FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic... (dy received SPRYCEL 70 mg twice daily as...)

FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML

Date:11/8/2007

dy received SPRYCEL 70 mg twice daily as described earlier. Per the new labeling, the recommended starting dose for these patients with chronic-phase CML is now 100 mg once daily.

Cytogenetic and Hematologic Responses

Major cytogenetic response is defined as complete (0 percent of Philadelphia chromosome-positive [Ph+] cells in the bone marrow) plus partial (less than or equal to 35 percent of Ph+ cells in the bone marrow) cytogenetic responses. Complete hematologic response is a measure of how effective a treatment is in returning blood counts to normal and occurs when blood counts appear normal and patients have no signs or symptoms of disease.

About SPRYCEL

On June 28, 2006, the U.S. Food and Drug Administration (FDA) granted accelerated approval of SPRYCEL (pronounced 'spris-el), an oral inhibitor of multiple tyrosine kinases, for the treatment of adults in all three phases of CML (chronic-, accelerated-, or myeloid or lymphoid blast-phase) with resistance or intolerance to prior therapy including Gleevec. The effectiveness of SPRYCEL is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. The FDA also granted full approval of SPRYCEL for the treatment of adults with Ph+ ALL with resistance or intolerance to prior therapy.

Resistance to Gleevec is often due to mutations of BCR-ABL, BCR-ABL over- expression, or activation of new pathways. SPRYCEL is the first approved oral multiple tyrosine kinase inhibitor that, at nanomolar concentrations, inhibits BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRBeta kinases. SPRYCEL is designed to inhibit the overproduction of leukemia cells in the bone marrow of patients with CML and Ph+ ALL and allows normal red cell, white cell, and blood platelet production to resume.

IMPORTANT SAFETY INFORMATION

Myelosuppression:

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FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic...(dy received SPRYCEL 70 mg twice daily as...)