Lung Cancer Drug Alecensa Gets Green Light From FDA
Alecensa, an experimental drug by Genentech has been greenlighted by the US Food and Drug Administration because it has been found to cure non-small lung cancer in patients.
Alecensa (alectinib) has been approved by the Food and Drug Administration (FDA) to treat people with anaplastic lymphoma kinase (ALK)-positive, metastatic and progressive non-small cell lung cancer (NSCLC) and those who cannot take crizotinib. The drug is made by Genentech, a member of the Roche Group.
"Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib," said Dr. Sandra Horning, chief medical officer of Global Product Development. "Sixty percent of people enrolled in our studies had tumors that had spread to their central nervous systems, and Alecensa shrank tumors in many people in a subset of patients with CNS disease."
But like many drugs, it comes with serious side effects. According to Street Insider, it may include slow heartbeat, muscle pain, liver problems, weakness, lung problems and tenderness. The more common side effects of taking Alecensa are constipation and swelling in ankles, eyelids, hands and feet.
Tech Times report that the manufacturing company has been given a conditional approval. Genetech must conduct more testings to show the benefits of the drug. They were also tasked to find out how Alecensa can lengthen patient survival rates against Xalkori, a drug competitor.
In one of the clinical trials that accelerated Alecensa for approval from the FDA, it reduced the tumors in 38 percent of the 87 patients in the study. The shrinkage went on for about 7 months. In another study with patients that previously had Xalkori, Alecensa shrunk the lung tumors of 44 percent of 138 patients.
The drug was also tested on tumors that have spread on the brain which can occur in these cases. The researchers found that it helped reduce the tumor as well.
"In addition to the primary effect on tumors in the lung, Alecensa clinical trials provide evidence of an effect on tumors that had spread to the brain, which is an important effect," said Dr. Richard Pazdur, director of the Hematology and Oncology department of the FDA, via Main News Online.
The drug will be available in the United States within two weeks. Genentech will be having a patient assistance program through Genentech Access Solutions for patients who are qualified to take the drug. More information can be found at their website: https://www.genentech-access.com/