Lunes, 23 Julio, 2018

Drug for Rare Blood Cancer OK'd

Drug for Rare Blood Cancer OK'd Drug for Rare Blood Cancer OK'd
Danilo Martir | 18 Agosto, 2017, 19:01

Pfizer Inc. has secured Food and Drug Administration approval for Besponsa as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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.

As per the National Cancer Institute, an estimated 5,970 Americans will be diagnosed with the cancer and 1,440 will die from it, according to the National Cancer Institute.

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A higher post-HSCT non-relapse mortality rate occurred in patients treated with Besponsa (39%) than chemotherapy (23%). Nearly 6,000 people in the United States are likely to be diagnosed with the disease this year, and more than 1,400 are projected to die from it, according to estimates from the U.S. National Cancer Institute.

B-cell precursor ALL is an aggressive cancer in which an excess of B-cell lymphocytes are produced.

Inotuzumab ozogamicin is an antibody-drug conjugate comprised of a monoclonal antibody that targets CD22 - a cell surface antigen that is expressed on nearly all B-cell ALL cancer cells - linked to the cytotoxic agent calicheamicin. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR).

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In testing that included 218 patients, 36 percent given Besponsa had their cancer vanish for eight months on average; 17 percent of those given chemotherapy had remission for a median five months. "These patients have few treatments available and today's approval provides a new, targeted treatment option".

"Based on the results seen in the INO-VATE ALL trial, Besponsa improved multiple efficacy measures, including rates of hematologic remission, MRD negativity, and stem cell transplantation", said lead study investigator Hagop M. Kantarjian, MD, of the University of Texas MD Anderson Cancer Center, in a press release. 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%]).

Despite being an approved monotherapy for treating a rare type of leukemia among adults, patients are also warned of its side effects that include infection, anemia, hemorrhage, thrombocytopenia, neutropenia, leukopenia, pyrexia, febrile neutropenia, increased transaminases, increased gamma-glutamyltransferase, hyperbilirubinemia, fatigue, nausea, headache and abdominal pain.

Several people stabbed in Finnish city of Turku
Finnish police said they have reinforced security at Helsinki Airport and train stations throughout the country. Witnesses report seeing at least one person lying motionless on the ground in the city center's market square.

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