Health Canada approves new indication for daratumumab

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Daratumumab (Darzalex)
Photo courtesy of Janssen
Health Canada has approved a third indication for daratumumab (Darzalex®) in multiple myeloma (MM). The drug is now approved for use in combination with bortezomib, melphalan, and prednisone (VMP) to treat patients with newly diagnosed MM who are ineligible for autologous stem cell transplant. Health Canada previously approved... [Read Article]
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CHMP recommends BV+AVD for Hodgkin lymphoma

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Brentuximab vedotin
Photo from Business Wire
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the marketing authorization for brentuximab vedotin (BV). The CHMP has recommended approval for BV (Adcetris) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) to treat adults with previously untreated, CD30+, stage IV Hodgkin... [Read Article]
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Serious side effect of AML treatment going unnoticed, FDA warns

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Enasidenib (Idhifa®)
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) has released a safety communication warning that cases of differentiation syndrome are going unnoticed in patients treated with the IDH2 inhibitor enasidenib (Idhifa). Enasidenib is FDA-approved to treat adults with relapsed or refractory acute myeloid leukemia (AML) and an IDH2... [Read Article]
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EC approves product for hemophilia A

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Damoctocog alfa pegol (Jivi)
Photo from Bayer
The European Commission (EC) has approved damoctocog alfa pegol (Jivi®), a recombinant human factor VIII therapy. Damoctocog alfa pegol (formerly BAY94-9027) is approved for the treatment and prophylaxis of bleeding in previously treated patients age 12 and older who have hemophilia A. The approval is valid in... [Read Article]
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EC approves mogamulizumab for MF, SS

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Micrograph showing
mycosis fungoides
The European Commission (EC) has granted marketing authorization for mogamulizumab (Poteligeo), a humanized monoclonal antibody directed against CCR4. This means mogamulizumab is approved for use in adults with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. This approval is valid in all... [Read Article]
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Pegfilgrastim biosimilar approved by EC

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Nurse bandaging
chemotherapy patient
Photo by Rhoda Baer
The European Commission (EC) has granted marketing authorization for Sandoz’s pegfilgrastim product Ziextenzo®, a biosimilar of Amgen’s Neulasta. Ziextenzo is approved for the same use as the reference medicine—to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults receiving cytotoxic chemotherapy for... [Read Article]
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EC approves pegfilgrastim biosimilar

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Cancer patient receiving chemotherapy
Photo by Rhoda Baer
The European Commission (EC) has approved Mundipharma’s pegfilgrastim product Pelmeg, a biosimilar of Amgen’s Neulasta. Pelmeg is approved for use in reducing the duration of neutropenia and the incidence of febrile neutropenia in adults who receive cytotoxic chemotherapy for malignancies, with the exceptions of chronic... [Read Article]
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Haplo-HSCT feasible in multiple myeloma

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Micrograph showing MM
A retrospective study suggests haploidentical hematopoietic stem cell transplant (haplo-HSCT) is feasible in patients with multiply relapsed or high-risk multiple myeloma (MM). Investigators said haplo-HSCT produced an “acceptable” rate of non-relapse mortality (NRM)—21% at 1 year—in such patients. “Our results demonstrate that [haplo-HSCT] can be safely performed in appropriate patients with... [Read Article]
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FDA approves venetoclax for AML

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Venetoclax
Photo courtesy of Abbvie
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to venetoclax (Venclexta®) for use in acute myeloid leukemia (AML). The BCL-2 inhibitor is now approved for use in combination with azacitidine, decitabine, or low-dose cytarabine to treat adults with newly diagnosed AML who are age 75 and... [Read Article]
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FDA approves glasdegib for AML

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AML cells
Image by Lance Liotta
The U.S. Food and Drug Administration (FDA) has approved the hedgehog pathway inhibitor glasdegib (Daurismo™) to treat certain patients with acute myeloid leukemia (AML). Glasdegib is approved for use in combination with low-dose cytarabine (LDAC) to treat adults with newly diagnosed AML who are age 75 and older... [Read Article]
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FDA approves first treatment for primary HLH

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Emapalumab (Gamifant)
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) has approved emapalumab-lzsg (Gamifant®) to treat primary hemophagocytic lymphohistiocytosis (HLH). Emapalumab, an interferon gamma-blocking antibody, is approved to treat to treat patients of all ages (newborn and older) with primary HLH who have refractory, recurrent, or progressive disease or who cannot... [Read Article]
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Quick FDA approval for brentuximab vedotin in PTCL

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Brentuximab vedotin
Photo from Business Wire
The U.S. Food and Drug Administration (FDA) has approved a new indication for brentuximab vedotin (ADCETRIS®) less than 2 weeks after receiving the completed supplemental biologics license application (sBLA). Brentuximab vedotin is now approved for use in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) to treat adults with... [Read Article]
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