Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma.
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.
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).
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.
Expanded indication includes adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia.
"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.
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.
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.
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.
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.