Merck & Co Inc. said on Tuesday that the U.S. Food and Drug Administration approved its immunotherapy Keytruda as a treatment for an early form of tough-to-treat breast cancer in combination with chemotherapy. The FDA approval is for treating triple-negative breast cancer (TNBC), an aggressive form of the disease with an increased risk of recurrence. Trial data from over 1,000 patients showed that the drug, in combination with chemotherapy before surgery and then used as monotherapy after surgery, helped prolong the time that a patient remained free of cancer. The combination therapy is the first time that a treatment regimen using immunotherapy has been approved for patients with early-stage TNBC. The nod comes a few months after the FDA declined to approve the drug for these cancer patients, after an expert panel recommended that a decision on approval should be delayed until more data was available. Keytruda has been racking …
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