Posted from: Tuesday, September 05, 2017 - 04:03 PM - Present

Vyxeos Approved for Acute Myeloid Leukemia

August 3, 2017 – The U.S. FDA has approved Vyxeos™ (daunorubicin/cytarabine), manufactured by Jazz Pharmaceuticals. Vyxeos is indicated for the treatment of adults who have newly diagnosed therapy-related acute myeloid leukemia (t-AML), or who have AML with myelodysplasia-related changes (AML-MRC). The drug will be available in single-use vials that contain 44mg of daunorubicin and 100mg cytarabine encapsulated in liposomes as lyophilized powder cake. It must be reconstituted for administration, and delivered via intravenous injection.

The American Cancer society reports that approximately 21,000 patients are diagnosed with AML each year in the U.S. The majority of these patients are adults over the age of 45. The disease begins in immature bone marrow cells, which are more prone to mutation in older individuals. As a result, AML can be more aggressive in older patients, who may find standard treatments too strong to tolerate.

In a clinical study that included 309 patients between 60 and 75 years of age, the average overall survival rate for those receiving Vyxeos was longer (9.6 months) than for those who received daunorubicin and cytarabine as separate agents (5.9 months). Patients treated with Vyxeos typically had a better response rate than those who were not, and a higher rate of improving sufficiently to undergo stem cell transplants.

Vyxeos has a recommended doing of 44mg daunorubicin/100mg cytarabine per square meter (m2) of body surface area (BSA) for induction therapy. This dosage is administered on days 1, 3, and 5 of the first week of Vyxeos treatment. Patients who do not respond can receive a second induction using the same dosage after two to five weeks, given on the first and third days only. Once patients respond, consolidation cycles are administered on the first and third days once every two to five weeks at 29mg daunorubicin/65mg cytarabine per m2.

Vyxeos has already been launched.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Thursday, September 21, 2017 - 02:51 AM.