NEW JERSEY - The U.S. Food and Drug Administration (FDA) has given the green light to Merck & Co for the expanded use of its blockbuster drug Keytruda, now approved to treat patients with advanced cervical cancer. This decision comes on the heels of a successful late-stage trial where Keytruda showed a significant 41% reduction in the risk of disease progression or death when compared to the standard chemoradiotherapy.
The FDA's approval today further extends to sanctioning Keytruda in combination with CRT for initial treatment of FIGO Stage III-IVA cervical cancer across all PD-L1 expression statuses. This authorization, based on data from KEYNOTE-A18, not only showcased an enhanced PFS but also confirmed the previously reported significant risk reduction of disease progression or death compared to placebo plus CRT.
With this approval, Keytruda can be used for patients with cervical cancer at FIGO Stage III-IV, which represents a more advanced and difficult-to-treat stage of the disease. Moreover, this authorization constitutes Keytruda's third for cervical cancer and its overall 39th in the US market. The drug, which is already a key player in Merck's oncology portfolio, has further cemented its position as a leading therapy in cancer treatment, including its role in advanced-stage care and now introducing it earlier in the disease course.
However, it's worth noting that this new usage comes with potential immune-mediated side effects like pneumonitis. Despite these potential side effects, Dr. Aktan from Merck acclaimed this advancement for anti-PD-1 therapy protocols targeting newly diagnosed patients.
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