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Weekly Drug News Round-Up: October 26, 2016

Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile

Symptoms of Clostridium difficile infection include mild-to-severe diarrhea, abdominal pain and fever Read More...

Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for CDI and who are at high risk for CDI recurrence. Zinplava is not an antibacterial and does not treat an active CDI infection. Zinplava is a human monoclonal antibody that binds with C. difficile toxin B to prevent its effects on human cells. Common adverse reactions include nausea, pyrexia and headache. Heart failure, a serious adverse reaction, was noted in 2.3% of Zinplava-treated patients and 1.0% of placebo-treated patients.

Lilly’s Lartruvo Gains Accelerated Approval for Soft Tissue Sarcoma

Lartruvo is the first new initial treatment for soft tissue sarcoma since doxorubicin over 40 years ago Read More...

The FDA has granted accelerated approval to Lartruvo (olaratumab) to be used with the chemotherapy drug doxorubicin for treatment of patients with soft tissue sarcoma (STS) who cannot be cured with radiation or surgery. Lartruvo acts as a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody to help slow or stop tumor growth. In clinical trials, patients who received Lartruvo with doxorubicin had a statistically significant improvement in overall survival: the median survival was 26.5 months compared to 14.7 months for patients who received doxorubicin alone. Common side effects included nausea, fatigue, low white blood cells (neutropenia), and muscle pain, among others.

Keytruda Now First-Line for Advanced Non-Small Cell Lung Cancer

The trial was stopped early in June 2016 to allow patients still on chemotherapy the opportunity to receive Keytruda Read More...

Merck’s anti-PD-1 (programmed death receptor-1) therapy Keytruda (pembrolizumab) has been approved for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK genomic tumor aberrations. Based on interim data from KEYNOTE-024, Keytruda reduced the risk of progression or death by 50 percent compared to chemotherapy (HR, 0.50 [95% CI, 0.37, 0.68]; p<0.001). Keytruda is now the only anti-PD-1 therapy approved as first-line treatment for this patient population. Immune-mediated side effects include inflammation of the lungs, colon, liver, kidney and endocrine gland problems.

FDA Alert: Testosterone and Other Anabolic Androgenic Steroids

Prescription testosterone is approved as hormone replacement therapy for men with certain medical conditions Read More...

FDA has updated labeling for all prescription testosterone products regarding new safety information related to abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). Abuse of testosterone and related products, usually at high doses, may occur in adolescent and adult body builders and athletes. Serious side effects such as heart attack, heart failure, stroke, depression, hostility, aggression, liver toxicity, and male infertility have been reported. Individuals abusing high doses of testosterone have also reported withdrawal symptoms. In addition, labeling will advise prescribers of the importance of measuring serum testosterone concentration if abuse is suspected.

CDC Recommends New HPV Vaccine Schedule

The vaccine protects against infection with sexually transmitted HPV, which can cause cervical and other cancers Read More...

The Centers for Disease Control and Prevention (CDC) released recommendations this past week that 11- to 14-year-olds only need two doses of human papillomavirus (HPV) vaccine given at least 6 months apart, instead of the previously required 3 shots. Adolescents and young adults who start receiving the vaccine at ages 15 to 26 still need three doses. Clinical trials showed two HPV vaccine doses at age 9 to 14 triggered an immune response similar to or higher than 16 to 26 year olds who received three doses. On October 7th the FDA approved adding a two-dose schedule for Gardasil 9 HPV vaccine for children ages 9 to 14.