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Weekly Drug News Round-Up: September 6, 2017

Mylotarg Returns to U.S. Market for Acute Myeloid Leukemia

Mylotarg initially received accelerated approval in May 2000 as treatment for relapsed CD33-positive acute myeloid leukemia Read More...

In June 2010 Pfizer's Mylotarg (gemtuzumab ozogamicin) used for acute myeloid leukemia (AML) was voluntarily withdrawn from the U.S. market due to effectiveness and safety questions, including patient deaths. Now the U.S. Food and Drug Administration (FDA), after a careful review, has granted Mylotarg approval for two new uses: for initial use in adults whose AML tumors express the CD33 antigen and for patients aged 2 years and older with relapsed or refractory (not responded to initial treatment) CD33-positive AML. The new approval includes a lower recommended dose, a different schedule in combination with chemotherapy or on its own, and a new patient population.

Teva’s Austedo Cleared for Tardive Dyskinesia in Adults

Austedo was first approved for the treatment of Huntington’s chorea in April 2017 Read More…

Tardive dyskinesia (TD) is a debilitating and often irreversible movement disorder involving uncontrollable movements of the tongue, lips, face, trunk and extremities caused by medications such as older antipsychotics or stomach medicines like metoclopramide. Tardive dyskinesia affects around 500,000 people in the United States. The FDA has now approved Austedo (deutetrabenazine) to treat TD based on two Phase III randomized, double-blind, placebo-controlled studies assessing the efficacy and safety of Austedo in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (AIM-TD and ARM-TD). Ingrezza (valbenazine) is also approved to treat TD.

Genentech’s Actemra Ok’d for Serious CAR T-Cell Therapy Side Effect

In studies, high-dose corticosteroids could be used alongside Actemra Read More...

Kymriah is a novel chimeric antigen receptor (CAR) T-cell gene therapy approved last week for advanced acute lymphoblastic leukemia. Alongside this approval, the FDA granted a new indication for Actemra (tocilizumab) to treat a serious, possibly life-threatening side effect due to CAR T-cell therapy: cytokine release syndrome (CRS) in patients two years of age and older. CRS occurs as an expected immune response to the CAR T-cell therapy. Approval is based on two studies that confirmed resolution of CRS within 14 days of the first dose of Actemra. Thirty-one out of 45 patients achieved a response, defined as resolution of CRS within 14 days of the first dose of Actemra. To learn more about CRS, read: CAR T-Cell Therapy: A Healthcare Professional's Guide - Adverse Events.

Faslodex Cleared for Initial Use in HR+, HER2- Advanced Breast Cancer

First approved in 2002, Faslodex has been used as a monotherapy following prior antiestrogen therapy Read More...

Faslodex (fulvestrant) is a hormonal therapy that blocks the estrogen receptor (ER) to slow breast cancer growth and target it for degradation. The FDA has cleared AstraZeneca’s Faslodex as initial monotherapy (single treatment) in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. In the FALCON trial of 462 postmenopausal women with HR+ metastatic or locally-advanced breast cancer, a significant median progression-free survival (PFS) of 16.6 months was demonstrated in patients who received Faslodex, compared to 13.8 months in patients receiving the aromatase inhibitor Arimidex (anastrozole).

FDA MedWatch: Separate Kayexalate Dosing From Other Drugs

Patients should not stop their potassium-lowering medicines without talking to their doctor first Read More...

Kayexalate (sodium polystyrene sulfonate) is used to treat hyperkalemia, a serious condition of high blood potassium that may seriously affect heart rhythm. It works by binding with potassium in the intestines before elimination. However, the FDA is now warning that Kayexalate can bind to, prevent absorption, and reduce effectiveness of other drugs when taken by mouth at the same time. Kayexalate administration should be separated from other orally administered prescription or over-the-counter medicines by at least 3 hours (3 hours before or 3 hours after). Increase to 6 hours for patients with gastroparesis or delayed emptying of food from the stomach. Review other Kayexalate drug interactions here.