Home » Leukemia, Aifa approves a new oral drug

Leukemia, Aifa approves a new oral drug

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Leukemia, Aifa approves a new oral drug

Chronic lymphocytic leukemia (CLL) is one of the most common forms of leukemia in adults: one in three leukemia diagnoses is CLL, and is generally made at an average age of 70 years, slightly more in men: in Italy they estimate approximately 1600 cases per year in men and 1150 in women. Sometimes it shows no signs, and is discovered by chance, because routine tests are done or to look for something else, and an excessive growth of white blood cells is noticed, a growth that raises suspicion of the disease. But when the disease shows signs and becomes aggressive, we need to intervene immediately. CLL is part of the large family of non-Hodgkin lymphomas, which together rank fifth among the most common neoplasms. A very rare lymphoma, such as that of the marginal zone, also belongs to this family. It can arise at any time in life but statistically the diagnosis occurs after the age of 60, the disease has a slow progression and in Europe the estimate is 20-30 diagnoses per year per million inhabitants.

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A new opportunity

What do these two diseases have in common? The answer was given by Aifa, which authorized treatment with zanubrutinib – a new generation drug already approved for another lymphoma, Waldenstrom’s macroglobulinemia – both for chronic lymphocytic leukemia and for patients with marginal zone lymphoma after at least one previous therapy with antiCD20 antibodies, providing for reimbursement in class H (hospital prescription with therapeutic plan). And the company that produces this drug, BeiGene, founded just 13 years ago in the United States from an intuition of one of the youngest members of the American Academy of Sciences, Xiaodong Wang, predicts that other authorizations may arrive for other oncohematological diseases, while their studies are also starting to focus on some solid tumors.

When you no longer respond

The approval of a new drug is always important news, especially where doctors need to have different tools to use when people do not respond well to certain drugs, or no longer respond, which often happens when we talk about chronic diseases. This is why the arrival of a new drug – in this case a Bruton’s tyrosine kinase inhibitor – is always viewed with great optimism. The teacher is no exception Francesca Romana Mauro, associate at the Sapienza Institute of Hematology in Rome. “The approval of zanubrutinb by Aifa is excellent news for us and for the patients we follow – he specifies – both because the biological drug has high therapeutic efficacy and because it has a good safety profile, especially at the cardiovascular. And, above all, because it is taken orally and it is easier for patients to follow the therapy. Especially when the disease is chronic and therefore the therapy is not suspended.”

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And it underlines the importance of having an oral medication available too Pier Luigi Zinzani, professor of Hematology at the University of Bologna who explains how we can think of a change in clinical practice for patients, having demonstrated this drug to be effective and safe for all three subtypes of marginal zone lymphoma, leading to a remission of the disease. Can therapy be suspended in the future without the disease returning? “Too early to say it and to try – replies Zinzani – in the meantime we are happy to reap important fruits for our patients”.

When drugs reach patients

Yes, because behind every trial and every approval there are them, the patients, and their families. Families often overwhelmed in their daily lives by an oncological diagnosis. “We are always here – he confirms Giuseppe Toro, president of Ail, the Italian association against leukemia, lymphoma and myeloma – with our information telephone lines, through our initiatives, with our support for research. The arrival of a new drug is always excellent news, but what really matters to patients is when it will be truly available, in every region of the country.” And often, instead, many months pass, up to 18, before patients from all the regions have the same care.

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