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Benefits of Crizotinib for Adult and Pediatric Cancer Patients

(Pub. 4th July, 2012)

Non-small cell lung cancer rates are rising every year. According to the American Cancer Society the rate for men in the U.S. to develop this often deadly disease is one in thirteen, and for women the risk is one in sixteen. These numbers are inclusive of non smokers and smokers combined. Crizotinib is a unique treatment for non-small cell lung cancer as it specifically targets the Anaplastic Lymphoma Kinase, or ALK gene. A diagnostic test approved by the FDA and created by Abbott Laboratories, is available for patients to determine if they have the ALK gene. Information gleaned from this test will potentially indicate a need for treatment with Crizotinib, alongside typical chemotherapy and radiation therapies. Pfizer currently holds the patent for Crizotinib, marketed as the brand name Xalkori. The patent is valid through March 1, 2025.

Approved on August 11, 2011, Crizotinib paves the way for the future of cancer therapies with targeted treatment for particular gene mutations, like the ALK gene. Bloomberg has reported a sales projection indicating that the sale of Crizotinib will produce upwards of 540 million dollars by 2015. On August 17, 2011 the European Medicines Agency accepted Pfizer’s regulatory submission for a review of Crizotinib. Clinical trials are currently offered in certain areas in the U.K., and specifically Seoul National University in Seoul, Korea and Peter MacCallum Cancer Centre, in East Melbourne, Australia. Dr. Ross Camidge of The University of Colorado has reported about these venues offering the phase one trials for Crizotinib, citing the current widespread lack of availability to be a frustrating issue for prospective participants.

Administration of Crizotinib is oral, two capsules daily, in 250 or 200 milligram strength. Crizotinib has been documented in two large multi-center studies, both of which influenced the FDA approval, to have less then 10 percent of patients drop out due to adverse effects. As a tolerable option for patients with non-small-cell lung cancer, or NSCLC, Crizotinib is essential for treating NSCLC (Non-small cell lung cancer), which represents 85 percent of the lung cancer patient population, according to formulary online.

 As an orally available small-molecule inhibitor of the ALK tyrosine kinase, Crizotinib is thought to target the "Achilles' heel" of this type of lung cancer. According to The New England Journal of Medicine and Dr. Eunice Kwak, and Oncologist at Massachusetts General Hospital, nearly 10,000 patients are helped by the administration of Crizotinib annually. Recent news has researchers looking at another exciting potential use for Crizotinib, specifically in the treatment of anaplastic large cell lymphoma and neuroblastoma in children. Anaplastic large cell lymphoma, or ALCL is a blood cancer, and neuroblastoma is a nerve cancer. Crizotinib has shown to be efficacious at treating these advanced forms of childhood cancers, and nearly all children with ALCL possess ALK gene alterations. Roughly 10-14 percent of children with neuroblastoma also harbor the ALK genetic abnormalities. Crizotinib was deemed a viable choice for treatment of these child patients, with Phase 1 trial results reported by the Children's Oncology Group, with support by the National Cancer Institute. The results, which were announced in early June 2012 at the American Society of Clinical Oncology annual meeting, were quite promising. The dose of Crizotinib administered was given without interruption in 28-day cycles. Pediatric patients were administered Crizotinib twice daily, in dose levels ranging from 100 to 365 milligrams. Of the eight patients with ALCL enrolled, a remarkable seven of these children showed a complete disappearance of their tumor. Regarding the twenty seven patients with neuroblastoma, three had complete responses, and two of those three had documented ALK gene mutations. Seven additional patients maintained health and had no disease progression, with several remaining on Crizotinib for more then two years without progression. Another seven patients with inflammatory myofibroblastic tumor, a rare tumor with ALK gene mutations, remain on therapy and continue to show benefits of their treatment with Crizotinib. These encouraging results have paved the way for future studies to determine the efficacy of treatment with Crizotinib and chemotherapeutic agents not only in children, but also in adolescents and adults. Crizotinib is poised to become a widely used therapy to target a variety of cancer types in patients with ALK mutations.

YES Pharma is proud to be a leading supply source for Crizotinib API to several global pharmaceutical companies and academic research institutes, while recognizing that we play a significant part in promoting the struggle against cancer. The Crizotinib that YES Pharma supplies is intended for laboratory R&D use only.

References:
American Cancer Society 2/17/12
Bloomberg Business 8/28/11
EMA 8/17/11
Dr. Ross Camidge, via Cancer Grace 2/13/11
Formulary-11/1/2011 for adverse effcts trial stats
New England Journal of Medicine  10/28/10
A Children's Oncology Group Phase I consortium study. Presented 5/16/2012
Patent Info.-FDA Guide Updated 3/12

  • Products covered by valid patents are not offered or supplied for commercial use.
  • Products currently covered by valid US patents are offered only for laboratory R&D use in accordance with 35 USC 271(e)+A13(1).
  • Any patent infringement and resulting liability is solely at buyer risk.

 

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