Leukemias

Glasdegib NDA Granted Priority Review for Acute Myeloid Leukemia

By June 28, 2018

Glasdegib, an investigational oral smoothened (SMO) inhibitor, is a once-daily therapy that is thought to work by disrupting the Hedgehog pathway.

CAR-T Therapy Kymriah Approved for Relapsed/Refractory Large B-Cell Lymphoma

By May 02, 2018

Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence.

Duvelisib NDA Gets Priority Review for Relapsed/Refractory CLL/SLL, Follicular Lymphoma

By April 09, 2018

Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.

First-in-Class Treatment for Hairy Cell Leukemia Under FDA Priority Review

By April 03, 2018

Moxetumomab pasudotox is an investigational anti-CD22 recombinant immunotoxin.

Blincyto Gains Expanded Use for Leukemia With MRD Presence

By March 29, 2018

Blincyto has been granted accelerated approval for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease.

Tasigna Gains Expanded Indication for Rare Pediatric Leukemia

By March 22, 2018

The expanded approval was supported by 2 studies evaluating the safety and efficacy of Tasigna in 69 pediatric patients aged 2 to <18 years with Ph+ CML-CP who were either newly diagnosed (first-line) or who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy (second-line).

FDA: Certain CML Patients on Nilotinib May Be Eligible to Stop Treatment

By December 26, 2017

Patients with early (chronic) phase CML who have been taking Tasigna for three years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking Tasigna.

Bosulif Approved to Treat Adults With Newly-Diagnosed Chronic Phase Ph+ CML

By December 20, 2017

Expanded indication includes adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.

FDA Approves Besponsa for Relapsed, Refractory B-Cell ALL

By August 17, 2017

"These patients [with B-cell ALL who do not respond to initial treatment] have few treatments available and today's approval provides a new, targeted treatment option," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence.

Vyxeos Approved for Two Types of Acute Myeloid Leukemia

By August 03, 2017

The approval was supported by data from a study in 309 patients (60-75 years of age) with newly diagnosed t-AML or AML-MRC who were randomized to either Vyxeos or daunorubicin and cytarabine separately.

Idhifa Approved for Relapsed/Refractory AML with IDH2 Mutation

By August 01, 2017

The drug carries a Boxed Warning regarding the risk of differentiation syndrome.

Amneal Initiates Temporary Import of Cancer Drug Due to Shortage

By July 13, 2016

Amneal Biosciences announced that due to the current shortage of Bleomycin Sulfate for Injection, USP, 15 Units and 30 Units per vial, they have initiated a temporary importation of Bleomycin Sulfate Powder for Injection 15,000 IU per vial to the market.

Study Finds Triptorelin Doesn't Prevent Ovarian Failure

May 31, 2016

Triptorelin plus norethisterone (GnRHa) does not prevent chemotherapy-induced premature ovarian failure (POF) in young patients with lymphoma, according to a study published online in the Journal of Clinical Oncology.

Antibody Tx Finds Greater Benefits for Leukemia Patients, Study Finds

January 07, 2016

Results for patients with acute leukemia

ASH: Venetoclax, Acalabrutinib Active in Relapsed CLL

December 08, 2015

Oral venetoclax and acalabrutinib are active in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to two studies published online December 7 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American Society of Hematology, held from December 5 to 8 in Orlando, Florida.

FDA Approves First Generic Version of Gleevec

December 08, 2015

The first generic version of the cancer drug Gleevec (imatinib mesylate) has been approved by the U.S. Food and Drug Administration.

Exercise Important for Men After Cancer Diagnosis

January 28, 2014

Men who are physically active after a cancer diagnosis have significantly improved survival.