Wednesday, November 7, 2018

chronic lymphatic leukaemia | green light for ibrutinib, targeted treatment for 2 forms of blood cancer






green light for ibrutinib, targeted treatment for 2 forms of blood cancer


 
The European marketing Authorisation of ibrutinib (Imbruvica ®), an orally targeted therapy, represents a new hope for patients with 2 types of rare but aggressive blood cancers, chronic lymphoid leukemia (LLC) and Mantle cell lymphoma (LCM).

Mantle cell lymphoma is a rare disease that occurs more particularly in men aged 65 years on average.
In France, malignant hemic or blood cancers represent the 6th cause of cancer, with 35 000 cases per year. These blood cancers bring together many diseases that have certain commonalities. Among these diseases, chronic lymphoid leukemia (LLC, 4 500 new cases per year) and mantle cell lymphoma (LCM, 700 new cases per year) are infrequent but aggressive forms of malignant hemic.

LLC, an increasing frequency of relapses and resistance to treatment
Although chronic lymphocytic leukemia is a disease that generally evolves slowly, with an average survival of 18 months to more than 10 years depending on the stage of the disease, relapses and resistance to treatment are increasingly frequent over time. The forms with a 17p deletion (Del 17p) and a TP53 mutation are aggressive forms because these anomalies lead to the loss of a very important gene, TP53, which detects the presence of tumor cells and triggers the death of these cells. This same gene helps with tumor suppression during chemotherapy. However, over time, the 17p del and the TP53 mutation are becoming increasingly common, resulting in relapse or resistance to chemotherapy treatment, with the disease getting more and more aggressive.

LCM, a RARE ill-prognosis disease
Mantle cell lymphoma is a rare disease that occurs more particularly in men aged 65 years on average. This lymphoma is a complex disease that tends to propagate to other tissues and organs. This is a bad prognosis disease whose overall average survival is 1 to 2 years after the first relapse.

A new class targeted therapy
Ibrutinib (Imbruvica ®), developed by Janssen-Cilag International and Pharmacyclics is the first Burton tyrosine kinase inhibitor (BTK), and is the first targeted therapy against LLC and the LCM administered as an oral monotherapy in a Taken a day. This drug acts by binding to the BTK enzyme, which results in the blocking of the transmission of survival signals in malignant B cells. By blocking this BTK protein, Imbruvica ® helps to suppress and reduce the number of cancerous cells and to slow down the development of cancer.

The indications granted by the European authorities are:


-Treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one previous treatment, or in the first line in the case of 17p deletion or TP53 mutation in patients for whom immuno-chemotherapy is Inadequate.

-Treatment of adult patients with relapsed or refractory mantle cell lymphoma (LCM).

New Hope for patients
Imbruvica ® represents a new hope for patients fulfilling the conditions of its indication because efficacy data show for the LLC, a significant improvement in the survival without progression of the disease after 9.4 months of treatment ( 78% reduction in the risk of disease progression or death. These results were significantly higher compared with patients treated with ofatumumab (Arzerra ®).

For the LCM, a response rate of 68% was observed in refractory patients (21% full response and 47% partial response), with a median survival time of no progression of 13.9 months. This study did not compare with another treatment.

Finally, with respect to tolerance, the most common side effects (more than 20%) were diarrhea, musculoskeletal pain, upper respiratory tract infection, redness, nausea and fever, and a decrease in the rate Neutrophils (subtype of white blood cells) and constipation. anemia, pneumonia and a decrease in platelet levels were observed less frequently.

In France, ibrutinib has been available since April 2014 as part of a temporary permission to use (ATU) cohort in the LCM and LLC. More than 300 patients are treated in the indication of the European AMM.

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