CLINICAL TRIALS PROFILE FOR REVLIMID

505(b)(2) Clinical Trials for REVLIMID

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	Celgene Corporation	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	University of Wisconsin, Madison	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.

All Clinical Trials for REVLIMID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00056160 ↗	CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	Completed	Celgene	Phase 3	2003-01-01	Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
NCT00056160 ↗	CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	Completed	Celgene Corporation	Phase 3	2003-01-01	Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
NCT00067743 ↗	A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)	Completed	Celgene Corporation	Phase 2	2003-08-01	This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)

Clinical Trial Conditions for REVLIMID

Condition Name

Condition Name for REVLIMID
Intervention	Trials
Multiple Myeloma	144
Chronic Lymphocytic Leukemia	33
Plasma Cell Myeloma	26

Condition MeSH

Condition MeSH for REVLIMID
Intervention	Trials
Multiple Myeloma	233
Neoplasms, Plasma Cell	228
Lymphoma	141

Clinical Trial Locations for REVLIMID

Trials by Country

Trials by Country for REVLIMID
Location	Trials
Canada	135
France	77
Spain	68
Germany	67
Italy	64

Trials by US State

Trials by US State for REVLIMID
Location	Trials
Texas	117
California	112
New York	111
Ohio	91
Florida	83

Clinical Trial Progress for REVLIMID

Clinical Trial Phase

Clinical Trial Phase for REVLIMID
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	59
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for REVLIMID
Clinical Trial Phase	Trials
Completed	222
Active, not recruiting	97
Terminated	91

Clinical Trial Sponsors for REVLIMID

Sponsor Name

Sponsor Name for REVLIMID
Sponsor	Trials
Celgene Corporation	185
National Cancer Institute (NCI)	134
Celgene	105

Sponsor Type

Sponsor Type for REVLIMID
Sponsor	Trials
Other	529
Industry	486
NIH	137

REVLIMID Market Analysis and Financial Projection

Revlimid (Lenalidomide): Clinical Trials, Market Analysis, and Projections

Introduction to Revlimid

Revlimid, also known as lenalidomide, is a pivotal drug in the treatment of multiple myeloma, myelodysplastic syndromes, and certain types of lymphoma. Developed by Celgene, which is now part of Bristol Myers Squibb, Revlimid has been a cornerstone in cancer therapy for over a decade.

Clinical Trials Update

Current and Upcoming Trials

Revlimid continues to be a subject of extensive clinical research, with several ongoing and planned trials.

• Combination Therapies: The FDA has recently approved Revlimid in combination with rituximab (R² regimen) for the treatment of previously treated follicular lymphoma (FL) and marginal zone lymphoma (MZL). The Phase 3 AUGMENT trial demonstrated a median progression-free survival (PFS) of 39.4 months for patients treated with the R² regimen, compared to 14.1 months for those receiving rituximab plus placebo[3].

• New Celmod Molecules: Bristol Myers Squibb is advancing several "celmod" molecules, designed to replace Revlimid as its patents expire. These include iberdomide, mezigdomide, and golcadomide. For instance, the Golseek-1 study will enroll 850 front-line B-cell lymphoma patients to compare golcadomide plus R-Chop versus R-Chop alone[1].

• STAR-LLD by Starton Therapeutics: Starton Therapeutics is developing STAR-LLD, a continuous delivery lenalidomide formulation, which has shown lower toxicity and higher bioavailability compared to oral Revlimid. Phase 2 studies in multiple myeloma and chronic lymphocytic leukemia are planned for 2025[4].

Market Analysis

Current Market Size and Forecast

The global market for Revlimid was estimated to be worth $10,350 million in 2023. However, due to the expiration of patents and the introduction of generic versions, the market is forecast to decline to $6,006.3 million by 2030, with a CAGR of -5.2% during the period 2024-2030[2].

