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Obinutuzumab, a monoclonal antibody, has been approved for treating patients with previously untreated chronic lymphocytic leukemia, the Food and Drug Administration announced Nov. 1.
The approval, which is for use in combination with chlorambucil, makes this the first drug to be approved with a "breakthrough therapy designation," according to an FDA statement.
Obinutuzumab is a CD20-directed antibody that is administered in an intravenous infusion, for 6 cycles. It is designed to attach to CD20, a protein found only on B cells, and "attacks targeted cells both directly and together with the body’s immune system," according to a statement issued by Genentech, the drug’s manufacturer. Genentech will market obinutuzumab as Gazyva.
The company requested breakthrough designation for obinutuzumab. The FDA can designate a drug as a breakthrough therapy at the manufacturer’s request "if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases," the FDA statement said.
Approval was based on a randomized, open-label study of 356 patients with previously untreated chronic lymphocytic leukemia (CLL), comparing obinutuzumab plus chlorambucil to chlorambucil alone. The median progression-free survival was 23 months in the obinutuzumab-treated group, compared with 11.1 months among those treated with chlorambucil alone, an 84% reduction in risk (hazard ratio, 0.16). The overall response rate also was higher among those on obinutuzumab (almost 76% vs. 32.1%), as were the complete response rate (27.8% vs. 0.9%) and the median duration of response (15.2 months vs. 3.5 months).
Infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and pyrexia were the most common adverse events reported among the patients treated with obinutuzumab. The prescribing information includes a boxed warning about the risk of hepatitis B reactivation, which in some cases, resulted in fulminant hepatitis, hepatic failure, and death; and progressive multifocal leukoencephalopathy (PML; reported in patients in other studies of obinutuzumab). A diagnosis of PML should be considered "in any patient presenting with new onset or changes to preexisting neurologic manifestations," the prescribing information states.
The Genentech statement notes that obinutuzumab will be available in the United States in about two weeks from approval. The drug is under review in other countries and in the European Union.
Citing National Cancer Institute estimates, the FDA statement said that 15,680 people in the United States will be diagnosed with CLL this year and 1,580 people will die from the disease.
The obinutuzumab label is available at the FDA website.
Obinutuzumab, a monoclonal antibody, has been approved for treating patients with previously untreated chronic lymphocytic leukemia, the Food and Drug Administration announced Nov. 1.
The approval, which is for use in combination with chlorambucil, makes this the first drug to be approved with a "breakthrough therapy designation," according to an FDA statement.
Obinutuzumab is a CD20-directed antibody that is administered in an intravenous infusion, for 6 cycles. It is designed to attach to CD20, a protein found only on B cells, and "attacks targeted cells both directly and together with the body’s immune system," according to a statement issued by Genentech, the drug’s manufacturer. Genentech will market obinutuzumab as Gazyva.
The company requested breakthrough designation for obinutuzumab. The FDA can designate a drug as a breakthrough therapy at the manufacturer’s request "if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases," the FDA statement said.
Approval was based on a randomized, open-label study of 356 patients with previously untreated chronic lymphocytic leukemia (CLL), comparing obinutuzumab plus chlorambucil to chlorambucil alone. The median progression-free survival was 23 months in the obinutuzumab-treated group, compared with 11.1 months among those treated with chlorambucil alone, an 84% reduction in risk (hazard ratio, 0.16). The overall response rate also was higher among those on obinutuzumab (almost 76% vs. 32.1%), as were the complete response rate (27.8% vs. 0.9%) and the median duration of response (15.2 months vs. 3.5 months).
Infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and pyrexia were the most common adverse events reported among the patients treated with obinutuzumab. The prescribing information includes a boxed warning about the risk of hepatitis B reactivation, which in some cases, resulted in fulminant hepatitis, hepatic failure, and death; and progressive multifocal leukoencephalopathy (PML; reported in patients in other studies of obinutuzumab). A diagnosis of PML should be considered "in any patient presenting with new onset or changes to preexisting neurologic manifestations," the prescribing information states.
The Genentech statement notes that obinutuzumab will be available in the United States in about two weeks from approval. The drug is under review in other countries and in the European Union.
Citing National Cancer Institute estimates, the FDA statement said that 15,680 people in the United States will be diagnosed with CLL this year and 1,580 people will die from the disease.
The obinutuzumab label is available at the FDA website.
Obinutuzumab, a monoclonal antibody, has been approved for treating patients with previously untreated chronic lymphocytic leukemia, the Food and Drug Administration announced Nov. 1.
The approval, which is for use in combination with chlorambucil, makes this the first drug to be approved with a "breakthrough therapy designation," according to an FDA statement.
Obinutuzumab is a CD20-directed antibody that is administered in an intravenous infusion, for 6 cycles. It is designed to attach to CD20, a protein found only on B cells, and "attacks targeted cells both directly and together with the body’s immune system," according to a statement issued by Genentech, the drug’s manufacturer. Genentech will market obinutuzumab as Gazyva.
The company requested breakthrough designation for obinutuzumab. The FDA can designate a drug as a breakthrough therapy at the manufacturer’s request "if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases," the FDA statement said.
Approval was based on a randomized, open-label study of 356 patients with previously untreated chronic lymphocytic leukemia (CLL), comparing obinutuzumab plus chlorambucil to chlorambucil alone. The median progression-free survival was 23 months in the obinutuzumab-treated group, compared with 11.1 months among those treated with chlorambucil alone, an 84% reduction in risk (hazard ratio, 0.16). The overall response rate also was higher among those on obinutuzumab (almost 76% vs. 32.1%), as were the complete response rate (27.8% vs. 0.9%) and the median duration of response (15.2 months vs. 3.5 months).
Infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and pyrexia were the most common adverse events reported among the patients treated with obinutuzumab. The prescribing information includes a boxed warning about the risk of hepatitis B reactivation, which in some cases, resulted in fulminant hepatitis, hepatic failure, and death; and progressive multifocal leukoencephalopathy (PML; reported in patients in other studies of obinutuzumab). A diagnosis of PML should be considered "in any patient presenting with new onset or changes to preexisting neurologic manifestations," the prescribing information states.
The Genentech statement notes that obinutuzumab will be available in the United States in about two weeks from approval. The drug is under review in other countries and in the European Union.
Citing National Cancer Institute estimates, the FDA statement said that 15,680 people in the United States will be diagnosed with CLL this year and 1,580 people will die from the disease.
The obinutuzumab label is available at the FDA website.
