March 15 (Reuters) - Merck ( MRK ) said on Friday its
blockbuster immunotherapy Keytruda, in combination with
chemoradiotherapy, met the main goal of improving overall
survival for newly diagnosed patients with a form of cervical
cancer in a late-stage study.
The U.S. Food and Drug Administration had in January
approved the expanded use of the combination to treat patients
who have advanced cervical cancer and had not previously
received surgery, radiation or systemic therapy.
The January approval was based on a late-stage study where
the drug combination reduced the risk of cancer progression or
death but had not shown clinically meaningful improvement in
overall survival when compared to chemotherapy alone.
The Keytruda combo has been approved for two indications
related to the treatment of cervical cancer.
Cervical cancer, which forms in the cells lining the cervix,
is the fourth most common cancer in women globally, according to
the World Health Organization.