Ana Vallejo, Author at Myeloma Patients Europe

MPE webinar: Long-term outcomes of CAR T-cell therapy in myeloma

Ana Vallejo — Thu, 01 Oct 2026 16:08:21 +0000

Chimeric antigen receptor (CAR) T-cell therapy is a treatment that uses genetically modified immune cells (T-cells) to treat myeloma. While clinical studies have demonstrated the strong efficacy of CAR T-cell therapies in this disease, many patients experience side effects that can persist for months or years after treatment.

To inform myeloma patients and the myeloma community about the long-term benefits and side effects of CAR T-cell therapies, Myeloma Patients Europe (MPE) will host the webinar on “Long-term outcomes of CAR T-cell therapy in myeloma” on Wednesday, 21 October at 16:00 CEST.

During this webinar you will hear about the long-term efficacy and safety data from clinical trials of CAR T-cell therapies in myeloma, and what recovery, long term monitoring and side-effect management may look like. This presentation will be given by Dr. Herman Einsele, from the University of Würzburg in Germany, who is a myeloma expert with extensive experience in CAR T-cell therapies.

You will also hear from David Williams, a myeloma patient and Myeloma UK (MUK) member, who received CAR T-cell therapy three years ago. David will share his experiences, including preparation, outcomes, side effects, and quality of life.

The two presentations will be followed by a Q&A session, during which you will have the opportunity to ask both speakers your questions.

Whether you are a patient, a carer or a patient advocate, this webinar will help you stay informed and better understand myeloma CAR T-cell therapy and its long-term outcomes.

Should you be unable to attend the webinar, please feel free to send your questions in advance to info@mpeurope.org and we will make sure they reach our speakers. A recording of the webinar will be available shortly after the session. Keep an eye out for our social media profiles! We look forward to your participation.

Meet our speakers

Dr. Herman Einsele is Full Professor of Internal Medicine and Director of the Department of Internal Medicine II, University Hospital Würzburg, Germany since 2004. Since 2018, he is the chair of the Specialized Working Group on Immune Therapies for Hematologic Disorders of the European Hematology Association (EHA).

Dr. Einsele is an expert in the field of myeloma with focus on CAR T-cell therapy, bispecific antibodies, adoptive immunotherapy and stem cell transplantation.

David Williams is a myeloma patient and part of the MPE member organisation Myeloma UK (MUK). He was diagnosed with myeloma in October 2022 and was admitted on the sponsored CAR T-cell therapy clinical trial called CARTITUDE. He has been in remission since October 2023.

David is almost retired and lives with his wife in Bristol, UK. He has a daughter and son and four grandchildren. Learn more about David’s story here.

The post MPE webinar: Long-term outcomes of CAR T-cell therapy in myeloma appeared first on Myeloma Patients Europe.

EMA committee recommends melflufen label expansion to third-line myeloma treatment

Ana Vallejo — Tue, 22 Sep 2026 08:00:40 +0000

On September 17, 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended extending the approved use of melphalan flufenamide (melflufen, Pepaxti®) to third-line myeloma treatment.

The CHMP is the European Medicines Agency’s (EMA) committee responsible for evaluating medicines and making recommendations on whether they should be approved for use in the European Union (EU). A positive recommendation from the CHMP still requires formal approval by the European Commission before it can be implemented, a process that typically takes a few months.

Melflufen is a medicine called a peptide drug conjugate. It is designed to deliver the active chemotherapy agent melphalan into myeloma cells, where it helps damage and kill them.

The CHMP recommendation would allow melflufen, in combination with dexamethasone, to be used in myeloma patients who have received at least two prior lines of therapy and whose disease is refractory to lenalidomide and their last line of treatment.

Melflufen is currently authorised in the EU for myeloma patients who have received at least three prior lines and whose disease is refractory to a proteasome inhibitor (e.g. bortezomib or carfilzomib), an immunomodulatory agent (e.g. lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (e.g. daratumumab or isatuximab).

The recommendation is based on data from the phase 3 OCEAN trial. This study showed that melflufen plus dexamethasone delayed myeloma progression compared with pomalidomide plus dexamethasone, although it did not significantly improve overall survival in the overall trial population.

