Pfizer Receives FDA Approval For Xalkori

Pfizer has received the approval of the FDA for its drug, Xalkori for lungs cancer treatment

Pfizer Inc. has received good news this Friday from the Food and Drug Administration, who has approved xalkori, which is meant for non-small rare type of lung cancer. The medicinal company can now create this drug, which will be the first one ever for this genetic and rare non-small lung cancer.  

The pharmaceutical company might be capable to make change by giving patients a treatment choice that they did not have before though manufacturing and researching xalkori. This drug consists of MET, ROS1 and ALK and was initially approved for curing ALK-positive NSCLC back in 2012. The desperate need for the treatment of this type of cancer is why the FDA reviewed the drug and gave the approval rapidly. A second name for xalkori is crizotinib, and is going to provide treatment to conditions that did not have any cures before.

ROS-1 gene problem can cause abnormal cells to develop in the body, and happens mainly because of attachment of ROS1 to other genes of the human body, causing malfunction in the functionality of other genes.  Approximately 1.5 million People are diagnosed with NSCLC each year and only 15,000 are caused by ROS1. The director of Hematology and Oncology Products at FDA, Dr. Richard Pazdur believes that his manufacturing and usage of xalkori is going to help provide a solution to patients who are diagnosed with this rare ROS1 gene mutation and lung cancer.

This life saving drug, xalkori is from the class, kinase inhibitors and got the first approval in 2011, but for treating metastatic NSCLC. This approval was the first one ever for the ALK in the United States and was used to treat almost 8,000 patients. The recent approval received by Pfizer Inc. for xalkori was attained earlier than expected, which was April this year.

A study was conducted by a center, single-arm initial phase on approximately 50 patients in order to determine the response rate of the drug such as the amount that was given to the patients of the drug and monitoring the moves of the cancer upon consumption as to whether it was shrinking completely or at a minor level. The study showed impressive results with 66% of the patients showing complete or shrinkage to a certain extent of the tumors.

Xalkori is going to cost Pfizer an amount of $14,336 each month with sales of $488 million annually, which is going to be an asset for the profits of the company. Many analysts believe that it might become a blockbuster product of the pharma giant by 2020 and has forecasted to make $2 billion in yearly sales. The FDA has approved three inhibitors including xalkori, Zykadia and Alecensa. Xalkori is already undergoing reviews by the European Medicines Agency for expansions of labels and approval of ROS1 mutation. This drug might just become the bread and butter of the pharmaceutical organization in the future.