Claims for Patent: 10,328,031

Summary for Patent: 10,328,031

Title:	Methods of treating pancreatic cancer
Abstract:	Provided herein are methods for the treatment of metastatic pancreatic cancer comprising administration of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein in combination with gemcitabine.
Inventor(s):	Desai; Neil P. (Pacific Palisades, CA), Renschler; Markus (Fort Lauderdale, FL)
Assignee:	Abraxis Bioscience, LLC (Summit, NJ)
Application Number:	15/820,022
Patent Claims:	1. A method of treating pancreatic cancer in a human individual comprising administering to the individual (a) an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin; and (b) an effective amount of gemcitabine, wherein the pancreatic cancer is borderline resectable pancreatic cancer. 2. The method of claim 1, wherein the pancreatic cancer is pancreatic adenocarcinoma. 3. The method of claim 1, wherein the individual has Karnofsky performance status (KPS) of between 70 and 80. 4. The method of claim 1, wherein the individual has a high level of hENT1 (human equilibrative nucleoside transporter 1). 5. The method claim 1 wherein the composition comprising nanoparticles comprising paclitaxel and an albumin is administered intravenously. 6. The method of claim 1, wherein the dose of paclitaxel in the nanoparticle composition is about 50 mg/m.sup.2 to about 200 mg/m.sup.2. 7. The method of claim 6, wherein the dose of paclitaxel in the nanoparticle composition is about 125 mg/m.sup.2. 8. The method of claim 6, wherein the composition comprising nanoparticles comprising paclitaxel and albumin is administered weekly, three out of four weeks. 9. The method of claim 1, wherein the albumin is human serum albumin. 10. The method of claim 1, wherein the nanoparticles in the composition have an average diameter of no greater than about 200 nm. 11. The method of claim 1, wherein the weight ratio of albumin and paclitaxel in the nanoparticle composition is about 9:1 or less. 12. The method of claim 1, wherein the paclitaxel in the nanoparticles is coated with the albumin. 13. The method of claim 1, wherein gemcitabine is administered to the individual at about 500 mg/m.sup.2 to about 2000 mg/m.sup.2. 14. The method of claim 13, wherein gemcitabine is administered to the individual at about 1000 mg/m.sup.2. 15. The method of claim 13, wherein gemcitabine is administered weekly, three out of four weeks. 16. The method of 13, wherein gemcitabine is administered intravenously. 17. The method of claim 1, wherein the method is for first-line treatment.

Details for Patent 10,328,031

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		2033-01-11
Baxalta Us Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	03/03/1954		2033-01-11
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	07/23/1976		2033-01-11
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	08/15/1978		2033-01-11
Instituto Grifols, S.a.	HUMAN ALBUMIN GRIFOLS	albumin (human)	Injection	103352	02/17/1995		2033-01-11