Pfizer Inc. (NYSE:PFE) XALKORI (Crizotinib) Granted FDA Breakthrough Therapy Authorization In Two New Indications


Pfizer Inc. (NYSE:PFE) has made an announcement that the U.S Food and Drug Administration (FDA) granted a Breakthrough Therapy status to for XALKORI.

XALKORI which is the first ever Tyrosine Kinase Inhibitor to receive the designation is used to treat patients who have been previously treated with MET Exon 14 Alterations for Metastatic Non-Small Cell lung cancer. The Breakthrough Therapy designation for XALKORI was, additionally granted for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive.

Met 14 alterations

Met is a type of transmembrane tyrosine receptor kinase carried in various cell types. Met 14 alterations are found in about 3% of NSCLC tumors. ALCL which is a rare non-Hodgkin lymphoma is categorized into either ALK-positive or ALK-negative. Even with chemotherapy, many patients with ALCL are prone to relapse hence the need for alternative treatment.

With several patients suffering from cancers that carry these genomic alterations XALKORI is a welcome relief as it promises to transform the lives of the said patients. A biomarker-driven approach like XALKORI is changing cancer treatment methods by ensuring patients get the right medicine for their cancer disease.

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Following FDA’s approval test, XALKORI is currently approved in the U.S metastatic NSCLC patients whose tumors are ALK-positive. Since being approved it has become a first-line general care for ALK-positive NSCLC. Although it is already approved by FDA for treatment of both ALK-positive and ROS1 positive, if approved in treating patients with metastatic NSCLC with MET exon 14 alterations, then XALKORI will become the only tyrosine kinase indicator with proven efficiency in three different NSCLC’s Biomarker-driven indications.

XALKORI’s potential is promising in the treatment of Lung cancer which is not only difficult to treat but also the leading cause of cancer deaths in the world. It is proven that most NSCLC patients diagnosed late with metastatic.

During clinical trials, XALKORI just like any other drug was found to have several side effects. Some very minor like, hepatoxicity, pneumonitis, severe visual loss were found in patients. Bradycardia was found to be moderately severe in patients while vision disorder was the most prevalent side-effect in patients.

In relation to ALK-positive NSCLC, XALKORI has been approved in more than 90 countries such as Japan, China, Australia, Canada, the EU among others. Whereas, for ROS1-positive NSCLC, it is registered in more than 60 countries.


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