Amgen invented the BiTE T-cell engager format and the first KRAS inhibitor.
Amgen, based in Thousand Oaks, California, and listed as AMGN, invented the BiTE T-cell engager format and made the first KRAS inhibitor. Its oncology portfolio includes blinatumomab, tarlatamab, the first solid-tumour T-cell engager to show an overall survival benefit, sotorasib, bemarituzumab against FGFR2b, xaluritamig, a STEAP1 by CD3 engager, the oncolytic virus Imlygic, and supportive care products including denosumab and darbepoetin alfa. OnCo links it to the AALL1731 and E1910 blinatumomab papers, to CodeBreaK 200 and CodeBreaK 300 for sotorasib, to DeLLphi-301 for tarlatamab, to PRMT5 in MTAP-deleted cancers, to the KIF18A idea, and to the bottleneck of wrong doses. Whether T-cell engagers can work in common solid tumours beyond small-cell lung cancer is the open question. Each product has its own page.
Blinatumomab was the first T-cell engager (2014), and is now given to children and adults with leukaemia even when in remission, because it improves survival.
The first T-cell engager to improve survival in a common solid tumour, small-cell lung cancer.
Sotorasib (Lumakras) was the first drug to hit KRAS, approved in 2021 after four decades of failure.
Talimogene laherparepvec (T-VEC, Imlygic) was the first approved oncolytic virus (2015), injected into melanoma skin lesions.
Anvumetostat is an experimental small-molecule drug from Amgen in phase 2 trials for non-small-cell lung cancer, aimed at PRMT5 (MTAP-deleted cancers).
Cinacalcet is a tablet that quiets overactive parathyroid tissue, approved in 2004 and labelled for the dangerous high calcium levels of parathyroid carcinoma, a rare cancer where surgery often cannot remove all the hormone-producing tissue.
Bemarituzumab is an antibody against FGFR2b, a growth receptor overproduced in about a third of stomach cancers. It improved survival early in its phase 3 trial, but the gain faded with longer follow-up.
Carfilzomib is a second-generation proteasome inhibitor with less nerve damage but more heart and blood-pressure effects.
Darbepoetin alfa (Aranesp) is a longer-acting version of erythropoietin given every one to three weeks to treat anaemia caused by chemotherapy, reducing transfusions but with the same warnings about clots and tumour growth as epoetin.
Denosumab is an injection under the skin that blocks the signal driving bone breakdown. As Xgeva it prevents fractures and other bone complications in people whose cancer has spread to bone or who have myeloma; as Prolia it treats osteoporosis, including bone loss caused by hormone therapy for breast and prostate cancer.
Epoetin alfa is a manufactured version of the kidney hormone that tells the bone marrow to make red blood cells. In cancer it treats anaemia caused by chemotherapy and reduces the need for transfusions, but it is used cautiously because it can shorten survival and cause clots.
Filgrastim (Neupogen and its biosimilars) is a daily injection that speeds the recovery of infection-fighting white cells after chemotherapy, lets doctors give chemotherapy on schedule and mobilises stem cells for transplant.
Panitumumab is a fully human EGFR antibody, the preferred first-line partner for chemotherapy in left-sided, RAS-normal bowel cancer after the PARADIGM trial.
Pegfilgrastim (Neulasta) is a long-acting form of the growth factor G-CSF, given once per chemotherapy cycle to speed white cell recovery and prevent febrile neutropenia; one dose replaces about eleven daily filgrastim injections. Biosimilars have been sold since 2018 and the Onpro on-body injector delivers it automatically the day after chemotherapy; bone pain is the main side effect.
Romiplostim is a weekly injection that tells the bone marrow to make more platelets; it is approved for immune thrombocytopenia and for radiation injury, and is being tested for the low platelets that chemotherapy causes.
Xaluritamig is Amgen's T-cell engager for prostate cancer, now in two phase 3 trials, aiming to do for prostate cancer what tarlatamab did for small-cell lung cancer.
AALL1731 brings immunotherapy into the front-line treatment of the commonest childhood cancer, in the group of children where most relapses were occurring despite good initial risk. Blinatumomab was approved for this use in 2024 and paediatric protocols worldwide are being amended. Whether it can allow less chemotherapy, and its effect on very low-risk children, are the next questions.
E1910 changed the standard of care for adult B-ALL: immunotherapy is now part of front-line consolidation even for patients with no detectable leukaemia, because MRD-negative by flow cytometry does not mean cured. It also demonstrated that a T-cell engager can improve overall survival in a curative setting. Chemotherapy-light or chemotherapy-free regimens built on blinatumomab and inotuzumab are the next step.
Patients with KRAS G12C lung cancer that has progressed after chemo-immunotherapy can take an oral KRAS inhibitor instead of docetaxel and gain a somewhat longer time to progression with fewer severe side effects, but should understand that most tumours become resistant within a year and that survival is not improved. KRAS G12C testing is worthwhile, but first-generation inhibitors are a step rather than a cure; combinations and next-generation inhibitors are the active research fronts.
Patients with metastatic colorectal cancer carrying a KRAS G12C mutation (about 3-4% of cases) who have exhausted standard chemotherapy now have a targeted option that works far better than trifluridine-tipiracil or regorafenib. The higher sotorasib dose is clearly superior, and the EGFR antibody is essential because KRAS inhibition alone has little effect in bowel cancer. Responses are still modest and short-lived compared with EGFR or ALK inhibitors in lung cancer.
Patients with small-cell lung cancer that has relapsed after chemotherapy now have a drug that works far better than topotecan or lurbinectedin, and it is the first T-cell engager approved for a solid tumour. Treatment requires inpatient monitoring for the first doses because of cytokine release syndrome, which most centres now manage on a short-stay basis. It does not yet apply to first-line treatment, where trials are ongoing.
This is the approval that created the class, and it is also the clearest example of how the class is oversold. A durable response rate eight times the comparator is a real local effect on injectable lesions. The survival comparison did not reach significance, and the comparator was granulocyte-macrophage colony-stimulating factor rather than a checkpoint inhibitor, which by 2015 was already the standard. A reader told that a virus improves survival in melanoma is being told something this trial did not show.
Extended RAS testing (KRAS and NRAS exons 2, 3 and 4) became the standard before any EGFR antibody, and about one in six patients who would previously have been treated is now spared a drug that would have made things worse.
Shares A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC, Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment, A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL, Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC).
Shares CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer, CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, KRAS G12C-mutant pancreatic ductal adenocarcinoma.
Shares CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer, CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, KRAS G12C-mutant pancreatic ductal adenocarcinoma.
Shares TOWER, Xaluritamig, Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL, ECOG-ACRIN E1910: adding blinatumomab to chemotherapy for adults with B-cell ALL already in MRD-negative remission.
Shares DeLLphi-304, CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer, Limited-stage small-cell lung cancer.
Shares Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal, CodeBreaK 300, CodeBreaK 300: sotorasib plus panitumumab in chemotherapy-refractory KRAS G12C colorectal cancer, Panitumumab.
Shares DeLLphi-305, DeLLphi-304, DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer, Tarlatamab.
Shares CodeBreaK 200, CodeBreaK 200: sotorasib versus docetaxel in KRAS G12C-mutated lung cancer, a modest win for the first KRAS drug, Sotorasib, KRAS G12C-mutant non-small-cell lung cancer.