Amgen Inc. (formerly Applied Molecular Genetics Inc.) is one of the world’s largest independent biotechnology companies established at Thousand Oaks, California, in 1980.
- In Feb 2021, U.S. FDA granted Priority Review for Sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.
- In 2017, US FDA approved IMLYGIC® (talimogene laherparepvec) a first-in-class, genetically modified, herpes simplex virus type 1–based oncolytic immunotherapy, for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Talimogene laherparepvec is the first US-approved oncolytic virus.
- In July 2015, U.S. FDA approved the supplemental New Drug Application (sNDA) for Kyprolis® (carfilzomib) for Injection in combination with Revlimid® and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy. Kyprolis is also approved for use in Argentina, Israel, Mexico and Thailand.
- In Dec 2014, U.S. FDA granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). With this approval, BLINCYTO becomes the first FDA-approved bispecific CD19-directed CD3 T-cell engager (BiTE®) antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B-cell precursor ALL, a rare and rapidly progressing cancer of the blood and bone marrow.
- On Jun 2013, FDA approved Denosumab / XGEVA® for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
- On Sept 16, 2011, FDA approved Denosumab / Prolia®, as a treatment to increase bone mass in patients who are at high risk of fracture from receiving ADT for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer.
- In Sep 2006, Panitumumab / Vectibix™, was approved by FDA for the treatment of EGFR-expressing metastatic colorectal cancer.
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