Merck & Co Inc. announced on Tuesday that the US Food and Drug Administration has approved the immunotherapy Keytruda for the treatment of early-stage breast cancer that is difficult to treat in combination with chemotherapy.
FDA approval concerns the treatment of aggressive forms of triple-negative breast cancer (TNBC) at high risk of recurrence.
According to study data from more than 1,000 patients, the drug is used as a post-surgery monotherapy in combination with pre-surgery chemotherapy to help patients stay cancer-free for longer periods of time. I did.
Combination therapy is the first time a treatment regimen using immunotherapy has been approved for early-stage TNBC patients.
Nods after months after the FDA refused to approve drugs for these cancer patients, after an expert committee recommended that approval decisions should be postponed until more data are available. come.
Keytruda has received approval to treat several types of cancer, with sales of this drug surpassing that of rival immunotherapies performed by Bristol Myers Squibb and Roche.
Keytruda, which is currently approved for the treatment of 30 cancers in the United States, reached $ 14.4 billion in sales in 2020.
Approximately 10% to 15% of breast cancer patients are diagnosed with TNBC. This is common among African-American people under the age of 40.