If approved, this would provide another treatment option for third-line myeloma patients in the EU. Following European Commission approval, treatment availability will depend on pricing, reimbursement and access decisions in individual European countries.

The post EMA committee recommends melflufen label expansion to third-line myeloma treatment appeared first on Myeloma Patients Europe.

EMA committee recommends teclistamab plus daratumumab for relapsed or refractory multiple myeloma

Ana Vallejo — Fri, 03 Jul 2026 12:28:59 +0000

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the approved use of teclistamab (Tecvayli®) to include its use in combination with daratumumab for adults with relapsed or refractory myeloma who have received at least one prior therapy.

The CHMP is the European Medicines Agency’s (EMA) committee responsible for evaluating medicines and making recommendations on whether they should be approved for use in the European Union. A positive recommendation from the CHMP still requires formal approval by the European Commission before it can be implemented, a process that typically takes a few months.

Teclistamab is a bispecific antibody that helps the immune system recognise and destroy myeloma cells.

The CHMP recommendation is based on the results of the phase III MajesTEC-3 study, published in the New England Journal of Medicine. The study showed that patients treated with the combination of teclistamab and daratumumab lived longer without their myeloma getting worse compared with those receiving standard treatment. Watch below a patient-friendly video explaining the study, its results and its implications for clinical practice.

If approved, this would be the first authorised treatment combination in the European Union to combine a bispecific antibody with daratumumab for the treatment of myeloma.

Following any European Commission approval, availability will also depend on national assessment, pricing and reimbursement decisions in individual European countries.

The post EMA committee recommends teclistamab plus daratumumab for relapsed or refractory multiple myeloma appeared first on Myeloma Patients Europe.

European Commission approves subcutaneous isatuximab for the treatment of multiple myeloma

Ana Vallejo — Tue, 09 Jun 2026 14:37:08 +0000

On 8 June 2026, the European Commission approved the subcutaneous (under the skin) formulation of isatuximab (Sarclisa®) for use in all myeloma indications currently approved for the intravenous (IV) formulation of isatuximab.

The newly approved subcutaneous formulation can be administered as a subcutaneous injection or using the CirCLIQ® on-body injector. This makes it the first anticancer treatment approved in the European Union to be delivered via an on-body injector.

The CirCLIQ® on-body injector is a small, single use wearable device that automatically delivers isatuximab under the skin over a short period of time. The device is designed to allow treatment administration in outpatient settings and, where permitted, at home, potentially reducing the amount of time patients spend in hospital receiving treatment.

This approval follows the favourable recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2026, following the positive results of the IRAKLIA phase 3 study and additional supporting studies. The CHMP is the EMA committee responsible for assessing medicines and making recommendations about whether they should be approved for use.

Isatuximab is a type of targeted cancer treatment called a monoclonal antibody. It works by attaching to the CD38 protein found on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells.

Isatuximab is currently approved in the European Union in combination with:

bortezomib, lenalidomide and dexamethasone (referred to as Isa-VRd) for transplant-eligible and transplant-ineligible newly diagnosed myeloma patients
pomalidomide and dexamethasone (referred to as Isa-Pd) for myeloma patients who have received at least two prior therapies, including treatment with lenalidomide and a proteasome inhibitor (such as bortezomib)
carfilzomib and dexamethasone (referred to as Isa-Kd) for myeloma patients who have received at least one prior therapy.

Availability of the subcutaneous formulation will depend on the company’s marketing plans and, in some countries, further national assessments, pricing and reimbursement decisions.

The post European Commission approves subcutaneous isatuximab for the treatment of multiple myeloma appeared first on Myeloma Patients Europe.

New ways to administer daratumumab and isatuximab get positive recommendations from EMA

Ana Vallejo — Fri, 10 Apr 2026 07:40:20 +0000

At the end of March, the Committee for Medicinal Products for Human Use (CHMP) announced two positive recommendations for new ways of administering the existing myeloma drugs daratumumab and isatuximab.

Both drugs are monoclonal antibodies used in the treatment of myeloma. Both CHMP recommendations focus on subcutaneous injection, where a medication is injected into the fatty tissue layer between the skin and muscle.

