Pharmacy |

PU-H71 receives orphan drug designation for myelofibrosis

Published on June 15, 2018June 13, 2018 by HT Staff

Micrograph showing myelofibrosis

The US Food and Drug Administration (FDA) has granted orphan drug designation to PU-H71 to treat patients with myelofibrosis. The drug specifically targets the epichaperome, a network of high-molecular- weight complexes found in multiple diseases, including cancer and neurologic disorders. These complexes enhance cellular survival, irrespective of tissue of origin or... [Read Article]

FDA grants pembrolizumab accelerated approval for PMBCL

Published on June 14, 2018June 13, 2018 by HT Staff

Pembrolizumab (Keytruda)
Photo courtesy of Merck

The US Food and Drug Administration (FDA) granted accelerated approval to the anti-PD-1 therapy pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL). The indication also includes patients who have relapsed after 2 or more prior lines of... [Read Article]

Mircera approved for anemia in pediatric patients with CKD

Published on June 13, 2018June 13, 2018 by HT Staff

Red blood cells

Mircera®, methoxy polyethylene glycol-epoetin beta, was approved by the US Food and Drug Administration (FDA) to treat anemia in pediatric patients who have chronic kidney disease (CKD). The drug is indicated for patients ages 5 to 17 years on hemodialysis who are switching from another erythropoiesis-stimulating agent (ESA) after their hemoglobin levels... [Read Article]

FDA approves venetoclax for CLL/SLL with or without del 17p

Published on June 10, 2018June 13, 2018 by HT Staff

First month’s supply of
venetoclax
Photo courtesy of Abbvie

The US Food and Drug Administration (FDA) has approved venetoclax tablets (Venclexta ®) in combination with rituximab to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received 1 prior therapy. The combination is approved for patients with or without... [Read Article]

Emicizumab granted priority review for hemophilia A without inhibitors

Published on June 7, 2018June 13, 2018 by HT Staff

Bleeding human finger
By Crystal (Crystl) from Bloomington, USA - Flickr

The US Food and Drug Administration (FDA) has granted priority review for emicizumab (Hemlibra®) for adults and children with hemophilia A without factor VIII inhibitors. Earlier this year, the agency awarded emicizumab breakthrough therapy designation for the same population. Emicizumab is a bispecific factor... [Read Article]

FDA approves first biosimilar pegfilgrastim

Published on June 5, 2018June 4, 2018 by HT Staff

Vials and a syringe

The US Food and Drug Association (FDA) has approved pegfilgrastim-jmdb (Fulphila™) as the first biosimilar to Neulasta®. The agents reduce the risk of infection or the duration of febrile neutropenia in patients treated with immunosuppressive chemotherapy for non-myeloid hematologic malignancies. The FDA approved Fulphila based on evidence that included extensive... [Read Article]

Over 1100 new meds, vaccines being developed to treat cancer

Published on June 4, 2018June 1, 2018 by HT Staff

Vials of drugs
Photo by Bill Branson

Currently, 1,120 new medicines and vaccines are being developed to treat cancer, according to a new report of the Pharmaceutical Research and Manufacturers of America (PhRMA). And all of them, the organization states, are in clinical trials or awaiting review by the US Food and Drug Administration (FDA).... [Read Article]

Eltrombopag receives priority review designation for SAA

Published on June 3, 2018June 3, 2018 by HT Staff

Eltrombopag (Promacta)
Photo courtesy of GSK

Eltrombopag (Promacta®) in combination with standard immunosuppressive therapy (IST) has received priority review designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA). The drug is already approved for SAA in the refractory setting for patients who have had an insufficient... [Read Article]

FDA grants priority review to gilteritinib for R/R AML

Published on May 30, 2018May 29, 2018 by HT Staff

AML cells

The US Food and Drug Administration (FDA) has granted priority review to gilteritinib for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have a FLT3 mutation. At present, no FLT3-targeting agents are approved for the treatment of R/R FLT3-mutation-positive AML, according to Astellas, the developer... [Read Article]