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 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 a
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 an 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 is
available.
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 Keytruda has been racking up
approvals for treating several types of cancers
and the drug's sales have eclipsed those of
rival immunotherapies made by Bristol Myers
Squibb and Roche.
Sales of Keytruda, now approved in the United
States to treat 30 types of cancer, reached
$14.4 billion in 2020.
Roughly 10-15% of patients with breast cancer
are diagnosed with TNBC, which is more common in
people below 40 years of age and who are African
American.
(Reporting by Manas Mishra in Bengaluru; Editing
by Shailesh Kuber)
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