FDA Approves Pembrolizumab for Adjuvant Treatment of Stage IIB or IIC Melanoma

The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is observation," wrote Jason Luke, MD, Director of the Cancer Immunotherapeutics Center in the Division of Hematology/Oncology at the University of Pittsb...

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FDA Approves Pembrolizumab Combination for Cervical Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express programmed death-ligand 1 (PD-L1). The FDA has also granted regular approval to single-agent pembrolizumab for patients with recurrent or metastatic cervical cancer whose tumors express PD-L1, with a combined positive score of ≥1, who experienced disease progression on or after c...

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Novel Treatments for Breast Cancer With Samira Syed, MD

Dr. Samira Syed, MD, is an Associate Professor of Internal Medicine at UT Southwestern Simmons Comprehensive Cancer Center, where she treats patients and focuses on breast cancer research. In this interview, Dr. Syed discusses recent therapeutic advances and future directions in the treatment of patients with breast cancer. This interview has been conducted in partnership with the National Breast Cancer Foundation (NBCF). Recognized as one of the leading breast cancer organizations in the w...

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FDA Approves Pembrolizumab for Advanced/Metastatic Urothelial Carcinoma

The FDA has granted regular approval to pembrolizumab (Keytruda®, Merck) for the first-line treatment of patients with locally advanced/metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy. This regular approval comes after the FDA granted pembrolizumab accelerated approval. "Programmed cell death protein 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors are active in metastatic urothelial carcinoma," wrote Thomas Powles, MD, Professor of Genitourinary ...

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Pembrolizumab Approval Withdrawn for Third-Line Gastric Cancer Treatment

Yesterday, Merck announced that it will voluntarily withdraw the accelerated approval indication of pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1 and who experienced disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and human e...

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Pembrolizumab Approved for HER2-Positive Gastric Cancer

The FDA has granted accelerated approval to pembrolizumab (Keytruda®, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2- positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. "The PD-1 (programmed cell death protein 1)/PD-L1 (programmed death-ligand 1) pathway is an important regulatory component of the immune response and plays a critica...

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Pembrolizumab for Esophageal or Gastroesophageal Junction Carcinoma: Ken Kato, MD, PhD

Recently, the FDA approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) carcinoma who do not qualify for surgical resection or definitive chemoradiation. The approval was based on the results of KEYNOTE-590, a phase 3 trial that demonstrated significant improvements in progression-free survival and overall survival for patient...

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Pembrolizumab Plus Chemotherapy Approved for Esophageal and Gastroesophageal Junction Carcinoma

The FDA has approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) carcinoma who do not qualify for surgical resection or definitive chemoradiation. "Pembrolizumab plus chemotherapy versus chemotherapy was superior for overall survival in patients with esophageal squamous cell carcinoma (ESCC) with a combined positive score (CP...

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Lenvatinib/Pembrolizumab Improves Survival in Renal Cell Carcinoma

Results from a phase 3 trial of patients with advanced renal cell carcinoma (RCC) presented this week at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium and simultaneously published in The New England Journal of Medicine demonstrated that the first-line treatment regimen of lenvatinib, a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor, plus pembrolizumab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody, lengthened ...

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Pembrolizumab FDA Approved for Triple-Negative Breast Cancer

The FDA recently approved pembrolizumab (Keytruda®, Merck & Co) with chemotherapy for patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) for those whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. In addition, the FDA approved the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.), to select patients with TNBC for pembrolizumab. Efficacy was shown in KEYNOTE-355 (NCT02819518), a multicenter, double-bl...

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Frontline Pembrolizumab for PD-L1–Positive Gastric Cancer: Kohei Shitara, MD

Gastric or gastroesophageal junction (G/GEJ) cancer constitutes the third leading cause of cancer death worldwide, and more therapeutic options are needed. In results from the phase 3 KEYNOTE-062 study, published last week in JAMA Oncology, Kohei Shitara, MD, and colleagues reported that in patients with previously untreated G/GEJ cancer with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater, pembrolizumab, alone or in combination with chemotherapy, was nonin...

