4SC AG | MedPath

4SC's Resminostat (Kinselby) MAA for CTCL Treatment Advances Following EMA Review

5 months ago

• 4SC AG has submitted responses to the EMA's Day-120 questions for Resminostat (Kinselby) in treating cutaneous T-cell lymphoma (CTCL). • The EMA is continuing its review of the Marketing Authorisation Application (MAA) for Resminostat, with potential approval expected mid-2025. • Resminostat, an oral HDAC inhibitor, has shown statistically significant improvement in progression-free survival in CTCL patients. • The RESMAIN study demonstrated a 97.6% improvement in PFS compared to placebo, marking a significant step for this potential maintenance therapy.

4SC AG's Resminostat Faces EMA Review Amidst Financial Constraints

7 months ago

• 4SC AG has filed for marketing authorization of Resminostat with the EMA for advanced cutaneous T-cell lymphoma, marking a key regulatory milestone. • RESMAIN study data showed Resminostat significantly improved progression-free survival in CTCL patients, with a median PFS of 8.3 months compared to 4.2 months for placebo. • Despite positive clinical data and cost reductions, 4SC AG reported a loss of nearly EUR4 million in H1 2024 and will not pursue US registration based on FDA feedback. • The company is actively seeking commercialization partners in the EU and anticipates addressing EMA questions to refile its submission in late 2024.

4SC's Resminostat (Kinselby) MAA Under EMA Review for Advanced CTCL Maintenance Therapy

10 months ago

• 4SC AG's Marketing Authorization Application (MAA) for resminostat (Kinselby) is under evaluation by the European Medicines Agency (EMA) for advanced Cutaneous T-Cell Lymphoma (CTCL). • The MAA is based on positive data from the pivotal RESMAIN study, which demonstrated that resminostat prolongs progression-free survival in CTCL patients. • 4SC anticipates addressing the EMA's questions by the end of 2024, with potential EU market authorization expected by mid-2025, pending approval. • 4SC is actively exploring licensing opportunities for Kinselby in the EU, UK, and Switzerland, aiming to provide a maintenance therapy option for CTCL patients.

4SC Files for EMA Approval of Resminostat (Kinselby) for Advanced Cutaneous T-Cell Lymphoma

a year ago

• 4SC AG has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for resminostat (Kinselby). • The application is for the treatment of advanced-stage cutaneous T-cell lymphoma (CTCL) in patients who have achieved disease control with systemic therapy. • RESMAIN study data showed resminostat significantly improved progression-free survival (PFS) compared to placebo (8.3 vs. 4.2 months; p=0.015; HR: 0.623). • Resminostat is an oral histone deacetylase (HDAC) inhibitor with manageable and reversible side effects, offering a potential maintenance therapy for CTCL.

4SC AG Receives MHRA Waiver for Resminostat in Pediatric CTCL

a year ago

• 4SC AG secured a Paediatric Investigation Plan (PIP) waiver from the UK MHRA for resminostat (Kinselby) in advanced-stage cutaneous T-cell lymphoma (CTCL). • The waiver streamlines 4SC's Marketing Authorisation Application in the UK by eliminating the need for pediatric clinical trials, saving time and resources. • Resminostat, an oral maintenance treatment, is under review by the EMA, with filings in preparation for the UK and Switzerland, and a pre-NDA meeting request submitted to the FDA.

Resminostat Receives European Orphan Drug Designation for Cutaneous T-Cell Lymphoma

2 years ago

• Resminostat, developed by 4SC AG, has been granted Orphan Drug Designation by the EMA for treating cutaneous T-cell lymphoma (CTCL). • This designation provides 4SC with benefits such as protocol assistance, market exclusivity, and fee reductions in the European Union. • The RESMAIN trial demonstrated resminostat's efficacy in improving progression-free survival in advanced CTCL patients, showing a 38% risk reduction compared to placebo. • Resminostat has also received Orphan Drug Designation from the FDA, strengthening its potential for commercialization in major markets.

Resminostat Receives Orphan Drug Designations in US and EU for CTCL Treatment

2 years ago

• Resminostat (Kinselby), a histone deacetylase (HDAC) inhibitor developed by 4SC AG, has been granted Orphan Drug Designation (ODD) by the FDA for cutaneous T-cell lymphoma (CTCL). • The European Medicines Agency (EMA) has also granted Orphan Drug Designation to resminostat for the treatment of CTCL, providing 10 years of market exclusivity in the EU. • 4SC anticipates submitting a Marketing Authorisation Application (MAA) to the EU for Kinselby (resminostat) in Q1 2024, marking a significant step toward potential approval.

4SC's Resminostat Advances Towards European Market Approval for CTCL Maintenance Therapy

2 years ago

• The EMA has accepted 4SC's Letter of Intent to Submit a Marketing Authorization Application (MAA) for resminostat, marking a key regulatory step. • The EMA has also accepted 'Kinselby' as the trade name for resminostat, facilitating its potential commercialization in Europe. • Resminostat, if approved, would be the first HDAC inhibitor for CTCL maintenance therapy in Europe, addressing a significant unmet need. • 4SC anticipates submitting the MAA in Q1 2024, based on positive data from the pivotal RESMAIN study.

RESMAIN Study: Resminostat Shows Promise in Cutaneous T-Cell Lymphoma Maintenance

3 years ago

• The RESMAIN study, evaluating resminostat for maintenance treatment of advanced-stage cutaneous T-cell lymphoma (CTCL), is set to unblind in Q1 2023. • An independent Data Safety Monitoring Board (DSMB) has recommended the continuation of the RESMAIN study without modifications, indicating a positive safety profile. • The RESMAIN study is the largest prospective clinical trial evaluating maintenance therapy in advanced-stage CTCL, with over 200 patients enrolled across Europe and Japan. • Resminostat, an orally administered HDAC inhibitor, aims to prolong progression-free survival and improve the quality of life for CTCL patients who have achieved disease control.

RESMAIN Trial of Resminostat for CTCL Maintenance Continues After Positive Safety Review

5 years ago

• The Data Safety Monitoring Board (DSMB) recommended the RESMAIN study of resminostat continue without modifications after reviewing safety data from the first 150 patients. • The RESMAIN trial evaluates resminostat as a maintenance treatment for advanced-stage cutaneous T-cell lymphoma (CTCL) patients who have achieved disease control with prior systemic therapy. • Enrollment in the RESMAIN study has been increased to 190 patients to minimize the time to unblinding, with top-line results expected by mid-2021. • A Phase II study of resminostat in biliary tract cancer in Japan, conducted by Yakult Honsha, has been discontinued, with no financial impact on 4SC.

Resminostat Shows Promise in Advanced Cancers: Clinical Updates and Biomarker Identification

12 years ago

• Resminostat combined with FOLFIRI chemotherapy demonstrates a manageable safety profile and encouraging clinical activity in patients with advanced, KRAS-mutant colorectal cancer (CRC). • A Phase I study confirmed resminostat's tolerability up to 800 mg daily with FOLFIRI, showing disease stabilization in a subset of patients treated for extended periods. • Analysis of Phase II trials in liver cancer (HCC) and Hodgkin lymphoma (HL) suggests ZFP64 gene expression as a potential biomarker for resminostat treatment response. • Higher baseline ZFP64 expression levels correlated with increased clinical benefit and longer overall survival in HCC and HL patients treated with resminostat.