Kyprolis

Treats relapsed or refractory multiple myeloma. NDA 202714, held by Onyx Pharms Amgen. Carfilzomib.

As of Nov 14, 2026, NDA 202714 (Kyprolis), held by Onyx Pharms Amgen, was first approved by FDA on Jul 20, 2012, with 27 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2012
Review: Standard
Supplements approved: 27
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with Lenalidomide and dexamethasone; or Dexamethasone; or Daratumumab and dexamethasone; or Daratumumab and hyaluronidase-fihj and dexamethasone; or Isatuximab and dexamethasone. ( 1, 14 ) as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. ( 1, 14 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below


May 22, 2025	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 30, 2022	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 28, 2018	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Jun 7, 2018	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 17, 2018	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 21, 2016	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 24, 2015	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 20, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Products

3 strengths and forms


Kyprolis60MG/VIAL · powder;intravenous	Carfilzomib	RxReference drug
Kyprolis30MG/VIAL · powder;intravenous	Carfilzomib	RxReference drug
Kyprolis10MG/VIAL · powder;intravenous	Carfilzomib	RxReference drug

All 28 submissions, including labeling and manufacturing supplements


May 22, 2025	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 30, 2022	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 30, 2021	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 9, 2021	Supplement 32Labeling · Standard review	Approved	Label Letter
Aug 20, 2020	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 7, 2020	Supplement 29Labeling · Standard review	Approved	Letter Label
Oct 4, 2019	Supplement 27Labeling · Standard review	Approved	Letter Label
Feb 28, 2019	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 28, 2018	Supplement 21Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Jun 7, 2018	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 17, 2018	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 25, 2017	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 21, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 17, 2016	Supplement 15Labeling · Standard review	Approved	Label Letter
Aug 4, 2016	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 3, 2016	Supplement 12Labeling · Standard review	Approved	Letter Label
May 23, 2016	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 21, 2016	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 24, 2015	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Apr 24, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 21, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 27, 2015	Supplement 8Labeling · Standard review	Approved	Label Letter
Nov 3, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 2, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 31, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 21, 2013	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 20, 2012	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202714
Drugs@FDA: Overview at FDA
Company: Onyx Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters