Approvals

The FDA approved Rozlytrek for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer. Also, Rozlytrek secured accelerated approval for the treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

The FDA approved Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy.

TB Alliance became the first nonprofit organization to win regulatory approval from the U.S. Food and Drug Administration for a new drug aimed at treating some of the most drug-resistant forms of tuberculosis.

Merck’s Keytruda has become one of the best-selling drugs in the world. Last year, it generated more than $7 billion in revenue for Merck and that is only predicted to grow, particularly as the drug wins approval for new indications.

Today it was announced that the U.S. Food and Drug Administration approved Regeneron Pharmaceuticals’ prefilled syringes for Eylea.

Waylivra was rejected by the FDA last year but gained approval in Europe in May. The publication of final Phase III data in the New England Journal of Medicine could support a potential bid for regulatory approval in the U.S.

The approval is for only “select” patients where surgery isn’t an option. It also comes with a Boxed Warning for liver toxicity, which has been a problem in several clinical trials with the drug.

The U.S. Food and Drug Administration approved Bayer’s Nubeqa (darolutamide) for non-metastatic castration-resistant prostate cancer.

The U.S. Food and Drug Administration approved the anti-PD-1 therapy as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 with disease progression after one or more previous lines of systemic therapy.

It is the first and only nasally-dosed glucagon, which is indicated for diabetic patients undergoing a severe drop in blood sugar. Previously it was only administered by a complicated injection system.