Product Approvals and Launches

A new oral therapy approved by the FDA will provide patients with myelodysplastic syndromes, who typically visit a health care facility for intravenous treatment, with an oral at-home option that can be beneficial during the coronavirus pandemic.

The FDA today granted accelerated approval to the second biomarker-based indication for Merck’s pembrolizumab (Keytruda), an anti-PD-1 therapy, regardless of tumor type. A companion diagnostic to pembrolizumab, FoundationOne CDx was also today approved by the FDA as only approved companion diagnostic to measure tumor mutational burden.

The FDA approved Bristol Myers Squibb’s ozanimod (Zeposia) 0.92 mg as an oral treatment for relapsing forms of multiple sclerosis (RMS). Ozanimod can be used to treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.