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PD-L1–Positive Gastric Cancer: Frontline Pembrolizumab Noninferior to Chemotherapy

Data from the phase 3 KEYNOTE-062 trial have revealed that in patients with advanced gastric or gastroesophageal junction (G/GEJ) cancer with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or greater, first-line pembrolizumab, alone or in combination with chemotherapy, is noninferior but not superior to chemotherapy alone. In patients with a PD-L1 CPS of 10 or greater, pembrolizumab monotherapy showed a possible benefit, but one that cannot be considered definitive o...

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Advanced Melanoma: Pembrolizumab Effective Regardless of BRAF V600E/K Mutations

In patients with advanced melanoma, pembrolizumab achieves efficacy regardless of BRAF V600E/K mutation status or prior treatment with BRAF and/or MEK inhibitors, according to the results of a new pooled analysis published in JAMA Oncology. Approximately 40% of metastatic melanomas harbor a BRAF mutation, 90% of which are an activating BRAF V600E/K mutation. While targeted agents and immune checkpoint inhibitors, including pembrolizumab, have considerably improved outcomes for patients with adva...

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FDA Approves First-Line Pembrolizumab: Metastatic MSI-High/dMMR Colorectal Cancer

Patients with unresectable or metastatic colorectal cancer with high microsatellite instability (MSI) or a deficiency in mismatch repair (dMMR) now have their first frontline immunotherapy option, thanks to the FDA's approval of pembrolizumab (Keytruda®, Merck) in this population. Efficacy and safety were investigated in an open-label phase 3 trial, KEYNOTE-177 (NCT02563002), for which 307 patients with previously untreated MSI-high/dMMR metastatic colorectal cancer and an Eastern Cooperative On...

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FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...

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Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...

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Pembrolizumab for Relapsed/Refractory Classic Hodgkin Lymphoma: John Kuruvilla, MD

This past weekend in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program, John Kuruvilla, MD, presented results of the phase 3 KEYNOTE-204 trial, reporting that pembrolizumab significantly increased progression-free survival compared with brentuximab vedotin in patients with relapsed/refractory classic Hodgkin lymphoma. In this interview with i3 Health, Dr. Kuruvilla, an Associate Professor of Medicine at the University of Toronto, discusses the challenges of treatin...

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New Dosing Guidelines for Pembrolizumab FDA Approved

The FDA recently approved new dosing guidelines of 400 mg of pembrolizumab (KEYTRUDA®, Merck) to be taken every six weeks. The current recommended dose of pembrolizumab is 200 mg every three weeks. This new dosing regimen is approved across all adult indications of pembrolizumab. Pembrolizumab is FDA approved to treat several cancers including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-...

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Pembro/Pemetrexed-Platinum: How Does It Affect Patient QOL?

In patients with previously untreated, metastatic, non-squamous non-small cell lung cancer (NSCLC), pembrolizumab plus pemetrexed-platinum has proven to be an effective treatment compared with pemetrexed-platinum alone in increasing the proportion of patients who experience a complete or partial response, as shown in the KEYNOTE-189 study. Based on the results of this study, the FDA recently approved a new indication for pemetrexed in this combination for the first-line treatment ...

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Pembrolizumab for Non-Muscle Invasive Bladder Cancer With Ashish Kamat, MD, MBBS

The FDA recently approved pembrolizumab (Keytruda®, Merck) for the treatment of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to bacillus Calmette-Guérin (BCG) therapy. The approval was based on Keynote 057 (NCT02625961), a phase 2 trial in which pembrolizumab produced a complete response rate of 41% in patients with this disease. In this interview with i3 Health, Ashish Kamat, MD, MBBS, Professor of Urologic Oncology (Surgery) and Cancer Research at MD Anderson...

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