Afinitor (everolimus) vs Nerlynx (neratinib)

Afinitor (everolimus) is an mTOR inhibitor primarily used to treat certain types of cancers such as advanced renal cell carcinoma, certain breast cancers, and neuroendocrine tumors, as well as to prevent organ rejection in transplant patients. Nerlynx (neratinib), on the other hand, is a tyrosine kinase inhibitor specifically indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. The choice between Afinitor and Nerlynx would depend on the specific type and stage of cancer a patient has, as well as their individual medical history and the recommendation of their oncologist, as these medications are not interchangeable and target different pathways in cancer treatment.

Difference between Afinitor and Nerlynx

Metric	Afinitor (everolimus)	Nerlynx (neratinib)
Generic name	Everolimus	Neratinib
Indications	Advanced hormone receptor-positive, HER2-negative breast cancer, advanced neuroendocrine tumors, renal cell carcinoma, tuberous sclerosis complex-associated seizures, subependymal giant cell astrocytoma (SEGA), and renal angiomyolipoma	Extended adjuvant treatment of early-stage HER2-positive breast cancer
Mechanism of action	mTOR inhibitor that inhibits the mammalian target of rapamycin (mTOR), a serine-threonine kinase	Tyrosine kinase inhibitor that irreversibly binds to and inhibits the epidermal growth factor receptor (EGFR) family of tyrosine kinases
Brand names	Afinitor, Afinitor Disperz, Zortress	Nerlynx
Administrative route	Oral	Oral
Side effects	Mouth ulcers, infections, rash, fatigue, diarrhea, decreased appetite, edema, stomatitis, pneumonitis, hyperglycemia, etc.	Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, etc.
Contraindications	Hypersensitivity to everolimus or other rapamycin derivatives	Hypersensitivity to neratinib or any component of the formulation
Drug class	mTOR inhibitor	Tyrosine kinase inhibitor
Manufacturer	Novartis	Puma Biotechnology

Efficacy

Afinitor (Everolimus) Efficacy in Breast Cancer

Afinitor, known generically as everolimus, is a medication that has been shown to be effective in the treatment of hormone receptor-positive, HER2-negative breast cancer. This type of cancer is characterized by the presence of hormone receptors but lacks the HER2 protein. Afinitor works by inhibiting the mammalian target of rapamycin (mTOR), a protein that plays a critical role in the growth and proliferation of cancer cells. In combination with exemestane, a type of hormone therapy, Afinitor has been found to significantly extend progression-free survival in patients with advanced breast cancer who have previously undergone treatment with letrozole or anastrozole.

The efficacy of Afinitor in breast cancer was highlighted in the BOLERO-2 clinical trial, where it was demonstrated that the addition of everolimus to exemestane therapy resulted in a median progression-free survival of 7.8 months compared to 3.2 months with exemestane alone. This marked improvement has made Afinitor a valuable option for patients with this subtype of breast cancer, particularly those who have become resistant to initial hormone therapies.

Nerlynx (Neratinib) Efficacy in Breast Cancer

Nerlynx, with the generic name neratinib, is an oral medication approved for the extended adjuvant treatment of HER2-positive early-stage breast cancer. For patients who have completed one year of trastuzumab-based adjuvant therapy, Nerlynx offers a continued treatment approach aimed at reducing the risk of cancer recurrence. As a tyrosine kinase inhibitor, Nerlynx specifically targets the HER2 protein receptor, which is overexpressed in HER2-positive breast cancers and promotes the growth of cancer cells.

The efficacy of Nerlynx in reducing the risk of breast cancer recurrence was demonstrated in the ExteNET trial, which included women with HER2-positive early-stage breast cancer. The study showed that after two years, 94.2% of patients treated with Nerlynx did not experience breast cancer recurrence compared to 91.9% of patients who received the placebo. This improvement in disease-free survival establishes Nerlynx as an important therapeutic option for patients looking to decrease the likelihood of breast cancer returning after initial treatment with trastuzumab.

Regulatory Agency Approvals

Afinitor

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Therapeutic Goods Administration (TGA), Australia

Nerlynx

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada
Therapeutic Goods Administration (TGA), Australia

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