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The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis. If you are interested in helping the Publications Committee with creating a Pharmacist's Application to Practice, please contact Jeff Price at jprice@hoparx.org.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.

March 11, 2016

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf

On March 11, 2016, the U. S. Food and Drug Administration approved crizotinib capsules (Xalkori®, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive.

The current approval was based on a multicenter, single-arm trial in patients with metastatic ROS1 rearrangement-positive NSCLC. All patients received crizotinib 250 mg orally twice daily. The efficacy outcome measures were objective response rate (ORR) according to RECIST v1.0 as evaluated by an independent radiology review (IRR) and as evaluated by the investigators. Duration of response (DoR) was an additional outcome measure.

The trial enrolled 50 patients with an age range of 25-77 years whose tumors were prospectively determined to be ROS1-positive by fluorescence in situ hybridization (FISH; 96%) or reverse transcription polymerase chain reaction (RT-PCR; 4%) clinical trial assays. The ORR by IRR was 66% (95% CI: 51%, 79%) with a median DoR of 18 months. The ORR according to investigators was 72% (95% CI: 58%, 84%).

The safety results of this trial were generally consistent with the safety profile of crizotinib evaluated in 1,669 patients with ALK-positive metastatic NSCLC. The most common adverse reactions of Xalkori are vision disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory infection, dizziness, and neuropathy.

The recommended dose and schedule for crizotinib is 250 mg capsules taken by mouth twice daily.

This application was approved before the Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2016. Crizotinib received Breakthrough Therapy Designation for the ROS1-positive development program and the application was granted Priority Review. A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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