The FDA approved the use Bksalkori (XALKORI) Pfizer's first and only product of its kind in lung cancer patients with advanced or metastatic NSCLC type ALK Positive.
Approval is the first in six years a new drug can be designed to treat lung cancer.
The Food and Drug Administration (FDA) approved the drug Ksalkori (Krizotinib), of Pfizer, to treat patients with advanced lung cancer or metastatic NSCLC that express a mutation in ALK (Anaplastic Lymphoma Kinase). The drug is removed form of capsules. This is the first drug ever approved to treat designated in this patient population.
Effectiveness of Ksalkori based on objective response rates (ORR), and since it received accelerated approval, Pfizer is now conducting additional clinical studies to evaluate additional clinical benefits of the drug.
"Every year, lung cancer causes more deaths than any other type of cancer worldwide," said Ian Reid, president and CEO of Pfizer. "Ksalkori offers advanced treatment of this deadly disease, and provides a new therapeutic option to - a group of patients the disease."
The instructions latest of the FDA regarding the treatment goal - oriented, associated diagnostic procedures unique, operated Pfizer closely with the Food and conducted the clinical trials of its collaboration with Abbott Abbot Molecular, to ensure examination at the same time and approval of both the Ksalkori and of the diagnostic kit from Abbott Vysis ALK Break Apart FISH Probe Kit, an identification of the ALK gene.
Simultaneous approval of the drug Ksalkori and diagnostic kit is a milestone, for the first time approved oncology drug from Pfizer (or any other medicine to treat lung cancer) also developed an appropriate diagnostic system.
"With a deep understanding of the structure of genes involved in the development of NSCLC, such as ALK, we are able to choose the hospital they have a better chance of responding to treatment. Ksalkori a future approach to model development and in cancer therapy drugs," says Dr. Paul Ban, Professor of Medicine and Chair James Dudley Cancer Research at the University of Colorado in Denver. "Ksalkori, she was the first drug approved to treat lung cancer by the FDA for over six years, represents a fundamental change in perception regarding the type of NSCLC cancer treatment - we're not looking for one drug fit all patients, but developers Targeted therapies appropriate patient's specific biology. "
"Ksalkori represents a new chapter in medicine Custom lung cancer patients, enabling physicians to provide every patient exactly the appropriate treatment," said Dr. Mace Rot'nberg, senior vice president clinical development and medical oncology unit of Pfizer. "Ksalkori development, from publication of the discovery of ALK gene in patients with NSCLC to drug approval by the FDA, only lasted four years - particularly fast process in oncology research, highlighting the importance of cooperation between academic research and pharmaceutical companies, diagnostic and monitoring institutions. "
* This information came from public relations' Gitam Porter Noble representing the company "Pfizer"
First preparation and unique advanced lung cancer patients or a simplified ALK Positive NSCLC
First preparation and unique advanced lung cancer patients or a simplified ALK Positive NSCLC
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