US FDA approved new drug Bavencio that contains active pharmaceutical ingredient avelumab therapeutically categorized as anti-PD-L1 IgG1 monoclonal antibody for the treatment of merkel cell carcinoma (MCC) a rare kind of skin carcinoma in adults and pediatrics.This is first kind of treatment as immunotherapy approved by US FDA for the treatment of MCC.
Though, merkel cell carcinoma is a rare kind of skin carcinoma but it is one of the most aggressive form of skin disorders. Merkel cell carcinoma is also characterized as cutaneous APUDoma. Exact underlying cause is still unclear to somehow but many researchers strongly believed that merkel cell polomavirus (MCV) is one of the leading causes of MCC. According to a statistics about 80% of merkel cell carcinoma are somewhere connected with polyomavirus while 20% of MCC cases are still unknown as far as the underlying mechanism is concerned. This virus was first discovered in 2008 by a team of scientists at University of Pittsburgh.
Clinically this carcinoma is classified as neuroendocrine tumor and common manifestations of this tumor are small painless nodular mass projected upward and can be seen through naked eye. Mot of the times,they are brown to reddish or flesh colored tumors ranges from 0.5cm to 5cm in diameter.
Bavencio/avelumab Side effectsAccording to data obtained from health authorities this drug exhibit some side effects during clinical trails there were mild to moderate or some were severe kind of reactions. Detail of these side effects is as follows
- Asthenia (general weakness)
- Muscular aches
- Loss of appetite
- Swelling in extremities
- Edematous condition
- Immune system hypersensitivity
- liver inflammation
- Endocrine disorders
- Infusion related reactions
Bavencio/avelumab Uses/Prescribing InformationUS FDA approved this drug for the treatment of rare but highly progressive for of skin carcinoma known as metastatic merkel cell carcinoma in adults and children having age 12 years old or more than that. This is first kind of immunotherapy approved by US FDA for the treatment of MCC.
Bavencio/avelumab DosageBavencio/avelumab is administered in the form parenteral solution (intravenously). It's standard dosage frequency is 10mg/Kg after every 2 weeks in adults and children having age 12 years or more. This therapy continues for a long term to revert the progression of disease. In case of severe side effects or unacceptable toxicity drug should be discontinued and immediately consult with your health care provider.
This drug is administered by your healthcare practitioner (HCP), which usually means:
- It may comes under special items category.
- You cannot fill this prescription in a regular pharmacy. Your doctor, hospital, or clinic will provide this medication because of possible complications or other issues.
- This drug is likely to be covered under your medical benefit if you have insurance.