The CHMP is the European Medicines Agency’s (EMA) body responsible for evaluating, authorising, and monitoring human medicines in the EU. A positive recommendation from the CHMP still needs the official approval of the European Commission to be implemented, a process which typically takes around a few months.

The first CHMP decision enables subcutaneous daratumumab (Darzalex®) to be administered at home by patients or carers. The first four doses need to be administered in hospital by a patient or their carer under the supervision of their healthcare professional. After undergoing proper training, the fifth dose can be administered at home by a patient or carer if their healthcare professional considers that it is appropriate.

This applies to all current authorised uses of subcutaneous daratumumab.

For isatuximab (Sarclisa®), the CHMP recommended that the medicine could be administered as a subcutaneous injection and as a subcutaneous injection through an on-body injector. The on-body injector is a device designed to deliver the medicine with the push of a button and would be the first myeloma medicine delivered this way. Both the subcutaneous injection and on-body injector delivery are done in hospital settings. Isatuximab is currently approved to be administered through intravenous infusion.

If approved, these recommendations will provide patients with more flexible options for the administration of daratumumab and isatuximab.

The post New ways to administer daratumumab and isatuximab get positive recommendations from EMA appeared first on Myeloma Patients Europe.

Join our webinar “The generics market in Europe and implications for cancer treatment and care”

Ana Vallejo — Thu, 05 Mar 2026 11:00:39 +0000

Myeloma Patients Europe (MPE) will hold a webinar on the generics market in Europe and implications for cancer treatment and care on Monday 30th March from 17:00 – 18:30 CET.

A generic medicine has the same active ingredient as a branded medicine and can be produced after the patent for the branded medicine expires. For example, Revlimid, a “backbone” treatment in myeloma, recently became generic and is marketed by a range of companies under the generic name lenalidomide. Generic medicines are often a lot cheaper than the branded product.

Generics offer opportunities for cost savings for public budgets and increased access to treatments for patients. At the same time, generics face a lot of challenges such as intense price competition between companies, which can lead manufacturers to withdraw products, or supply chain vulnerabilities.

This webinar will give the audience a lay introduction into generics and the generics market in Europe. This will be followed by three case studies presented by patient organisations with a focus in Central and Eastern Europe (CEE) which will focus on challenges and opportunities accessing generics from the patient point of view. The webinar will close with a panel discussion with the presenters on opportunities and challenges in the access of generic medication. During this panel discussion, the audience will have the opportunity to ask questions to the panellists.

How does the generics market operate in Europe? Radluca Radu, Associate Director, Pharmaceutical Policy, Medicines for Europe.

Industry perspective on challenges and opportunities in access to generics. Arnaud Maheas, Chair of the Generic Market Access Committee at Medicines for Europe & Head Global Policy and Public Affairs Europe, Sandoz.

Case study: Access to generic medicines in Poland. Carita Foundation, Poland.

Case study: Patient advocacy and generics in Croatia and Bosnia. Mira Armour, Chief Executive, MijelomCRO.

Presentation: Case study: Advocacy and access to generics in Chronic Myeloid Leukaemia (CML) in CEE. Jelena Cugurovic, Chair of the CML Advocates Network Steering Committee and CML Association of Serbia.

The post Join our webinar “The generics market in Europe and implications for cancer treatment and care” appeared first on Myeloma Patients Europe.

AELCLÉS presents report highlighting the high socioeconomic impact of oncohaematological diseases in Spain

Ana Vallejo — Thu, 19 Feb 2026 17:00:54 +0000

More than 65 per cent of people living with an oncohaematological disease experience a deterioration in their employment and financial situation. This is one of the key findings of a report developed and presented by AELCLÉS, one of the Spanish members of Myeloma Patients Europe (MPE).

According to the report, over 65 per cent of respondents stated that their professional situation worsened after their diagnosis. Applications for disability benefits are also frequent, exceeding 45 per cent among people living with myeloma.

