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Resminostat's approval by the EMA (and the FDA, MHRA and more): How ...

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

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.

Repotrectinib Recommended for EU Approval in ROS1+ NSCLC and NTRK+ Solid Tumors

The EMA's CHMP recommended repotrectinib for adult patients with advanced ROS1-positive NSCLC, addressing the unmet need for new therapies in this population.
Repotrectinib is also recommended for NTRK fusion-positive solid tumors in adult and pediatric patients (12+), particularly after prior NTRK inhibitor treatment.

European Agency Signals Approval for Keytruda as First-Line Mesothelioma Treatment

The European Medicine Agency's CHMP has recommended Keytruda for first-line treatment of epithelioid malignant pleural mesothelioma in adults.
This endorsement mirrors the FDA approval of Keytruda plus pemetrexed and platinum-based chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma.

Pembrolizumab Plus Chemotherapy Receives Positive CHMP Opinion for Non-Epithelioid Mesothelioma

The European Committee for Medicinal Products for Human Use (CHMP) supports approving pembrolizumab plus pemetrexed and platinum-based chemotherapy for unresectable non-epithelioid malignant pleural mesothelioma (MPM).
The positive opinion is based on the KEYNOTE-483 trial, which demonstrated an overall survival benefit with pembrolizumab/chemotherapy compared to chemotherapy alone.

Immatics' IMA203 Demonstrates Promising Efficacy and Safety in Melanoma Phase 1 Trial

Immatics' ACTengine IMA203 TCR-T therapy shows a confirmed objective response rate exceeding 50% in heavily pretreated melanoma patients.
The therapy exhibits a manageable safety profile, with mostly mild to moderate cytopenias and cytokine release syndrome reported.

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

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.

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

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.

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

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

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.

Teclistamab Shows Promise in Heavily Pretreated Multiple Myeloma

In the MajesTEC-1 trial, teclistamab demonstrated a nearly two-thirds partial response rate in patients with relapsed or refractory multiple myeloma.
The median progression-free survival with teclistamab was approximately 11 months, with responses lasting a median of 18 months in heavily pretreated patients.

Reference News

[1]
Resminostat's approval by the EMA (and the FDA, MHRA and more): How ...
everyone.org · May 28, 2024

Resminostat, a treatment for advanced cutaneous T-cell lymphoma (CTCL), shows promise in clinical trials with significan...

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