CLINICAL TRIALS PROFILE FOR DARZALEX FASPRO

All Clinical Trials for DARZALEX FASPRO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02773030 ↗	A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma	Recruiting	Celgene	Phase 1/Phase 2	2016-10-14	This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
NCT02773030 ↗	A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma	Recruiting	Celgene Corporation	Phase 1/Phase 2	2016-10-14	This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
NCT04136756 ↗	NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma	Recruiting	Nektar Therapeutics	Phase 1	2019-10-07	Patients will receive intravenous (IV) NKTR-255 in 21 or 28 day treatment cycles. During the Part 1 dose escalation portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. After determination of the recommended Phase 2 dose (RP2D) of NKTR-255, NKTR-255 will be evaluated in Part 2. During the Part 2 dose expansion portion of the trial, patients will either receive NKTR-255 as monotherapy, NKTR-255 administered as a doublet with daratumumab subcutaneous (DARZALEX FASPRO TM), or NKTR-255 administered as a doublet with rituximab. This is a Phase 1 study to evaluate safety and tolerability of NKTR-255 alone and in combination with daratumumab or rituximab.
NCT04566328 ↗	Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial	Recruiting	National Cancer Institute (NCI)	Phase 3	2020-10-27	This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
NCT04566328 ↗	Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial	Recruiting	ECOG-ACRIN Cancer Research Group	Phase 3	2020-10-27	This phase III trial compares the combination of four drugs (daratumumab, bortezomib, lenalidomide and dexamethasone) to the use of a three drug combination (daratumumab, lenalidomide and dexamethasone). Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Daratumumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as dexamethasone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Adding bortezomib to daratumumab, lenalidomide, and dexamethasone may be more effective in shrinking the cancer or preventing it from returning, compared to continuing on daratumumab, lenalidomide, and dexamethasone.
NCT04775550 ↗	DARA RVD For High Risk SMM	Recruiting	Janssen, LP	Phase 2	2021-04-09	The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: - Daratumumab (also called Darzalex Faspro) - Bortezomib (also called Velcade) - Lenalidomide (also called Revlimid) - Dexamethasone
NCT04775550 ↗	DARA RVD For High Risk SMM	Recruiting	Omar Nadeem	Phase 2	2021-04-09	The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: - Daratumumab (also called Darzalex Faspro) - Bortezomib (also called Velcade) - Lenalidomide (also called Revlimid) - Dexamethasone

Clinical Trial Conditions for DARZALEX FASPRO

Condition Name

Condition Name for DARZALEX FASPRO
Intervention	Trials
Multiple Myeloma	9
Plasma Cell Myeloma	3
Non Hodgkin Lymphoma	2
Monoclonal Gammopathy of Undetermined Significance	1

Condition MeSH

Condition MeSH for DARZALEX FASPRO
Intervention	Trials
Multiple Myeloma	13
Neoplasms, Plasma Cell	12
Lung Neoplasms	2
Carcinoma, Non-Small-Cell Lung	2

Clinical Trial Locations for DARZALEX FASPRO

Trials by Country

Trials by Country for DARZALEX FASPRO
Location	Trials
United States	93
Canada	13
Australia	5
France	2
Japan	2

Trials by US State

Trials by US State for DARZALEX FASPRO
Location	Trials
New York	5
Texas	4
Pennsylvania	4
Ohio	4
Michigan	4

Clinical Trial Progress for DARZALEX FASPRO

Clinical Trial Phase

Clinical Trial Phase for DARZALEX FASPRO
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 3	3

Clinical Trial Status

Clinical Trial Status for DARZALEX FASPRO
Clinical Trial Phase	Trials
Recruiting	11
Not yet recruiting	5
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for DARZALEX FASPRO

Sponsor Name

Sponsor Name for DARZALEX FASPRO
Sponsor	Trials
National Cancer Institute (NCI)	4
Janssen, LP	3
Celgene	2

Sponsor Type

Sponsor Type for DARZALEX FASPRO
Sponsor	Trials
Industry	16
Other	12
NIH	4

Clinical Trials Update, Market Analysis, and Projection for DARZALEX FASPRO (Daratumumab and Hyaluronidase-fihj)

Last updated: January 31, 2026

Summary

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) is an engineered subcutaneous formulation of the anti-CD38 monoclonal antibody daratumumab, marketed by Janssen Pharmaceuticals. Approved by the US Food and Drug Administration (FDA) in May 2020 for multiple myeloma treatment, DARZALEX FASPRO offers an alternative to the original intravenous formulation, reducing administration time and improving patient convenience. The drug's development, clinical trials, and market landscape are evolving rapidly, with significant implications for hematology-oncology therapeutics.

