Nerlynx (neratinib) vs Talzenna (talazoparib)

Nerlynx (neratinib) and Talzenna (talazoparib) are both targeted therapies used in the treatment of certain types of breast cancer, but they work in different ways and are used in different contexts. Nerlynx is a tyrosine kinase inhibitor that specifically targets HER2-positive breast cancer to prevent the cancer cells from growing, and is often used as an extended adjuvant treatment following initial therapy with trastuzumab. In contrast, Talzenna is a PARP inhibitor used for the treatment of HER2-negative breast cancer in patients who have inherited BRCA mutations, functioning by exploiting the cancer cells' already compromised DNA repair mechanism to prevent their growth. Patients should consider their specific type of breast cancer, genetic makeup, and previous treatments when deciding between these medications, in consultation with their oncologist.

Difference between Nerlynx and Talzenna

Metric	Nerlynx (neratinib)	Talzenna (talazoparib)
Generic name	neratinib	talazoparib
Indications	Extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy	Treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer
Mechanism of action	Irreversible inhibitor of HER2 and epidermal growth factor receptor (EGFR) kinases	Poly (ADP-ribose) polymerase (PARP) inhibitor, which induces synthetic lethality in BRCA1/2-deficient tumor cells
Brand names	Nerlynx	Talzenna
Administrative route	Oral	Oral
Side effects	Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT elevation, nail disorders, dry skin, abdominal distention, weight loss, urinary tract infection	Anemia, neutropenia, thrombocytopenia, fatigue, nausea, headache, diarrhea, vomiting, alopecia, decreased appetite, PALB2 mutation-associated breast cancer, myelodysplastic syndrome, acute myeloid leukemia
Contraindications	None known	None known
Drug class	Tyrosine kinase inhibitor	Poly (ADP-ribose) polymerase inhibitor
Manufacturer	Puma Biotechnology, Inc.	Pfizer Inc.

Efficacy

Nerlynx (neratinib) Efficacy in Breast Cancer

Nerlynx (neratinib) is an oral medication that has been approved by the U.S. Food and Drug Administration (FDA) for the extended adjuvant treatment of adult patients with early-stage, HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Clinical trials have demonstrated the efficacy of neratinib in reducing the risk of breast cancer recurrence. In a pivotal phase III clinical trial known as ExteNET, patients who received neratinib after standard adjuvant therapy with trastuzumab had a statistically significant improvement in invasive disease-free survival (iDFS) compared to those who received placebo.

However, it is important to note that the benefit of neratinib varies based on hormone receptor status. The greatest benefit was observed in patients with hormone receptor-positive, HER2-positive breast cancer. In this subgroup, neratinib showed a further reduction in the risk of recurrence, suggesting that this medication can be particularly effective in this population. The treatment duration in the ExteNET trial was one year, and the positive effects of neratinib on iDFS were observed despite its association with side effects, most notably diarrhea.

Talzenna (talazoparib) Efficacy in Breast Cancer

Talzenna (talazoparib) is another oral medication approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. The approval of talazoparib was based on the EMBRACA trial, a phase III clinical study that demonstrated a significant improvement in progression-free survival (PFS) in patients receiving talazoparib compared to those receiving standard chemotherapy.

In the EMBRACA trial, talazoparib not only improved PFS but also showed a higher overall response rate (ORR) compared to chemotherapy. This suggests that talazoparib is an effective treatment option for patients with BRCA-mutated breast cancer. Additionally, talazoparib has been associated with an improvement in patient-reported outcomes, indicating a potential benefit in quality of life. While talazoparib provides a promising treatment avenue for a specific subset of breast cancer patients, it is essential to ensure appropriate patient selection through genetic testing for BRCA mutations.

Regulatory Agency Approvals

Nerlynx

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

Talzenna

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

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