Lenalidomide Market Outlook

Despite the decline in the Revlimid market, the overall lenalidomide market is expected to grow. The global lenalidomide market is projected to reach $15.67 billion by 2032, growing at a CAGR of 4.7% during the forecast period. This growth is driven by the increasing incidence of blood cancers and the higher efficiency of lenalidomide in treating multiple myeloma, myelodysplastic syndromes, and lymphoma[5].

Competitive Landscape

The lenalidomide market is becoming more competitive with the entry of generic versions. Companies like Natco Pharma, Teva, and Sun Pharma are expanding their offerings in the lenalidomide market. For example, Sun Pharma received approval to market generic lenalidomide capsules in several strengths after entering into a settlement agreement with Celgene Corporation[5].

Regional and Segment Analysis

The lenalidomide market is segmented by type, application, end-user, dosage, and region. The increasing initiatives by pharmaceutical companies to expand their brand coverage and enhance the accessibility of medicine are likely to stimulate growth in various regions. The market report highlights the revenue forecasts for different segments, providing a detailed insight into current market dynamics and future growth[5].

Projections and Future Outlook

Expanding Indications

Revlimid's approval in combination with rituximab for previously treated follicular lymphoma and marginal zone lymphoma expands its use beyond multiple myeloma, reinforcing its role as a versatile cancer therapy[3].

Generic Competition

The introduction of generic lenalidomide is expected to increase the supply and reduce the cost of the drug, making it more accessible to patients. However, this also poses a challenge to the branded version of Revlimid, as generic competition is likely to erode its market share[2][5].

Next-Generation Celmods

Bristol Myers Squibb's development of next-generation celmod molecules like iberdomide, mezigdomide, and golcadomide aims to replace Revlimid in various disease settings. These molecules have higher potency and are optimized for different disease settings, which could maintain the company's market position despite the patent expiry of Revlimid[1].

Key Takeaways

• Clinical Trials: Revlimid continues to be part of significant clinical trials, including combination therapies and new indications.
• Market Decline: The Revlimid market is expected to decline due to patent expiry and generic competition.
• Lenalidomide Growth: The overall lenalidomide market is projected to grow driven by increasing cancer cases and higher efficiency in treatment.
• Competitive Landscape: The market is becoming more competitive with the entry of generic versions and next-generation celmod molecules.
• Expanding Indications: Revlimid's use is expanding beyond multiple myeloma, enhancing its role in cancer therapy.

FAQs

What is the current market size of Revlimid and its forecasted size by 2030?

The global market for Revlimid was estimated to be worth $10,350 million in 2023 and is forecast to decline to $6,006.3 million by 2030[2].

What are the new indications for Revlimid?

Revlimid has been approved in combination with rituximab for the treatment of previously treated follicular lymphoma and marginal zone lymphoma[3].

What are the next-generation celmod molecules being developed by Bristol Myers Squibb?

Bristol Myers Squibb is developing iberdomide, mezigdomide, and golcadomide as next-generation celmod molecules to replace Revlimid in various disease settings[1].

How does STAR-LLD by Starton Therapeutics differ from Revlimid?

STAR-LLD is a continuous delivery lenalidomide formulation that shows lower toxicity and higher bioavailability compared to oral Revlimid[4].

What is the projected growth of the global lenalidomide market by 2032?

The global lenalidomide market is expected to reach $15.67 billion by 2032, growing at a CAGR of 4.7% during the forecast period[5].

Sources

1. ApexOnco: Bristol's son of Revlimid goes pivotal.
2. Valuates Reports: Revlimid - Market size, worth, revenue, growth, industry.
3. BioSpace: Multiple Myeloma Market Size to Reach USD 38.1 Billion by 2034.
4. Starton Therapeutics: Announces 100% Partial Response or Better in Top-Line STAR-LLD Phase 1b Data.
5. Polaris Market Research: Lenalidomide Market Expects $15.67 Billion By 2032, CAGR: 4.7%.