Somatic cell therapy continues under EMA review

5 September 2018
The European Medicines Agency (EMA) has published new information and updated procedural steps that have been taken since conditional market authorisation (given in 2016) for the advanced therapy medicine of Zalmoxis. Zalmoxis is a somatic cell therapy product that is used as an add-on treatment for adult lymphoma and leukaemia patients who have had an allogeneic stem cell transplant involving a partially-matched donor (known as a haploidentical transplant). Zalmoxis is used to help restore the immune system after transplant.

Zalmoxis involves removing the T-cells (a type of white blood cell or lymphocyte) from the transplant donor and genetically modifying them to include a “suicide gene”. It is given after transplant, but only if the patient’s immune system has not restored and graft-versus-host disease (GvHD) has not developed (i.e., when the transplanted cells attack the patient’s body).

In a study involving 30 haploidentical stem cell transplant patients 77% of the patients receiving Zalmoxis had their immune systems restored, with 10 of the patients developing GvHD which was successfully treated in all cases. Data from this study were also combined with data from a second ongoing study. Survival rates for 37 patients treated with Zalmoxis (23 from the first study and 14 from the latter) were compared with rates from a database of 140 patients who had previously undergone haploidentical transplant. The number of patients who survived after one year was 51% for those receiving Zalmoxis compared with 34 to 40% for those who did not. LEARN MORE


Carmustine receives market authorisation as a generic

September 2018
Following market authorisation in July 2018 of Carmustine Obvius, the European Medicines Agency has now published the treatment’s full product details, including the public assessment report. Carmustine Obvius is a generic version of carmustine which has been in medicinal use for more than 40 years and is a standard second-line treatment option in a wide number of indications/protocols, including BEAM (carmustine, etoposide, cytarabine, melphalan) (or in lower doses as mini-BEAM) as a conditioning regime for stem cell transplantation.

Carmustine has been available in European markets since 15 August 1998, however, according to the EMA, it has been on discontinuation in the EU since February 2014 for a number of reasons, most of which relate to manufacturing complexities with the active substance in the treatment. Netherlands-based company Obvius applied to the EMA claiming eligibility to the centralised procedure on the basis that it would address the shortage and impact an area of treatment need. LEARN MORE


Influencing European cancer care – ECCO consultation on new policy proposals

2 August 2018
ECCO, the European CanCer Organisation which represents 24 member societies and promotes multidisciplinarity and patient centricity in cancer care, is changing the way it runs its annual cancer congress. ECCO’s 2018 Cancer Summit, 7-9 September in Vienna, Austria, will be in the form of a policy summit bringing together leaders in the field of cancer policy to debate and finalise high level resolutions on the organisation and delivery of the best care to cancer patients in Europe. ECCO is inviting comments, responses and support from organisations and individuals. LEARN MORE


Brentuximab vedotin approved for skin lymphomas

22 January 2018
European Commission approves Brentuximab vedotin (trade name ADCETRIS®) for CD30-positive cutaneous T-cell lymphoma after one prior systemic therapy, an important milestone for the CTCL community in Europe. 


CAR T therapy for DLBCL granted accelerated access to marketing authorisation

17 January 2018
The European Medicines Agency (EMA) has granted an accelerated assessment to a marketing authorisation application for tisagenlecleucel (trade name Kymriah), for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This CAR T-cell therapy, previously called CTL019, will be approved for patients who have relapsed after a stem cell transplant or are not eligible for one.


Commission announces new models for healthcare system

24 July 2017
The European Commission announced it is preparing three opinions on pricing models for innovative medicines, access to healthcare and performance of primary care. These opinions will be ready in the second semester of 2017 and will feed into the further policy work of the Commission.


Obinutuzumab for follicular lymphoma has marketing authorisation extended

20 July 2017 
The EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending to extend the terms of the marketing authorisation for Gazyvaro. The new indication regards the treatment of patients with previously untreated advanced follicular lymphoma. 


New platform for industry to coordinate advice on pan-Europe HTA processes

4 July 2017
On 4 July, the EMA and the European Network for Health Technology Assessment (EUnetHTA) have launched a new joint platform to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. Patient representatives will be involved in parallel consultations on a routine basis so that their views and experiences can be incorporated into the discussions.


Second rituximab biosimilar approved

19 June 2017
The European Commission (EC) has approved Rixathon – a biosimilar of rituximab marketed by Sandoz GmbH – for use in all indications of the reference medicine. Rixathon is the second biosimilar of rituximab to receive a marketing authorisation in Europe after Truxima (Celltrion Healthcare) was approved by the EC in February 2017.


Belgian process for managed entry agreements (MEA)

31 May 2017
The Belgian Health Care Knowledge Center published a very informative report on the Belgian process for Managed Entry Agreements (MEA), which analyses both the Belgian and the European experience. MEA are alternative funding mechanisms aimed at enabling early access to pharmaceuticals, whose (cost-)effectiveness is still unknown or for which the budget impact is expected to be very high.

Orphan Drug Designation status granted to MRG-106 for cutaneous T-cell lymphoma


24 May 2017
EMA granted Orphan Drug Designation status to MRG-106 for the treatment of patients with Cutaneous T-Cell Lymphoma. The status is given to treatments for rare diseases. It accelerates the regulatory approval process and provides the therapies’ developers with incentives to keep working on them.


Positive recommendations for rituximab biosimilars

18 May 2017
The EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for three biosimilar versions of rituximab: Blitzima, Tuxella, and Ritemvia, all marketed by Celltrion Healthcare Hungary Kft. Blitzima and Tuxella are intended for the treatment of NHL and CLL, while Ritemvia is only intended for the treatment of NHL.


Strengthening of the EU cooperation on health technology assessments (HTA)

15 May 2017
On 15 May, the European Commission published the results of the online consultation on “Strengthening of the EU cooperation on Health Technology Assessment (HTA)”. Most patient organisations expressed their preference for a common clinical and economical evaluation of health technologies (full joint HTA). Based on the results of this consultation, the European Commission is now expected to present a legislative proposal on the future of EU cooperation on HTA.


Pembrolizumab (KEYTRUDA®) approved to treat R/R cHL

5 May 2017
Pembrolizumab (KEYTRUDA®) was approved by the European Commission (EC) to treat adult patients with R/R cHL who progressed after receiving ASCT and brentuximab vedotin (ADCETRIS®), or who are transplant-ineligible and have failed brentuximab vedotin.


Value of the NHS Cancer Drugs Fund (CDF)

27 April 2017
A study published on 27 April 2017 in the Annals of Oncology analyses the value delivered to society by the NHS Cancer Drugs Fund (CDF), which was established in 2010 to reduce delays and improve access to cancer drugs in England.


Positive recommendations for biosimilars of rituximab

21 April 2017
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for two biosimilar versions of rituximab: Rixathon and Riximyo, both marketed by Sandoz GmbH. While Rixathon is intended for the treatment of NHL and CLL, Riximyo is only intended for the treatment of NHL.


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