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Keytruda's first FDA approval Keytruda (pembrolizumab) received its initial FDA approval on September 4, 2014, for the treatment of unresectable or metastatic melanoma. When did Keytruda expand into other cancers? After the 2014 melanoma approval, Keytruda gained indications across multiple tumor types. It now holds approvals for lung, head and neck, bladder, and kidney cancers, plus microsatellite instability-high tumors and many more. How does Keytruda compare with Opdivo? Keytruda and Opdivo (nivolumab) belong to the same PD-1 inhibitor class. Both share similar indications and salaries, but Keytruda has broader approvals in certain areas like triple-negative breast cancer and endometrial cancer. Opdivo often covers more classical pathways in lung and kidney. Why are companies challenging Keytruda's patents? Firms such as Celltrion and others are challenging Keytruda's patents to launch biosimilars earlier. Patent disputes center on formulation and manufacturing methods rather than the active ingredient itself.
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