Skip to Content

Weekly Drug News Round-Up: August 2, 2017

FDA Approves Celgene’s Idhifa for IDH2 Mutated Acute Myeloid Leukemia

Labeling includes a boxed warning for possibly fatal differentiation syndrome Read More...

The U.S. Food and Drug Administration (FDA) has approved Celgene's Idhifa (enasidenib), a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation. In a single arm trial of 199 patients after at least 6 months of treatment, 19% of patients experienced complete remission for a median 8.2 months, and 4% of patients experienced complete remission with partial hematologic recovery for a median 9.6 months. Common side effects include nausea, vomiting, diarrhea, increased levels of bilirubin (substance found in bile) and decreased appetite.

Opdivo Cleared for Progressive MSI-H or dMMR Metastatic Colorectal Cancer

In the CheckMate-142 study, 74 patients received Opdivo every 2 weeks until disease progression or unacceptable toxicity Read More…

According to researchers, patients with metastatic colorectal cancer who have mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors are less likely to respond to conventional chemotherapy. In response, the FDA has approved Opdivo (nivolumab), a programmed death receptor-1 (PD-1) blocking antibody, for adult and pediatric (12 years and older) patients with MSI-H or dMMR metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. In studies of patients who progressed following these treatments, Opdivo demonstrated an overall response rate (ORR) of 28%, including a 1.9% complete response rate (1/53) and a 26% partial response rate (14/53).

Imbruvica Approved for GVHD After Stem Cell Transplant

This is the first FDA-approved therapy for the treatment of cGVHD Read More...

The FDA has approved Imbruvica (ibrutinib), a kinase inhibitor, for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of systemic therapy. GVHD, which causes damage to skin, mouth, and liver, can occur after a bone marrow or stem cell transplant where transplanted cells attack the recipient. In studies, 42 patients with cGVHD after failure of first-line corticosteroid therapy received ibrutinib orally at 420 mg once daily. Overall response rate was 67%, or 28 patients. The median time-to-response was 12.3 weeks (range, 4.1 to 42.1 weeks) and responses lasting five months or longer were observed in 48% of the patients.

Study: Should Stroke Survivors Stay on Statins for Life?

Ischemic stroke, the most common type of stroke, is caused by blocked blood flow to the brain Read More…

Stroke survivors who stop taking cholesterol-lowering statins are at increased risk for another stroke, as published today in the Journal of the American Heart Association (JAMA). Statins include drugs such as Crestor (rosuvastatin) and Lipitor (atorvastatin), commonly prescribed for high cholesterol. Researchers studied more than 45,000 ischemic stroke survivors who were prescribed a statin within 90 days of leaving the hospital. Compared to those who continued taking statins, patients who stopped their statin 3 to 6 months after their stroke were 42% more likely to suffer another stroke within a year, and 37% more likely to die from any cause.

Recent Flu Shot Should Not Halt Second Vaccine in Pregnancy

Influenza can be severe in pregnancy, leading to preterm delivery, stillbirths, and even death of the mother Read More...

Guidelines recommend a flu shot during pregnancy to help protect mother and baby from influenza. However, it wasn't known whether a second vaccine would work if a woman had already received a flu shot recently. A new study published in the journal Vaccine shows this is not the case. Researchers tested blood from 141 pregnant women before and after flu vaccinations. Fifty women had not been vaccinated the previous year, while 91 were. Overall, protection levels among all women -- vaccinated earlier or not -- were not different at the time of delivery. Women vaccinated the second time had less flu protection only in the month after the second vaccine. In addition, the flu protection levels in the newborns were good.