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Weekly Drug News Round-Up: November 1, 2017

AstraZeneca’s Calquence Gains Quick FDA Approval for Lymphoma

Mantle cell lymphoma is a rare but fast-growing type of non-Hodgkin lymphoma, affecting 3% to 10% of cases Read More...

Beating an expected approval date that was set for the the first quarter of 2018, the U.S. Food and Drug Administration this week approved AstraZeneca’s Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Calquence is a kinase inhibitor, and in a single-arm trial that included 124 patients, 40% of patients had a complete response while 41% had a partial response. Common side effects include headache, diarrhea, bruising, fatigue, muscle pain (myalgia); and reduced levels of certain blood cells. Imbruvica (ibrutinib) is another kinase inhibitor used in mantle cell lymphoma.

FDA Clears Xarelto 10 mg for Extended VTE Prevention

Up to 20% of patients will have a recurrent venous thromboembolism (VTE) within 3 years if treatment is stopped Read More...

The FDA has approved Janssen's Xarelto (rivaroxaban) 10 mg once daily to lower the risk of recurrent venous thromboembolism (VTE) in patients who have completed at least six months of initial anticoagulation therapy. VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often the legs), and pulmonary embolism (PE), a clot that travels to the lung. In the Phase 3 EINSTEIN CHOICE study, both 10 mg and 20 mg once-daily doses were superior to aspirin in reducing the risk of recurrent VTE, by 74% and 66%, respectively. Low rates of major bleeding (0.3% to 0.5%) were seen in all 3 groups.

Varubi IV Soon Available for Delayed Chemotherapy-Induced Nausea, Vomiting

Delayed nausea and vomiting (CINV) can occur between 25 and 120 hours after chemotherapy Read More...

Tesaro’s Varubi (rolapitant) IV (intravenous) has been FDA-approved to be used with other antiemetics for the prevention of delayed nausea and vomiting associated with emetogenic (causing nausea and vomiting) cancer chemotherapy. Varubi is an NK1 receptor antagonist that blocks chemicals in the body that trigger nausea and vomiting. In clinical trials, Varubi, when given with a 5-HT3 receptor antagonist and dexamethasone, was superior to a 5-HT3 receptor antagonist and dexamethasone alone in preventing delayed chemotherapy induced nausea and vomiting in patients receiving either moderately or highly emetogenic chemotherapy. The IV form of Varubi, originally approved as a tablet, is expected to be available this month.

Length of Acetaminophen Use in Pregnancy and Offspring ADHD Risk: Study

The study found only an association, not a causal link, and pregnant women should always talk their doctor before using any medications Read More...

Research published in the journal Pediatrics adds more data about the association of acetaminophen (Tylenol) use in pregnancy and development of attention deficit hyperactivity disorder (ADHD) in offspring. Acetaminophen has long been recommended in pregnancy for headaches, fevers, and mild pain. Researchers found when expectant women used acetaminophen for 29 days or longer during pregnancy, offspring were twice as likely to be diagnosed with ADHD, compared to women who did not use the drug. However, when women used the drug for a week or less, their offspring showed a slightly decreased risk of ADHD. Experts note that untreated fevers carry a risk and expectant moms should not be scared to use acetaminophen.

Lack of Awareness May Spur Spread of Hepatitis C

Only about 55% of people infected with hepatitis C virus know they have it Read More...

Hepatitis C virus can cause liver disease, cirrhosis and liver cancer and resulted in about 23,000 deaths in the United States in 2016 -- a toll that's rising every year, according to experts. Risk factors for hep C include injection drug use, medical or dental procedures abroad, unsterile tattoos and piercings and blood transfusions received before 1992. Hep C can be spread via blood, it’s often symptomless and there is a lack of routine screening to diagnose it. In many states, Medicare restricts treatment to people with advanced disease, but drugs that can aid in a Hep C cure -- such Harvoni (ledipasvir and sofosbuvir) and Epclusa (sofosbuvir and velpatasvir) are available today. Here you can learn more about Hepatitis C.