Product Approvals and Launches

The liquid serum assay was cleared for use as a companion diagnostic for olaparib to identify patients with BRCA1/2- and/or ATM-mutated metastatic castration-resistant prostate cancer.

For multiple sclerosis, the therapy will be sold as Kesimpta by Novartis; it is administered by patients once a month through the Sensoready autoinjector pen.

Satralizumab is the third drug to be approved by the FDA for neuromyelitis optica spectrum disorder (NMOSD).

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.