From the article:
Italian drugmaker Menarini has succeeded where three European Big Pharmas have failed, pushing the first oral selective estrogen receptor degrader (SERD) to treat breast cancer across the FDA finish line.
The agency has signed off on Orserdu (elacestrant) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
AZ released an injectable SERD in 2002, and Roche, AZ and Sanofi had failed trials of their oral SERD. The approval for Menarini also comes with an approval for a companion diagnostic.
In an age where biologics, gene and cell therapies are growing, it is nice to see that oral drugs are still achieving approvals. The companion diagnostic also shows the continued value of targeting the right patients to achieve success and not treat patient who will not respond.
No comments:
Post a Comment