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[34] [35] In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma. [36] In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of people with multiple myeloma who have received at least one prior therapy ...
Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody, more specifically a PD-1 inhibitor, used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer.
It was approved for use in the United States in May 2020. [2] [7] [8]Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV). [2]
This makes Keytruda plus chemoradiotherapy the first anti-PD-1-based immunotherapy combination approved in the U.S. as a treatment for newly diagnosed patients with a certain type of cervical ...
The approval marks the first indication for Keytruda in MPM in the U.S. Also Read: Merck/Daiichi Sankyo Partnered Lung Cancer Candidate Meets Primary Goal In Late-Stage Study. MPM is a rare ...
The U.S. health regulator's approval extends Keytruda's use in combination with chemotherapy as a treatment given before surgery to shrink the size of the tumor in patients. The U.S. drugmaker is ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
Merck's (MRK) Keytruda gets FDA approval for primary mediastinal B-cell lymphoma (PMBCL) - its second label expansion approval this week.