Cell Therapeutics, the Seattle-based biopharma developer focused on targeted oncology therapeutics which cover a broad spectrum of blood-related cancers, was excited to report today that their revolutionary anti-lymphoma compound, PIXUVRI® (Pixantrone), has been cleared for access to Italian markets by the nation's primary regulatory body, the AIFA (Italian Medicines Agency), following the adoption last year in May by the EC (European Commission) of conditional marketing authorization status for the EU.
PIXUVRI's original market authorization in the EU, as a monotherapy for adults with aggressive B-cell NHL (non-Hodgkin lymphoma), where the patient has failed prior therapy lines, is extended here via the new AIFA classification for availability in Italian hospitals. Multiply relapsed or refractory NHL of this type was shown to be dealt with exceptionally well by PIXUVRI during the PIX301 randomized clinical Phase 3 trialing (published by The Lancet Oncology) which led up to the initial EU approval last year. The AIFA is already chomping at the bit to get relevant reimbursement and pricing data to patients, with a publication of such data alongside their conclusive determinations expected sometime here in the next eight weeks via the Official Gazette.
The superior performance of this compound compared to other chemotherapeutic agents, as demonstrated in the Phase 3 trials, hinges on the novel and unique structural, as well as physiochemical properties of PIXUVRI. Compared to the other anti-tumor agents in the trial, which are typically used in relapsed cases, PIXUVRI has a strong performance lead due to its ability to form extremely stable DNA adducts, in conjunction with its ingenious structural design. The structural design prevents binding with iron and thus halts oxygen radical production or the formation of a durable hydroxyl metabolite, massively delimiting the risk of anthracycline (the typical class of chemotherapy compounds) induced cardiotoxicity. This means that even patients who have been on chemo for a long time (near maximum lifetime exposure) can utilize PIXUVRI without a huge cardiotoxicity risk.
It is easy to see why the AIFA followed the EC decision here, based on clinical trial efficacy data alone, but when you factor in the grim reality that no approved agents or standards of care existed prior to PIXUVRI's approval, the market dynamics become obvious. With Pixantrone becoming available in Italian hospitals, this is great news for a staggering number of people with NHL in Italy, where there were some 12.7k new cases diagnosed last year alone (this does not count undiagnosed cases, of which there are many more). Half of cases are typically aggressive B-cell NHL and the current chemo lines simply do not work for a third of these patients, who typically end up exiting anthracycline-based combination therapy trapped in a progressive disease. Patients who fail or relapse after the second line treatment (again generally half of this group) have only palliative options to look forward to and that is why the marketing authorization for PIXUVRI is so important.
The full Summary of Product Characteristics on PIXUVRI, including safety and efficacy data, is available at www.Pixuvri.eu
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