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FDA approves new treatment for adults with relapsed or refractory ALL

18 Août 2017

The U.S. Food and Drug Administration (FDA) has approved Besponsa (inotuzumab ozogamicin) for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

"These patients have few treatments available and today's approval provides a new, targeted treatment option", Dr Richard Pazdur, the FDA's director for cancer drugs, said in a statement.

The newly approved drug Besponsa binds to the B-cell ALL cancer cells which have a specia marker called the CD22 antigen.

In 2013, Pfizer stopped a phase III trial with the drug that later would be branded Besponsa in relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma, saying it would discontinue the drug in that indication after an independent data monitoring committee concluded during a scheduled interim analysis that the treatment would not meet the primary endpoint of improving OS compared with investigator's choice of bendamustine plus rituximab (Rituxan, Roche AG / Biogen Inc.) or gemcitabine plus rituximab. Among patients achieving CR/CRi, those treated with Besponsa also demonstrated a higher rate of minimal residual disease (MRD) negativity (78% [95% CI: 68%-87%]) compared to those treated with chemotherapy (28% [95% CI: 14%-47%]).

The potent injected drug, chemically as inotuzumab ozogamicin, carries the FDA's most-stringent warning because it can cause severe liver disease, including blocking veins in the liver.

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Pfizer Oncology global president Liz Barrett said: "The approval of Besponsa is an important step forward for adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, a rare disease that can be fatal within a matter of months if left untreated". The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR).

The complete remission rate (CR/CRi)* for patients treated with Besponsa was 81 percent [95% CI: 72%-88%] compared to 29 percent with chemotherapy [95% CI: 21%-39%]. The boxed warning also lists an increased risk of death for patients who take inotuzumab ozogamicin after receiving a certain type of stem cell transplant. Women who are pregnant or breastfeeding are not to be prescribed Besponsa because it may harm the developing fetus or the newborn breastfeeding baby.

B-cell precursor ALL is a fast progressing cancer of the bone marrow in which the bone marrow cells are cancerous and make too many B-cells lymphocytes. The FDA granted the approval of making and marketing Besponsa to Pfizer Inc. the drug is already approved in the European Union earlier this year.

Forty-eight percent of patients treated with Besponsa proceeded to hematopoietic stem cell transplantation (HSCT) compared to 22 percent treated with chemotherapy.

FDA approves new treatment for adults with relapsed or refractory ALL