The economic impact is another central focus of the report. More than two-thirds of participants (over 66 per cent) reported a worsening of their financial situation following their illness, particularly in cases of leukaemia and lymphoma. In some specific diseases, the percentage is even higher: 82.6 per cent for chronic leukaemia, 78.9 per cent for acute lymphoblastic leukaemia, 75 per cent for Hodgkin lymphoma and 70 per cent for non-Hodgkin lymphoma.

This financial strain is linked not only to reduced income, but also to significant additional monthly expenses related to the disease and its treatment.

Based on these findings, AELCLÉS proposes concrete measures across the labour, economic, social and institutional spheres. These include facilitating reintegration into the workforce through effective workplace adaptations, strengthening financial support and recognising illness-related expenses, providing adequate support for carers and ensuring comprehensive care that also addresses the social needs of patients and their families.

Myeloma and AL amyloidosis working group

In addition to presenting the report, the AELCLÉS myeloma and AL amyloidosis workgroup organised a round table discussion moderated by the MPE Head of Communications, Ana Vallejo.

This workgroup, created with the support of the MPE Scholarship and Capacity Building Programme, met to identify unmet needs of people living with myeloma and AL amyloidosis and to discuss possible solutions.

Beyond clinical challenges, participants highlighted the significant impact these diseases have on social and family life, as well as the uncertainty patients face about the future. This uncertainty is not only related to their health, but also to their employment situation and long-term financial stability.

The post AELCLÉS presents report highlighting the high socioeconomic impact of oncohaematological diseases in Spain appeared first on Myeloma Patients Europe.

MPE response to EMA consultation on their “Reflection paper on patient experience data (PED)”

Ana Vallejo — Tue, 03 Feb 2026 14:55:41 +0000

Last week Myeloma Patients Europe (MPE) submitted a response to the European Medicines Agency (EMA) open consultation on their “Reflection paper on patient experience data (PED)”. PED refers to data from patients that includes their perspectives, preferences and experiences with different aspects of their disease and treatments, such as quality of life and risk tolerability,

You can read the MPE full response to the consultation here.

MPE, as a member of the EMA Patient and Consumers Working Party (PCWP) and as an organisation regularly involved in EMA activities and assessments, welcomed the opportunity to comment on this paper. The declared purpose of the document is to “encourage systematic consideration of PED in medicine development programmes and regulatory submissions” by setting up general principles on the use of PED, as well as main types and main sources of such data.

While MPE appreciated the paper for bringing PED into focus as part of a wider effort to have patient involvement in medicine regulation as an active, meaningful, and holistic process, it also identified a series of recommendations to strengthen these efforts:

More clarity is needed on how PED can and should be used in EMA decision making.
A stronger emphasis is needed on the importance of PED to EMA decision-making and stronger language incentivising industry to generate and utilise this data.
The reflection paper should better address the challenges brought by the new EMA and EUHTA approaches to conflicts of interest (CoI).
We would like to see clearer avenues set out on how patient groups seek advice from EMA on PED, how we submit it, what the EMA want to see from patient organisations and how it could be taken into account.
Specific guidance is needed on how carers are and should be included in PED.
Clearer examples and best practice case studies are missing from the text and should be highlighted.

The comments received during this public consultation will be reviewed by the EMA and the final version will be adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Medicinal Products for Human Use (CHMP).

Another consultation currently open at the EMA concerns Patient Preference Studies (PPS) and the value that patients place on characteristics of drugs. The consultation will be open until 12 April 2026. MPE intends to respond to this as well.

Please see the full text of the comments submitted by the MPE on the PED guidelines.

If you have any comments please message info@mpeurope.org.

The post MPE response to EMA consultation on their “Reflection paper on patient experience data (PED)” appeared first on Myeloma Patients Europe.

US Food and Drug Administration (FDA) issues draft guidance on minimal residual disease

Ana Vallejo — Wed, 28 Jan 2026 14:30:54 +0000

The US Food and Drug Administration (FDA) has issued draft guidance to the pharmaceutical industry on using minimal residual disease (MRD) and complete response (CR) in myeloma clinical trials as a primary endpoint, to support approval under accelerated assessment.

This follows a previous decision of the US FDA’s Oncology Drugs Advisory Committee (ODAC) to accept MRD as an “intermediate endpoint” in accelerated approval. You can read MPE’s Q&A on the ODAC decision here.

