US FDA approved new drug Nerlynx that contains neratinib as active pharmaceutical ingredient as extended adjuvant treatment of early-stage, HER2-positive breast cancer. This is first kind of therapy approved by FDA as an adjuvant treatment along with primary treatment ( trastuzumab therapy) to reduce the risk of breast cancer recurrence.
Breast cancer is one of the leading cause of death in females due to cancer. Initially, it appears as a lump inside the breast that growth with the passage of time and reaches to progressive metastatic stage. There are no obvious symptoms at initial stages that makes it hard to diagnose earlier. Later on patient may feel bone pain, swollen lymph nodes, fatigue, shortness of breath and mild fever in some cases also been reported.
Exact underlying mechanism that causes breast cancer is sill not yet clear to somehow but some important risk factors that play important role in pathophysiology of breast cancer are obesity, alcohol consumption, smoking, HRT (hormone replacement therapy), early menopause and family history more specifically.
People having cases of breast cancer in their family history especially inherited mutations in gene BRCA1 and BRCA2 have high risk of developing breast cancer in their later ages. So, regular screening for breast cancer in very beneficial for such candidates.
Nerlynx/neratinib belongs to a therapeutic class termed as tyrosine kinase inhibitors. Pharmacologically, it binds with side chain of cysteine and inhibits epidermal growth factor receptor and human epidermal growth factor 2. Nerlynx/neratinib is used as adjuvant treatment along with primary treatment to decrease the cancer progression and its recurrence.
Nerlynx/neratinib Side effects
According to health authorities following side effects were observed during its clinical trials
- Abdominal Pain
- Loss of appetite
- Swelling of mucosa
- Muscular weakness and spasm
- Increase in liver enzymes
- Weight loss
- Skin rashes
- Hypersensitivity reaction
Nerlynx/neratinib Uses/Prescribing Information
US FDA indicated this drug as extended adjuvant treatment of early-stage, HER2-positive breast cancer. It is used to reduce the progression of diseases as well as cancer recurrence. This is first kind of therapy approved US FDA as extended adjuvant therapy for the treatment of breast cancer.
This drug is formulated as tablet for oral administration with potency of 40mg. However, standard dosage frequency of this drug is 240mg orally with food daily for one year. In case of renal or hepatic impairment dose titration should be considered or in case of toxicity it's administration should be discontinued.