Claims for Patent: 9,149,455

Summary for Patent: 9,149,455

Title:	Methods of treating melanoma
Abstract:	Provided herein are methods for the treatment of melanoma comprising administration of a composition comprising nanoparticles comprising taxane and a carrier protein.
Inventor(s):	Desai; Neil P. (Los Angeles, CA), Renschler; Markus (San Francisco, CA)
Assignee:	ABRAXIS BIOSCIENCE, LLC (Los Angeles, CA)
Application Number:	13/791,841
Patent Claims:	1. A method of treating melanoma in a human individual comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin, wherein the individual is selected for treatment based on the individual having a melanoma comprising a V600E mutation in BRAF and wherein the composition is administered intravenously and the dose of paclitaxel in the composition is about 80 mg/m.sup.2 to about 200 mg/m.sup.2. 2. The method of claim 1, wherein the individual is selected for treatment based on the individual having metastatic melanoma at stage M1c. 3. The method of claim 1, wherein the individual is selected for treatment based on the individual having a serum LDH level of between about 1.1.times. to about 2.0.times.ULN. 4. The method of claim 1, wherein the method further comprises a second therapy. 5. The method of claim 4, wherein the method comprises administration of at least one other therapeutic agent. 6. The method of claim 5, wherein the other therapeutic agent is a BRAF inhibitor. 7. The method of claim 5, wherein the other therapeutic agent is Ipilimumab. 8. The method of claim 1, wherein the method is used as a first line therapy. 9. The method of claim 1, wherein the method is used as a second line therapy. 10. The method of claim 1, wherein the dose of paclitaxel in the nanoparticle composition is about 150 mg/m.sup.2. 11. The method of claim 1, wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered weekly. 12. The method of claim 11, wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered on days 1, 8, and 15 of a 28-day treatment cycle. 13. The method of claim 1, wherein the albumin is human serum albumin. 14. The method of claim 1, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm. 15. The method of claim 1, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less. 16. The method of claim 1, wherein the paclitaxel in the nanoparticles are coated with the albumin.

Details for Patent 9,149,455

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10/21/1942		2032-11-09
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2032-11-09
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2032-11-09
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2032-11-09
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2032-11-09
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	06/11/2003		2032-11-09