A primary endpoint is the main outcome measured in a clinical trial to determine whether a treatment has worked. Up until now, most FDA assessments have been based on clinical trial data using primary endpoints such as overall survival (OS) (i.e. how long patients live after treatment) and progression free survival (PFS) (i.e. the length of time until the disease progresses after treatment). The ODAC decision and the draft FDA guidance mean that myeloma drugs may be approved earlier in the US based on clinical trial data measuring MRD and CR, which take less time to collect than survival measures.

What is CR and MRD?

Complete response (CR), including stringent complete response (SCR), is where myeloma cannot be detected in blood and urine tests or in the bone marrow after treatment. It is used to highlight the depth of response that patients have to treatment.

Minimal Residual Disease (MRD) is a very sensitive test and marker of treatment response in myeloma. It is a lot more sensitive than conventional tests for treatment response and can pick up one myeloma cell in one million normal cells. Patients may either be MRD positive or MRD negative following testing – with MRD negativity indicating a very deep response to treatment. If this deep response is maintained over time, with repeat MRD testing, the idea is that on average patients will have longer periods of remission (PFS) and overall survival (OS).

Both MRD and CR are used to understand how well a patient has responded to treatment. Evidence suggests that if patients achieve and sustain a CR or MRD-negativity, they will on average have longer periods of remission (PFS) and OS. Therefore, by measuring MRD and CR in clinical trials, decision-makers can approve treatments earlier instead of waiting for the PFS and OS data to become available.

What does the FDA guidance say?

The guidance highlights how MRD and CR can and should be used in myeloma clinical trials being designed for regulatory approval under the accelerated assessment process. This includes how industry should justify their choice of endpoint and how they analyse the results. You can view the full guidance here.

Whilst it sets out the use of these endpoints, it also clearly states the need for industry to continue measuring PFS and OS to “confirm” the results of data submitted for accelerated approval.

What is accelerated approval?

The FDA assess the safety, efficacy and clinical benefit of new drugs in the US. In serious diseases with an unmet medical need, such as myeloma, the FDA may use an accelerated approval process. Under this approach, the FDA can consider earlier indicators of treatment benefit, such as MRD, instead of waiting for long-term outcomes. This process is intended to allow for the earlier assessment of new drugs and therefore earlier access, as it can take a long time (10-15 years) to bring new drugs to market.

You can read more about accelerated approval here.

In the case of MRD and CR, pharmaceutical companies can now submit MRD data in support of accelerated approval applications and the FDA will consider this within their assessments. The draft guidance sets out the rules industry should follow when generating this data.

What happens next and does it impact in Europe?

The FDA has set out draft guidance for a period of consultation until 23 March 2026. MPE will follow the discussions around the consultation with interest.

Whilst the US FDA decision does not apply in Europe, there might be indirect implications as all new drug applications typically go through both the FDA and the European Medicines Agency (EMA) around the same time and are assessed using similar data to judge whether treatments are safe, effective and beneficial to patients.

MPE is continually working with our regulatory, research and industry partners to understand the implications of these decisions in Europe.

The post US Food and Drug Administration (FDA) issues draft guidance on minimal residual disease appeared first on Myeloma Patients Europe.

ASH 2025 summary video interviews

Ana Vallejo — Fri, 12 Dec 2025 12:19:14 +0000

The largest haematology meeting in the world has just finished. The American Society of Hematology (ASH) Annual Congress took place in Orlando, Florida, US, where the latest research in blood diseases was presented. Myeloma Patients Europe (MPE) interviewed key experts to learn more about the most relevant studies and abstracts in myeloma and AL amyloidosis.

Watch these interviews to learn what the most important updates were in myeloma and AL amyloidosis and why these results matter for people living with these conditions. Click on the thumbnails to watch.

On behalf of Myeloma Patients Europe, Prof. Dr. Hermann Einsele, shares his key myeloma highlights of the ASH 2025 conference.

Prof. Dr. Einsele is hematologist, oncologist, Professor of Internal Medicine and Director of the Department of Internal Medicine II at the University Hospital Würzburg in Germany. He is a world leading expert in the field of myeloma and immunotherapy and in particular CAR T-cells and bispecific antibodies.

