Pharmacy |

Health Canada approves new indication for daratumumab

Published on December 18, 2018December 18, 2018 by HT Staff

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]

CHMP recommends BV+AVD for Hodgkin lymphoma

Published on December 18, 2018December 18, 2018 by HT Staff

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]

Romiplostim now approved for children with ITP

Published on December 15, 2018December 15, 2018 by HT Staff

Vials of drugs
Photo by Bill Branson

The thrombopoietin receptor agonist romiplostim (NPlate®) is now approved by the U.S. Food and Drug Administration (FDA) to treat pediatric patients 1 year and older who have had immune thrombocytopenia (ITP) for at least 6 months and have not responded sufficiently to corticosteroids, immunoglobulins, or splenectomy. Romiplostim was... [Read Article]

Serious side effect of AML treatment going unnoticed, FDA warns

Published on November 30, 2018November 30, 2018 by HT Staff

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]

EC approves product for hemophilia A

Published on November 29, 2018November 29, 2018 by HT Staff

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]

EC approves mogamulizumab for MF, SS

Published on November 28, 2018November 28, 2018 by HT Staff

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]

Canada expands approval for antihemophilic factor

Published on November 28, 2018November 28, 2018 by HT Staff

Adynovate
Photo courtesy of Baxalta

Health Canada has extended the approved indication for Adynovate, a recombinant pegylated factor VIII (FVIII) product, in patients with hemophilia A. The product is now approved for use in hemophilia A patients under the age of 12 for the control and prevention of bleeding episodes, as prophylaxis to prevent... [Read Article]

Pegfilgrastim biosimilar approved by EC

Published on November 28, 2018November 28, 2018 by HT Staff

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]

EC approves pegfilgrastim biosimilar

Published on November 27, 2018November 27, 2018 by HT Staff

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]

Haplo-HSCT feasible in multiple myeloma

Published on November 23, 2018November 21, 2018 by Andrew D. Bowser

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]

FDA approves venetoclax for AML

Published on November 21, 2018November 21, 2018 by Jen Smith

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]

FDA approves glasdegib for AML

Published on November 21, 2018November 21, 2018 by Jen Smith

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]

FDA approves first treatment for primary HLH

Published on November 20, 2018 by Jen Smith

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]

Eltrombopag approved as first-line SAA therapy

Published on November 17, 2018November 17, 2018 by HT Staff

Eltrombopag (Promacta)
Photo courtesy of GSK

The U.S. Food and Drug Administration (FDA) has expanded the approved use of eltrombopag (Promacta®) in severe aplastic anemia (SAA). Eltrombopag is now approved for use in combination with standard immunosuppressive therapy as first-line treatment for adults and pediatric patients age 2 and older with SAA. Eltrombopag received... [Read Article]

Quick FDA approval for brentuximab vedotin in PTCL

Published on November 16, 2018November 16, 2018 by HT Staff

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]