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The safety profile of denosumab in oncology beyond the safety of denosumab as an anti-osteoporotic agent: still more to learn
- Source :
- Expert opinion on drug safety. 20(2)
- Publication Year :
- 2020
-
Abstract
- Initially endorsed as an antiosteoporotic agent, denosumab ‒ human monoclonal antibody inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL)‒ has currently shown an anticancer potential, rationalizing its exploitation in oncology. A prerequisite for leveraging denosumab in oncology is a favorable safety profile.The present review provides an overview of the adverse events of denosumab in oncology, with a focus on hypocalcemia, medication-related osteonecrosis of the jaw, atypical femoral fracture(s), post-denosumab vertebral fractures, increased risk of infections, and excess of second primary cancer. Representative studies addressing the safety and efficacy of denosumab compared to bisphosphonates in oncology are summarized. Critical gaps in the literature concerning the safety of denosumab in oncology are highlighted as opposed to plenty of available safety data on denosumab as an antiosteoporotic agent.Despite the generally acceptable safety profile of denosumab in oncology, many issues remain unresolved. Further research is mandatory to counteract current challenges, namely: (i) validation of risk factors for adverse events; (ii) elucidation of the pathophysiology of the adverse events in search of actionable molecular pathways; (iii) illumination of the association of denosumab with increased risk of infections and/or second primary cancer; (iv) establishment of optimal diagnostic, and therapeutic protocols.
- Subjects :
- Oncology
medicine.medical_specialty
medicine.drug_class
Antineoplastic Agents
030204 cardiovascular system & hematology
Monoclonal antibody
03 medical and health sciences
0302 clinical medicine
Risk Factors
Internal medicine
Neoplasms
medicine
Animals
Humans
Pharmacology (medical)
Receptor
biology
Bone Density Conservation Agents
Diphosphonates
business.industry
Activator (genetics)
General Medicine
medicine.disease
Ligand (biochemistry)
Safety profile
Denosumab
RANKL
030220 oncology & carcinogenesis
biology.protein
Osteoporosis
Osteonecrosis of the jaw
business
medicine.drug
Subjects
Details
- ISSN :
- 1744764X
- Volume :
- 20
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Expert opinion on drug safety
- Accession number :
- edsair.doi.dedup.....5cbfea393fad19c459789231ecfde4c9