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Zalmoxis (Allogeneic T cells genetically modified...) – Conditions or restrictions regarding supply and use - L01

Updated on site: 11-Oct-2017

Medication nameZalmoxis
ATC CodeL01
SubstanceAllogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)
ManufacturerMolMed SpA

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

MolMed SpA Via Olgettina 58 20132

Milan

Italy

Name and address of the manufacturer responsible for batch release

MolMed SpA Via Olgettina 58 20132

Milan

Italy

B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic safety update reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

At the request of the European Medicines Agency;

Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being

reached.

Additional risk minimisation measures

Prior to launch of Zalmoxis in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials for the Health Care Professionals (HCPs), with the National Competent Authority.

The MAH shall ensure that in each Member State where Zalmoxis is marketed, all HCPs who are expected to prescribe, dispense, and administer Zalmoxis are provided with a guidance document containing the following key elements:

1. Relevant information about the safety concerns of Graft versus Host Disease (GvHD)

During and after treatment with Zalmoxis the physician must be aware of acute and chronic sign and symptoms of GvHD at any time and ensure that either ganciclovir or valganciclovir is available at ward for early treatment of GvHD.

If at any time during or after treatment with Zalmoxis an acute GvHD of grade equal to or greater than 2 or a chronic GvHD develop, the patient has to be treated with ganciclovir at a dose of 10 mg/kg/day divided into 2 administrations intravenously, or valganciclovir 900 mg two times per day orally for 14 days.

In case of GvHD progression after 3 days of treatment with ganciclovir or valganciclovir alone, a standard immunosuppressive therapy has to be added.

Zalmoxis should be administered after a 24-hour discontinuation period of ganciclovir or valganciclovir and immunosuppressive therapy.

2. Relevant information about the safety concern of Concomitant administration of Ganciclovir and Valganciclovir

The treating physician must ensure that patients do not receive ganciclovir or valganciclovir within 24 hours prior to the administration of Zalmoxis. A longer interval might apply in case of renal failure.

3. Relevant information about the safety concern of Concomitant immunosuppressive therapy

Patients should not be administered Zalmoxis in case of:

o Onset of GVHD requiring systemic immunosuppressive therapy

oOngoing systemic immunosuppressive therapy or administration of granulocyte colony stimulating factor (G-CSF) after haploidentical hematopoietic stem-cell transplantation

Patients could be treated with Zalmoxis 24 hours after the antiviral or immunosuppressive therapy discontinuation.

Zalmoxis shall not be administered to patients with concurrent systemic immunosuppressive therapy as the efficacy of Zalmoxis treatment in early immune reconstitution may be reduced. Immunosuppressive therapy also affects immunocompetent cells as such infused with Zalmoxis. An adequate wash-out period shall be applied prior to infusion of this medicinal product.

4. Remarks on the importance of reporting ADRs and encourage patients to be enrolled into study TK011 (linked with the EBMT registry)

5. A Detailed step-by step description of Zalmoxis administration procedure, also focusing on: o The room requirements for Zalmoxis administration

o Storage, transport and thawing of Zalmoxis bag

o Surveillance of Zalmoxis efficacy (Immune reconstitution - IR)

To monitor IR, the quantification analyses of CD3+ cells should be performed weekly during the first month after Zalmoxis administration. In absence of IR, an additional Zalmoxis dose has to be administered with an interval of 30 days up to a maximum number of four doses. In case of IR achievement, documented by two consecutive CD3+ cell counts ≥ 100/µL,Zalmo xis treatment has to be stopped.

Obligation to complete post-authorisation measures

Description

Due date

 

 

Non Interventional PASS: In order to investigate the safety and effectiveness in real

Q4 2022

clinical practice as well as long-term safety and effectiveness in all patients treated with

 

Zalmoxis, the MAH should conduct and submit the results of study TK011 using the

 

EBMT registry including all patients treated with Zalmoxis.

 

Progress updates should be submitted yearly with the annual renewal.

 

The clinical study report should be submitted by Q4 2022.

 

 

 

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE CONDITIONAL MARKETING AUTHORISATION

This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

 

 

The MAH shall complete, within the stated timeframe, the below measures:

March 2021

In order to confirm the efficacy and safety of Zalmoxis as an adjunctive treatment in

 

haploidentical haematopoietic stem-cell transplantation of adult patients with high-risk

 

haematological malignancies, the MAH should submit the results of study TK008, a

 

randomized phase III trial of haploidentical HCT with an add back strategy of HSV-Tk

 

donor lymphocytes in patients with high risk acute leukaemia.

 

In addition updates on recruitment should be submitted within the PSURs.

 

The clinical study report should be submitted by March 2021.

 

 

 

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