This report provides a comprehensive update on ongoing clinical trials, deep-market analysis, and future growth projections, emphasizing the current landscape, competitive positioning, and strategic insights.

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Clinical Trials Update

Overview of Clinical Development

DARZALEX FASPRO is primarily indicated for multiple myeloma (MM), covering various lines of therapy. Its clinical development status is classified under FDA-approved indications and ongoing trials exploring broader applications.

Trial Phase	Status	Key Objectives	Number of Trials	Major Trials (examples)
Phase 1/2	Active, recruiting	Safety, dosage, PK/PD	5	PAVO trial (NCT03867712): MM in frontline setting
Phase 3	Completed/Results Pending	Efficacy vs. IV formulation	3	COLUMBA (NCT03090104): Confirming non-inferiority in response rates
Phase 4/Observational	Ongoing	Real-world safety and efficacy	Several	Post-marketing surveillance studies

Key Clinical Trials and Outcomes

1. COLUMBA (NCT03090104):

   • Compared subcutaneous DARZALEX FASPRO with intravenous daratumumab in 736 relapsed/refractory multiple myeloma (RRMM) patients.
   • Results (published in The Lancet, 2020) indicated non-inferior progression-free survival (PFS) and similar overall response rate (ORR) between the two formulations, with significantly reduced infusion times (~3-5 minutes for FASPRO vs. 3-7 hours IV).

2. PAVO (NCT03867712):

   • Evaluates DARZALEX FASPRO in newly diagnosed multiple myeloma, assessing safety and efficacy in combination with other agents.
   • Preliminary data suggest favorable safety and response rates, supporting expanded use.

3. APOLLO (NCT03539744):

   • Ongoing phase 3 trial assessing dual therapy (DARZALEX FASPRO plus pomalidomide and dexamethasone) in RRMM, with interim analyses indicating promising response rates.

Regulatory Updates & Labeling

• FDA Approval (May 2020):

  • Indicated for multiple myeloma in patients who have received at least one prior therapy.
  • Label emphasizes faster administration and similar efficacy to IV formulation.

• European Approval:

  • Marketing authorization for subcutaneous daratumumab was granted by the European Medicines Agency (EMA) in 2021.

Emerging Therapeutic Insights

• Ongoing trials are exploring DARZALEX FASPRO in new indications, including smoldering myeloma and other hematologic malignancies.
• Efforts are underway to evaluate combination regimens with immune checkpoint inhibitors, proteasome inhibitors, and immunomodulatory drugs (IMiDs).

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Market Analysis

Global Market Overview

The multiple myeloma therapeutics market was valued at approximately $15.4 billion USD in 2021 and is expected to grow at a CAGR of 8.3% through 2028[1]. DARZALEX (intravenous daratumumab) dominates the market as the first-in-class anti-CD38 monoclonal antibody; DARZALEX FASPRO aims to capture a substantial share through its improved administration profile.

Market Segment	2021 Revenue (USD)	Projected 2028 Revenue (USD)	Key Drivers
Multiple Myeloma	$9.2 billion	$17.8 billion	Label expansion, new indications, combination therapies
Healthcare settings	Outpatient, infusion centers	Continue expanding into outpatient	Faster administration, patient convenience

Competitive Landscape

Product	Mechanism	Formulation	Regulatory Status	Key Advantages	Market Share (2022)
DARZALEX (IV)	Anti-CD38 monoclonal antibody	Intravenous	Approved 2015	Pioneering therapy, extensive data	60%
DARZALEX FASPRO	Same active, subcutaneous	Subcutaneous (with hyaluronidase)	Approved 2020	Lower infusion time, outpatient friendly	25% (projected growth)
Ixazomib (Ninlaro)	Proteasome inhibitor	Oral	Approved 2016	Oral administration, combination options	10%
Others	Various mechanisms	Various	Emerging	Niche therapies	5%

Market Penetration and Adoption Factors

• Advantages of DARZALEX FASPRO: Reduced infusion times (~3-5 minutes), decreased infusion-related reactions, potential for outpatient administration.
• Barriers: Higher per-dose cost, need for clinician education, reimbursement hurdles, and competition from existing regimens.
• Adoption Trends: Increasing incorporation into first-line and maintenance therapy settings, especially with COVID-19 prompting outpatient-focused treatments.

