(Adnkronos) - L’ematologa Barbui: ‘con tabelecleucel 84% pazienti vivi a un anno’. Soffientini (Pierre Fabre): ‘orgogliosi di rimborso”. Conferma impegno quarantennale in oncoematologia.
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00:00The Italian Pharmaceutical Agency has granted reimbursement to the first allogenic cell therapy
00:11specific to the Epstein-Barr virus or EBV, obtained by health donors for the monotherapy treatment
00:18of patients of two or more years of age with PTLD, acronym for post-treatment proliferative lymphoma disease,
00:25positive to the Epstein-Barr virus, recidivate or refractory, which have already been subjected at least to a PTLD therapy.
00:34But what is PTLD, correlated to the Epstein-Barr virus?
00:38The hematologist Anna Maria Barbui explains it to us,
00:41responsible for the De Hospital of Hematology of the Papa Giovanni XXIII Territorial Social Health Company in Bergamo.
00:48PTLD are rare hematological complications that can occur after transplantation of a solid organ
00:55or after transplantation of hematopoietic stem cells.
00:59The first-line therapy uses immunotherapy alone in combination with chemotherapy
01:06and can produce very good results in a good percentage of patients.
01:12Unfortunately, there is a subgroup of patients who do not respond to this first-line therapy
01:17and for whom, unfortunately, the average life expectancy is less than six months.
01:22For these people with post-treatment PTLD, positive to the Epstein-Barr virus,
01:27of which 90-95% of the world's population is infected, today there is a big news.
01:33There is the possibility of using a new therapeutic strategy, which is called Tabelec-Leucel.
01:40This therapy is a new therapy because it is based on the use of ant-EBV cytotoxic lymphocytes
01:50that are obtained by healthy donors.
01:53These cells are able to recognize the cells of the disease
01:57that have integrated the Epstein-Barr virus and analyze them.
02:01The authorization of AIFA is based on the results of the study at the EVE
02:05published last year on the onset oncology,
02:08but what are the most significant data emerged from this trial?
02:12It was possible, with the use of this cellular product,
02:16to obtain a comprehensive response of 51% of cases
02:21and with an average, also here, of the general population, of survival of 18.4 months.
02:32If, on the other hand, we do the analysis on the group of patients who had a response,
02:38in one year we see that more than 84% of these patients are still alive.
02:44So the news brought by this new therapy for PTLD,
02:49related to the Epstein-Barr virus, are different.
02:52It is not a chemotherapy, but a cellular therapy.
02:56It is a therapy ready for use,
02:59so we can take advantage of this therapy in a fairly rapid way.
03:06It is a therapy that is administered in hospitals,
03:11so it does not require the recovery of the patient,
03:14and then it is a therapy that is extremely well tolerated.
03:18So even this population of patients, which is particularly fragile,
03:23has not developed significant side effects
03:27that have somehow blocked the use of this therapy.
03:31And what does this approval for Pierre Fabre Pharma represent?
03:35Engaged in the hematological area for more than 40 years,
03:38we asked Maria Elena Soffiantini,
03:41Market Access and Public Affairs Director of the French company.
03:45It is a great source of pride.
03:47The advantages brought by the first cellular allogeneic therapy
03:52are important because it is a life-saving therapy,
03:56in particular in a therapeutic area
04:00in which patients do not have many therapeutic options.
04:04We keep in mind that post-treatment proliferative lymph disease
04:10can make both pediatric patients and adult patients ill
04:14who have had or undergone a transplant,
04:18both heart, lung, kidney, but also kidney.
04:24This is why we are really satisfied
04:27to make available to Italian doctors
04:30this first allogeneic therapy
04:33for patients suffering from post-treatment proliferative lymph disease,
04:38positive to the Epstein-Barr virus,
04:40and who have not responded to first-line therapies.