Keytruda, Tecentriq Clinical Trial Warning Tops SPT Week in Review

5. FDA OKs First Label Update to Include Data on Psoriasis Involving the Genital Area

The FDA has approved an updated label for Eli Lilly’s ixekizumab (Taltz) injection 80 mg/mL to include data in psoriasis involving the genital area, making it the first and only FDA-approved treatment for moderate-to-severe plaque psoriasis that includes such data in its label. Read more here.

4. FDA OKs Prolia for Treatment of Glucocorticoid-Induced Osteoporosis

Officials with the FDA have approved the use of denosumab (Prolia, Amgen) for the treatment of glucocorticoid-induced osteoporosis. Read more here.

3. Dupilumab Benefits Patients with Uncontrolled Severe Asthma in Phase 3 Studies

Dupilumab (Dupixent) significantly reduced the risk of severe asthma attacks, improved lung function, and reduced dependence on oral corticosteroids (OCS) in 2 pivotal phase 3 studies. Read more here.

2. Hospital-Acquired Antibiotic-Resistant Infections on the Rise in Children

Hospital-acquired antibiotic-resistant Acinetobacter baumannii is on the rise among children across the United States, putting those with chronic conditions at higher risk of infection. Read more here.

1. FDA Warns of Decreased Survival in Some Patients Treated with Keytruda, Tecentriq Monotherapy

Officials with the FDA are warning about decreased survival associated with the use of cancer immunotherapies pembrolizumab (Keytruda) and atezolizumab (Tecentriq) in ongoing clinical trials. Read more here.