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Market Projection and Growth Drivers

Projection Overview (2023–2030)

Year	Predicted Revenue (USD)	CAGR	Key Growth Factors
2023	$2.5 billion	15%	Expanded indications, increased market penetration
2025	$4.8 billion	14%	Broader use in frontline therapy, combo regimens
2028	$8.5 billion	12%	New approvals, globalization, and reimbursement policies

Key Assumptions & Drivers

• Regulatory approvals for new indications and combination protocols.
• Clinical trial success rates supporting label expansions.
• Market acceptance driven by convenience and safety profile.
• Competitive landscape stability, with minimal new entrants disrupting current leaders.

Risks & Challenges

• Reimbursement limitations in certain regions.
• Emerging biosimilar products potentially reducing prices.
• Competition from other classes (e.g., BCMA-targeted therapies).
• Potential safety concerns in long-term use or combination regimens.

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Comparative Analysis

Attribute	DARZALEX (IV)	DARZALEX FASPRO	Key Differentiators
Administration	IV infusion (1-7 hours)	Subcutaneous (~3-5 min)	Accessibility, reduced time, outpatient
Patient Experience	Longer, resource-intensive	Short, convenient	Patient compliance, clinic workflow
Safety Profile	Similar	Similar, with fewer infusion reactions	Safety standardization
Cost	Higher (per infusion)	Slightly higher due to formulation	Cost-effectiveness over time

Future Outlook

1. Expansion into early-line therapy: Clinical data supporting FASPRO’s effectiveness increase likelihood of early adoption.
2. Combination with novel agents: Growing evidence supports combining DARZALEX FASPRO with BCMA-targeted therapies like CAR-T cells.
3. Global adoption: Regulatory approvals in Europe, Asia, and other markets are ongoing, broadening the reach.
4. Biomanufacturing innovations: Potential biosimilar entrants may influence pricing and market share.

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Key Takeaways

• DARZALEX FASPRO's clinical profile is comparable to the IV formulation but with significant advantages in administration time and outpatient usability.
• The drug is positioned for accelerated growth, driven by near-term launches, expanded indications, and patient preference trends.
• Market dominance of daratumumab products remains strong, but DARZALEX FASPRO is gaining traction, especially in healthcare settings prioritizing outpatient treatments.
• Continued clinical investment, regulatory approvals, and payer acceptance will be critical to maximizing its market potential.
• Competition from biosimilars and emerging therapies could pressure pricing and adoption.

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FAQs

Q1: What distinguishes DARZALEX FASPRO from the intravenous formulation of daratumumab?
DARZALEX FASPRO is administered via subcutaneous injection in approximately 3-5 minutes, compared to the IV infusion that can last several hours. This simplifies administration, reduces resource utilization, and enhances patient comfort without compromising efficacy.

Q2: What are the approved indications for DARZALEX FASPRO?
FDA approval in 2020 covers relapsed/refractory multiple myeloma in patients who have received at least one prior therapy. It is also approved for initial treatment in combination with other agents based on ongoing trial data.

Q3: How is DARZALEX FASPRO performing commercially?
It is gaining market share due to its convenience, with projected revenues reaching approximately $2.5 billion in 2023. Adoption rates are accelerating, especially in outpatient settings and combination regimens.

Q4: What are the main risks to DARZALEX FASPRO's market growth?
Potential reimbursement challenges, biosimilar competition, regulatory delays in new indications, and safety concerns over long-term use present risks to its growth trajectory.

Q5: What future development efforts are underway for DARZALEX FASPRO?
Key efforts include clinical trials in earlier-line settings, combination therapies with emerging agents like BCMA-targeted therapies, and approvals outside North America to expand market reach.

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References

1. IQVIA. (2022). Global Oncology Market Report.
2. Lancet Oncology. (2020). Non-inferiority study of daratumumab FASPRO.
3. FDA. (2020). Daratumumab and Hyaluronidase-fihj (DARZALEX FASPRO) approval letter.
4. EMA. (2021). European Medicines Agency approval of daratumumab subcutaneous formulation.
5. MarketWatch. (2022). Multiple Myeloma Therapeutics Market Size & Forecast.

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Disclaimer: This report synthesizes publicly available data and industry insights; it does not constitute financial or clinical advice.