He emphasised that the myeloma treatment landscape has never evolved as rapidly as today and we thank him for his encouraging words and his professional and insightful presentation.

Dr. Charlotte Pawlyn – Majestec-3

Dr. Charlotte Pawlyn from The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, UK, explains the main results of MajesTEC-3, one of the most important myeloma studies. This trial compared the combination of teclistamab and daratumumab (Tec-Dara) versus daratumumab with either pomalidomide or bortezomib and dexamethasone in patients who had received one to three previous lines of treatment. The Tec-Dara combination showed unprecedented benefits when used earlier in the myeloma pathway.

Dr. Phoebe Joy Ho – inMMyCAR

Dr. Phoebe Joy Ho from the Royal Prince Alfred Hospital and the University of Sydney, Australia, explains the results of inMMyCAR. This first-in-human study of KLN1010, a novel “in vivo” CAR T-cell therapy targeting BCMA, showed very good responses in four treated patients with no serious instances of cytokine release syndrome (CRS) or neurotoxicity (ICANs).

Dr. Bruno Paiva – GEM-CESAR

Dr. Bruno Paiva, Clínica Universidad de Navarra, Madrid, Spain, explains the main results of the GEM-CESAR clinical trial presented at ASH 2025. This a study assessing early rescue treatment with daratumumab, pomalidomide and dexamethasone (DPd) in people with high-risk smoldering myeloma.

Dr. Shambavi Richard – DURGA-1

Dr. Shambavi Richard, Icahn School of Medicine at Mount Sinai, New York, United States, explains the main results of the DURGA-1 trial evaluating AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy using FasTCAR technology for rapid manufacturing. Early data showed promise for this dual-target approach in relapsed/refractory multiple myeloma patients.

Dr. Xavier Leleu – LINKER-MM4

Dr. Xavier Leleu, Centre Hospitalier Universitaire de Poitiers, France, explains the main results of the LINKER-MM4 clinical trial which evaluates safety and efficacy of linvoseltamab as a simplified monotherapy in first-line regimen in newly diagnosed myeloma patients.

Dr. Charlotte Pawlyn – UK MRA FiTNESS trial

Dr. Charlotte Pawlyn, from The Royal Marsden NHS Foundation Trust and the Institute of Cancer Research, London, UK, explains the main results of the MRA FiTNESS trial, which aims to understand whether the International Myeloma Working Group (IMWG) frailty score can be used to tailor treatment according to a myeloma patient’s level of fitness.

Dr. Phoebe Joy Ho – CAMMA-3

Dr. Phoebe Joy Ho, Royal Prince Alfred Hospital and University of Sydney, Australia, explains the first results from the phase Ib CAMMA-3 study, in which subcutaneous cevostamab shows manageable safety and meaningful clinical activity in relapsed/refractory myeloma (RRMM).

Dr. Dominik Dytfeld – COBRA trial

Dr. Dominik Dytfeld, Poznan University of Medical Sciences, Poland, lead author of the COBRA trial, explains this study evaluating carfilzomib, lenalidomide and dexamethasone (KRd) versus bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma (NDMM).

Dr. Bruno Pavia – NoMoreMGUS

Dr. Bruno Paiva, Clínica Universidad de Navarra, Madrid, Spain, explains the main results of the NoMore MGUS clinical trials, one of the largest MGUS (Monoclonal Gammopathy of Undetermined Significance) data collection trials in the world.

Dr. Salomon Manier – IFM2021-01 trial

Dr.Salomon Manier, University of Lille, France, talks through this teclistamab trial. This study shows that an “all-antibody–based” doublet regimen of teclistamab and daratumumab is highly effective and well-tolerated in elderly newly diagnosed myeloma patients.

Dr. Paolo Milani – AL amyloidosis highlights

Dr. Paolo Milani, University of Pavia, Italy, explains for MPE the most important AL amyloidosis updates presented at ASH 2025, as well as the role of the CAR T-cell therapy in this disease or the main challenges AL amyloidosis is facing to improve treatment outcomes.

The post ASH 2025 summary video interviews appeared first on Myeloma Patients Europe.