CML Treatment Dasatinib Powder Active Pharmaceutical Ingredient CAS 302962-49-8

CML Treatment Dasatinib Powder Active Pharmaceutical Ingredient CAS 302962-49-8

Introduction

Dasatinib, previously known as BMS-354825, is a cancer drug produced by Bristol-Myers Squibb and sold under the trade name Sprycel. Dasatinib is an oral Bcr-Abl tyrosine kinase inhibitor (inhibits the "Philadelphia chromosome") and Src family tyrosine kinase inhibitor approved for first line use in patients with chronic myelogenous leukemia (CML)[1] and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is being evaluated for use in numerous other cancers, including advanced prostate cancer.

Efficacy

In a Phase I dose escalation study published in June 2006, dasatinib was tested in patients who were resistant to or who could not tolerate imatinib.[2] Complete hematological responses[3] were seen in 37 of 40 patients with chronic-phase CML. Major hematologic responses were seen in 31 of 44 patients with accelerated-phase CML, CML in blast crisis, or Ph+ ALL.

Medical Uses

Oxaliplatin is used for treatment of colorectal cancer, typically along with folinic acid and 5-fluorouracil in a combination known as FOLFOX. Oxaliplatin has been compared with other platinum compounds used for advanced cancers, such as cisplatin and carboplatin.

Product Name	Dasatinib monohydrate
Appearance	White to off- white crystalline powder
Odor &Taste	Characteristic
Test Method	HPLC
Specification	98.5%min
Supplier	vanz
CAS#	863127-77-9
Molecular Formula	C22H26ClN7O2S.H2O
Molecular Weight	506.02
Structure
Packing
N.W.25kgs G.W.28kgs Paper-drums and two plastic-bags inside.
Storage
Store in cool & dry place.Keep away from strong light and heat.
Shelf life
24 months when properly stored.

Side Effects

On October 11, 2011 the U.S. Food and Drug Administration (FDA) announced that dasatinib may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary hypertension, PAH). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting dasatinib, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

Cost

The Union for Affordable Cancer Treatment objected to the price of dasatinib, in a letter to the U.S. trade representative. The average wholesale price in the U.S. is $367 per day, twice the price in other high income countries.

The price in India, where the average annual per capita income is $1,570, and where most patients pay out of pocket, is Rs6627 ($108) a day. Indian manufacturers offered to supply generic versions for $4 a day, but, under pressure from the U.S., the Indian Department of Industrial Policy and Promotion refused to issue a compulsory license