Keytruda® (pembrolizumab)

BL 125514

Keytruda® (pembrolizumab)

BL 125514

U.S. License Holder:

Merck Sharp Dohme

Date of License:

September-04-2014

Last Update:

June-09-2019

approved_indications FDA-Approved Indications

KEYTRUDA (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody indicated in:

Melanoma: for the treatment of patients with unresectable or metastatic melanoma; or the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection;

Non-Small Cell Lung Cancer (NSCLC): In combination with pemetrexed and platinum chemotherapy, as first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations; in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, as first-line treatment of patients with metastatic squamous NSCLC; as a single agent for the first-line treatment of patients with stage III NSCLC, who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [(Tumor Proportion Score (TPS) greater than or equal to 1 percent)] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 1 percent) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda;

Head and Neck Squamous Cell Cancer (HNSCC): for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy;

Classical Hodgkin Lymphoma (cHL): for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy;

Primary Mediastinal Large B-Cell Lymphoma (PMBCL): for the treatment of adult and pediatric patients with refractory PMBCL, or who have relapsed after 2 or more prior lines of therapy;

Urothelial Carcinoma: for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [Combined Positive Score (CPS) greater than or equal to 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status; for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant treatment with platinum-containing chemotherapy;

Microsatellite Instability-High Cancer: for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan;

Gastric Cancer: for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score (CPS) greater than or equal to 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy;

Cervical Cancer: for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS greater than or equal to 1) as determined by an FDA-approved test;

Hepatocellular Carcinoma (HCC): For the treatment of patients with HCC who have been previously treated with sorafenib;

Merkel Cell Carcinoma (MCC): For the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma;

Renal Cell Carcinoma (RCC): In combination with axitinib, for the first-line treatment of patients with advanced RCC.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2016-01217

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled Prior to Institution Decision

IPR Status
Settled Prior to Institution Decision

IPR2016-01218

U.S. Patent No.
9,067,999 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled Prior to Institution Decision

IPR Status
Settled Prior to Institution Decision

IPR2016-01219

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled Prior to Institution Decision

IPR Status
Settled Prior to Institution Decision

IPR2016-01221

U.S. Patent No.
9,073,994 (Immunopotentiative Composition)

Patent Owner
Bristol-Myers Squibb Co.; ER Squibb and Sons, LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Petitioner(s)
Merck Sharp and Dohme Corp.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Settled Prior to Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Settled Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y- Settled Prior to Institution Decision

IPR Status
Settled Prior to Institution Decision

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:14-cv-01131 (D. Del.)

U.S. Patent Nos.
8,728,474 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00560 (D. Del.)

U.S. Patent Nos.
9,067,999 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:15-cv-00572 (D. Del.)

U.S. Patent Nos.
9,073,994 (Immunopotentiative Composition)

Plaintiffs
Bristol-Myers Squibb Co.; E.R. Squibb and Sons LLC; Ono Pharmaceutical Co., Ltd.; Tasuku Honjo

Defendants
Merck and Co., Inc.; Merck Sharp and Dohme Corp.

Status
Settled

BPCIA
N

1:16-cv-00407 (D.N.J.)

U.S. Patent Nos.
5,693,761 (Polynucleotides Encoding Improved Humanized Immunoglobulins)

Plaintiffs
PDL Biopharma, Inc.

Defendants
Merck Sharpe & Dohme Corp.

Status
Settled

BPCIA
N

3:15-cv-00536 (D. Nev.)

U.S. Patent Nos.
5,693,761 (Polynucleotides Encoding Improved Humanized Immunoglobulins)

Plaintiffs
PDL Biopharma, Inc.

Defendants
Merck Sharpe & Dohme Corp.

Status
Case Voluntarily Dismissed

BPCIA
N

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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