Wednesday, March 29, 2017 3:01:26 PM
"The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Keytruda’s benefits are greater than its risks and recommended that it be approved for use in the EU."
"The CHMP considered that available study results, although not final, consistently showed the benefits of Keytruda in patients with advanced melanoma. The safety profile was considered favourable compared with other treatment, including ipilimumab and chemotherapy, and side effects appear manageable."
"With respect to NSCLC, the CHMP noted that Keytruda helps prolong survival and slows the worsening of the disease. The safety profile of Keytruda in lung cancer patients is similar to that in melanoma patients and its overall safety compares well with that of chemotherapy."
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