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Weekly Drug News Round-Up: May 31, 2017

FDA Clears Keytruda For Any Solid Tumor Based on Biomarker

MSI-H and dMMR tumors affect the proper repair of DNA inside the cell Read More...

For the first time in cancer treatment, a drug has been FDA-approved based on a tumor’s biomarker (specific genetic marker) without regard to the tumor’s original location, such as with breast cancer. Merck’s Keytruda (pembrolizumab) can now be used for the treatment of patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). This use includes patients who have failed therapy with no alternatives and those with advanced colorectal cancer who failed certain chemotherapy drugs. In studies, a total of 15 cancer types were identified, most commonly colorectal, endometrial and other gastrointestinal cancers.

Lilly’s Taltz Under Study for Psoriatic Arthritis

Psoriatic arthritis can be disabling with stiffness, pain and swelling of the joints Read More...

Psoriatic arthritis affects about one in every 200 people and is often accompanied by the autoimmune skin disorder psoriasis. Taltz (ixekizumab), a monoclonal antibody that selectively targets interleukin-17A, is already approved to fight plaque psoriasis, but is now being researched to treat psoriatic arthritis. In a 6-month study published in The Lancet, patients received Taltz injections every 2 weeks, placebo injections every 2 weeks, or alternating injections of Taltz and the placebo every 2 weeks. Over 50% of patients treated with Taltz had a 20% reduction in tender, swollen joints (the primary endpoint) compared to only about 20 percent of those receiving the placebo.

Two Doses of HPV Shot Enough to Prevent Genital Warts: Study

HPV is a sexually transmitted virus that can also lead to cervical, vaginal and anal cancers Read More...

New research supports the recent CDC and WHO recommendation for two, rather than three, doses of the human papillomavirus (HPV) vaccine, for example Gardasil (HPV quadrivalent vaccine), to protect against genital warts in preteens and teens. Researchers from Boston University Medical Center looked at the prevalence of warts, vaccination rates, and number of doses among nearly 400,000 girls. In addition to the finding that 2 doses were as protective as 3, investigators also found that 2 doses offered more protection against genital warts than a single dose or no vaccine at all. However, other HPV-related concerns such as cervical dysplasia or cancer were not evaluated.

One Hundred Year Old Drug May Offer Hope to Autism Patients: Study

Suramin can block the ATP molecule and may halt the constant cell communication that may lead to ASD Read More...

Early research from the University of California, San Diego's School of Medicine has shown, in a very small study, that a 100-year old drug previously used to treat sleeping sickness may have a positive effect in autism spectrum disorder (ASD). In 10 boys aged 5 to 14 with autism, 5 received a single dose of suramin and 5 received placebo. In those receiving the active drug, a single dose of suramin produced improvements in language, social interaction and restricted and/or repetitive behaviors. The gain proved to be temporary and further research with larger studies will be needed.

Gene-Based Therapy for High Cholesterol Under Study

These agents may provide another option for patients who do not respond to statins Read More...

A new study published this past week in the New England Journal of Medicine shows that two new agents can successfully lower cholesterol by using a gene-based approach. Both agents work by blocking a specific gene -- the angiopoietin-like 3 (ANGPTL3) gene -- that inhibits cholesterol breakdown. Evinacumab is an antibody-based therapy that lowered triglycerides levels by up to 76 percent and LDL, or “bad” cholesterol by 23 percent. Another treatment from Ionis Pharmaceuticals also caused across-the-board reductions in cholesterol, triglycerides and LDL. This new method of cholesterol lowering differs from statins, which work by inhibiting the liver's ability to produce cholesterol. Research with the new mechanism is entering Phase 3 studies.