The incidence of adverse effects in Alecensa is 80%

The Ministry of Food and Drug Safety inquired about opinions by the 18th to change the permission

A five-year post-marketing survey (PMS) of the Anaplastic Lymphoma Kinase (ALK) mutant non-small cell lung cancer treatment Alecensa 150mg showed 1012 significant drug abnormalities that could not rule out causality.

 

The permit will be changed with 20 and 122 cases of serious drug adverse reactions and unexpected drug adverse reactions that cannot be excluded from causal relationships, respectively.

 

The Ministry of Food and Drug Safety announced that it will prepare an order (proposal) to change the permission based on the results of the investigation after marketing Alecensa in Roche Korea and conduct an opinion inquiry until the 19th.

 

Eisai Korea obtained an item license for Fycompa film coated tab on July 10, 2015.

 

Alecensa received a domestic item license in October 2016 for the treatment of ALK-positive local progressive and metastatic non-small cell lung cancer patients who had been treated with Xalkori.

 

After expanding the indication to primary treatment in 2018, Alecensa sales exceeded Xalkori, which is 20.3 billion won, from 10.4 billion won in 2018 to 22.1 billion won in 2019.

 

Since then, it has expanded to 29.3 billion won in 2020 and 32.7 billion won in 2021.

 

As a result of a five-year post-marketing survey of 345 people under the patient registration program in Korea, the expression rate of abnormal cases was reported to be 80.29% (277/345 cases, a total of 1012 cases), regardless of causality.

 

Among them, 4.64% (16/345 people, 20 cases) of serious drug abnormalities were reported, including mouth inflammation, increased blood bilirubin, increased blood creatine phosphorylase, increased blood creatinine, peripheral edema, fever, and death.

 

Unexpected drug abnormalities such as decreased red blood cell volume rate decreased red blood cell count, joint pain, muscle weakness, dizziness, and nephropathy were found to be 24.06% (83/345 cases, 122 cases).

 

The Ministry of Food and Drug Safety plans to change the permit after hearing opinions on the change order.