MedPath
EMA Approval

Phelinun

L01AA03

melphalan

Antineoplastic agents

melphalan

Multiple MyelomaHodgkin DiseaseLymphoma, Non-HodgkinPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteNeuroblastomaOvarian NeoplasmsHematopoietic Stem Cell Transplantation

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeL01AA03
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Phelinun is a cancer medicine for treating patients with:

  • cancers of the bone marrow (which produces blood cells) – multiple myeloma, acute lymphoblastic leukaemia and acute myeloid leukaemia;
  • Hodgkin and non-Hodgkin lymphomas, which are cancers that affect white blood cells called lymphocytes;
  • Childhood neuroblastoma, a cancer of nerve cells in different parts of the body;
  • ovarian cancer;
  • mammary adenocarcinoma, a type of breast cancer.

It is used either on its own or in combination with other cancer medicines, or radiotherapy or both.

Phelinun can also be used for stem cell transplantation in adults and children with blood cancers and some other blood disorders in children. It is given with other cytotoxic (cell-killing) medicines for conditioning treatment (to clear cells in the bone marrow) before the patient receives healthy stem cells from a donor to replace the diseased cells.

Phelinun contains the active substance melphalan.

Phelinun is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Phelinun is intended for an additional use (conditioning treatment). The reference medicine for Phelinun is Alkeran 50 mg/10 ml, which is marketed in France.

Authorisations (1)

EMEA/H/C/005173

ADIENNE S.r.l. S.U.,Via Galileo Galilei, 19,20867 Caponago (MB),Italy

Authorised

November 16, 2020

Active Substances (1)

melphalan hydrochloride

Documents (8)

Phelinun : EPAR - Public assessment report

November 25, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Phelinun : EPAR - Medicine overview

November 25, 2020

OVERVIEW_DOCUMENT

Phelinun : EPAR - Risk-assessment-report summary

November 25, 2020

RISK_MANAGEMENT_PLAN_SUMMARY

CHMP summary of positive opinion for Phelinun

September 18, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Phelinun : EPAR - Public assessment report

November 25, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Phelinun : EPAR - Product information

November 25, 2020

DRUG_PRODUCT_INFORMATION

Phelinun : EPAR - All authorised presentations

November 25, 2020

AUTHORISED_PRESENTATIONS

Phelinun : EPAR - Procedural steps taken and scientific information after authorisation

November 24, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (7)

Question

How is Phelinun used?

Answer

Phelinun can only be obtained with a prescription and it must be given under the supervision of a doctor experienced in the use of cancer medicines and conditioning treatment for stem cell transplantation.

Phelinun is given by infusion (drip) into a vein and the dose depends on the condition it is being used for as well as the patient’s weight and height. The dose can be split and given over 2 or 3 consecutive days.

For more information about using Phelinun, see the package leaflet or contact your doctor or pharmacist.

Question

How does Phelinun work?

Answer

Melphalan, the active substance in Phelinun is a type of cytotoxic medicine known as alkylating agent. It prevents cells from dividing by stopping the DNA (the cell’s genetic material) from duplicating itself to form new cells. Melphalan’s action therefore affects cells that divide rapidly, such as cancer cells and cells of the bone marrow.

Question

What benefits of Phelinun have been shown in studies?

Answer

Studies on the benefits and risks of the active substance, melphalan, for the treatment of cancers have already been carried out with the reference medicine, Alkeran, and do not need to be repeated for Phelinun.

The company also provided evidence from over 20 published studies to show that melphalan is effective for conditioning treatment in adults and children undergoing haematopoietic (blood) stem cell transplantation.

As for every medicine, the company provided studies on the quality of Phelinun. There was no need for ‘bioequivalence’ studies to investigate whether Phelinun is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Phelinun is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

Question

What are the risks associated with Phelinun?

Answer

The most common side effects with Phelinun (which may affect more than 1 in 10 people) include reduced levels of blood cells and platelets (blood components involved in clotting), infections, gastrointestinal disorders (such as diarrhoea, vomiting, mouth ulcers and bleeding) and disorders of the immune system (the body’s natural defences) including graft-versus-host disease (transplanted cells attacking the body).

Phelinun must not be used during breast-feeding or as conditioning treatment during pregnancy.

For the full list of side effects and restrictions of Phelinun, see the package leaflet.

Question

Why is Phelinun authorised in the EU?

Answer

The European Medicines Agency concluded that, in accordance with EU requirements, Phelinun has been shown to be comparable to Alkeran for the treatment of blood cancers. Although main studies to measure the effectiveness of Phelinun for conditioning treatment in adults and children are not available, evidence from published studies shows that it is effective, and in some cases its side effects may be lower than those of other options for conditioning treatment.

The European Medicines Agency therefore decided that Phelinun’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Phelinun?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Phelinun have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Phelinun are continuously monitored. Side effects reported with Phelinun are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Phelinun

Answer

Phelinun received a marketing authorisation valid throughout the EU on 16 November 2020.

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