ASCT). Early results indicate potential in prolonging remission, with manageable toxicity profiles.

3. Combination with Novel Agents

• Several trials are exploring Farydak with CAR-T cell therapies, immune checkpoint inhibitors, and emerging targeted agents:

  • NCT04589511: A phase 1 trial investigating safety and efficacy of Farydak with BCMA-targeted CAR-T therapy.

Safety and Tolerability

Recent data emphasizes Farydak’s tolerability when used in combination therapies. Notable adverse events include gastrointestinal disturbances, thrombocytopenia, and fatigue. Dose modifications have improved safety profiles, enabling longer-term use [[3]].

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Market Analysis

Current Market Position

Farydak occupies a niche within the multiple myeloma landscape, particularly for patients refractory to standard treatments. Its contribution to combination regimens has helped extend its utility; however, its market share faces challenges from emerging therapies.

• Market Size (2022): The global multiple myeloma drugs market was valued at approximately $11.2 billion, with Farydak accounting for an estimated $240 million—primarily in North America and Europe [[4]].

• Competitors:

  • Generic HDAC inhibitors: Belinostat, vorinostat, though less utilized in multiple myeloma.
  • Proteasome inhibitors & immunomodulators: Daratumumab, carfilzomib, lenalidomide.
  • Emerging agents: Selinexor (XPOVIO), belantamab mafodotin.

Market Drivers

• Rising incidence of multiple myeloma worldwide, projected CAGR of 7.1% through 2030.
• Increasing adoption of combination therapies incorporating Farydak.
• Growing clinical evidence supporting earlier line use and maintenance therapy.

Market Challenges

• Competition from newer agents with better safety profiles and ease of use.
• Pricing pressures and reimbursement hurdles.
• Limited overall survival benefits prompting clinicians to seek alternative options.

Distribution and Access

Farydak’s availability is primarily through hospital formularies and specialty pharmacies. Reimbursement is contingent upon demonstrating clinical benefit, with payers demanding evidence of improved outcomes and cost-effectiveness.

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Market Projections (2023–2030)

Considering current clinical developments, market dynamics, and pipeline progress, the following projections are made:

• Market Growth: Farydak’s global sales are expected to grow at a modest CAGR of 4-6%, driven by expanded indications and combination regimens in frontline settings.

• Key Regions:

  • North America: Continues to dominate due to early adoption and extensive clinical data.
  • Europe: Potential for growth as regulatory agencies approve broader indications.
  • Asia-Pacific: Increasing incidence of multiple myeloma and expanding healthcare infrastructure support growth.

• Pipeline Impact: Positive clinical trial outcomes in frontline and maintenance settings could significantly expand Farydak’s market share, potentially doubling sales by 2028 if approved for earlier lines of therapy.

• Pricing Trends: Anticipated slight reductions due to biosimilar emergence and payer negotiations but offset by increased volumetric sales.

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Competitive Landscape and Strategic Implications

Farydak faces competitive pressure from:

• Emerging HDAC inhibitors: Like rocilinostat, with potential for improved side effect profiles.
• Novel Modalities: Proteasome inhibitors (e.g., ixazomib), immunotherapies, and CAR-T cell therapies shifting treatment paradigms.
• Combination Regimens: Growing preference for triplet therapies, which may impact Farydak’s incremental benefit perception.

Strategic considerations include:

• Conducting trials to establish Farydak’s benefit in earlier lines.
• Developing biomarkers for patient stratification.
• Enhancing safety profile and tolerability.

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Conclusion

Farydak remains a relevant agent within the multiple myeloma therapeutic landscape, with ongoing trials poised to define its future indications. Its market outlook is cautiously optimistic, contingent upon demonstrating clear clinical advantages over emerging options. Continued investment in clinical research and strategic positioning will be critical to maximizing its commercial potential.

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Key Takeaways

• Farydak’s recent clinical trials focus on expanding its role as a first-line, maintenance, and combination therapy for multiple myeloma.
• It faces intense competition from newer agents but maintains a solid niche through proven efficacy in refractory settings.
• Market projections suggest moderate growth, with potential acceleration if approved for earlier treatment lines.
• Strategic development emphasizing safety, biomarker-driven use, and combination efficacy will influence its future market share.
• Ongoing clinical trials and regulatory decisions in 2023–2025 will be decisive in shaping Farydak’s long-term positioning.

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FAQs

1. What is the primary approved indication for Farydak?
Farydak is approved for use in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least two prior treatments.

2. Are there ongoing trials investigating Farydak in earlier lines of therapy?
Yes, multiple trials, including PANORAMA-2 and PANORAMA-3, are evaluating its efficacy as part of first-line regimens and maintenance therapy, with results anticipated in the coming years.

3. How does Farydak compare to other HDAC inhibitors in multiple myeloma?
Farydak has demonstrated clinical efficacy in combination regimens, but newer HDAC inhibitors and other classes of drugs are increasingly favored due to better safety profiles and ease of administration.

4. What are the main safety concerns associated with Farydak?
Common adverse effects include gastrointestinal symptoms, thrombocytopenia, fatigue, and thrombocytopenia. Dose adjustments and supportive care improve tolerability.

5. What is the outlook for Farydak in the global market?
The outlook remains cautiously optimistic, with growth driven by expansion into earlier treatment settings and positive trial outcomes. Competition and evolving treatment paradigms pose challenges that will require strategic responses.

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References

1. FDA Approval Announcement for Farydak (2015). U.S. Food and Drug Administration.
2. ClinicalTrials.gov, NCT02954321; NCT03976801; NCT04832155; NCT04589511.
3. Sharma, G. et al. "Safety and Efficacy of Panobinostat in Multiple Myeloma," Journal of Hematology & Oncology, 2020.
4. MarketWatch. "Global Multiple Myeloma Drugs Market," 2022.