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Pembrolizumab Plus Chemoradiotherapy Approved for FIGO 2014 Stage III-IVA Cervical Cancer

The FDA has granted approval for pembrolizumab (Keytruda®, Merck) with chemoradiotherapy (CRT) for patients with International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage III-IVA cervical cancer. For background: "Pembrolizumab has shown efficacy in patients with cervical cancer," said Domenica Lorusso, MD, PhD, an Associate Professor of Obstetrics and Gynecology at the Catholic University of Rome, and colleagues, in their updated results of the KEYNOTE-A18 trial (NCT04221945), on w...

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Enfortumab Vedotin-ejfv Plus Pembrolizumab Approved for Urothelial Cancer

The FDA has approved enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) in combination with pembrolizumab (Keytruda®, Merck) for patients with locally advanced or metastatic urothelial cancer (UC). The FDA previously granted accelerated approval for this therapy combination for patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy.   Why it matters: "Cisplatin-based combination chemotherapy remains the standard of care for locally advanced ...

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Enfortumab Vedotin Plus Pembrolizumab Approved For Urothelial Carcinoma

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monotherapy treatments in patients with locally advanced or metastatic urothelial carcinoma," began Christopher Hoimes, Associate Professor of Medicine at t...

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Revision of Pembrolizumab Indication for Gastric Cancer

The FDA has amended the existing indication of pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. While this indication remains approved under the accelerated approval regulations, this revision restricts its use to patients whose tumors e...

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Pembrolizumab Approved for Biliary Tract Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) in combination with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC).   Why it matters: "Biliary tract cancers, which arise from the intrahepatic or extrahepatic bile ducts and the gallbladder, generally have a poor prognosis and are rising in incidence worldwide," wrote Robin Kate Kelley, MD, a Gastrointestinal Oncologist at The University of California, San Francisco, and colleagues, ...

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Enfortumab Vedotin Plus Pembrolizumab: Results of the EV-302 Trial With Thomas Powles, MD, MBBS, MRCP

Oncology Data Advisor® · Enfortumab Vedotin Plus Pembrolizumab: Results of the EV-302 Trial With Thomas Powles In this interview, Thomas Powles, MD, MBBS, MRCP, Director of the Barts Cancer Center in London, sat down with Oncology Data Advisor to discuss the results of the EV-302 trial, a phase 3, open-label investigation of enfortumab vedotin plus pembrolizumab for previously untreated locally advanced or metastatic urothelial cancer.   Oncology Data Advisor: Welcome to Oncology...

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Pembrolizumab Approved for Neoadjuvant/Adjuvant Treatment of Non–Small Cell Lung Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for non–small cell lung cancer (NSCLC) as neoadjuvant treatment in combination with platinum-containing chemotherapy, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable tumors, defined as those with a tumor ≥4 cm or node-positive.   Why it matters: "In patients with NSCLC, pembrolizumab has shown efficacy as monotherapy in the adjuvant and advanced settings and in combination with chemo...

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Enfortumab Vedotin Plus Pembrolizumab: Results of the EV-302 Trial With Thomas Powles, MD, MBBS, MRCP

In this interview, Thomas Powles, MD, MBBS, MRCP, Director of the Barts Cancer Center in London, sat down with Oncology Data Advisor to discuss the results of the EV-302 trial, a phase 3, open-label investigation of enfortumab vedotin plus pembrolizumab for previously untreated locally advanced or metastatic urothelial cancer.   Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, I have the honor of being joined by Dr. Thomas Powles to discuss the results of the EV-302 trial. Dr...

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Pembrolizumab Approved for Adjuvant Treatment of Non–Small Cell Lung Cancer

The FDA has approved pembrolizumab (Keytruda®, Merck) for adjuvant treatment of stage IB, II, or IIIA non–small cell lung cancer (NSCLC), following resection and platinum-based chemotherapy. "Although adjuvant chemotherapy improves overall survival in completely resected NSCLC, the absolute 5-year survival benefit is moderate compared with observation alone," wrote Mary O'Brien, MD, Head of Royal Marsden Hospital's Lung Unit, and colleagues, in their published results of the KEYNOTE-091 trial (N...

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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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Exploring the Impact of Cemiplimab and Pembrolizumab in Cutaneous Squamous Cell Carcinoma With Shaheer Khan, DO

Recently, Oncology Data Advisor spoke with Dr. Shaheer Khan, an Assistant Professor of Medicine at Columbia University Irving Medical Center, in honor of Skin Cancer Awareness Month. Dr. Khan shares the promising results of two recent trials of cemiplimab and pembrolizumab for cutaneous squamous cell carcinoma, explains future directions in the treatment of patients who are ineligible for immunotherapy, and offers advice for members of the multidisciplinary cancer care team who are treating patients with this disease.  

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Pembrolizumab Approved for Treatment of Advanced Endometrial Carcinoma

The FDA has approved pembrolizumab (Keytruda®, Merck) as a monotherapy for patients with advanced endometrial carcinoma that is microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression subsequent to systemic therapy and are not eligible for curative therapy or radiation. In addition, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems, Roche Tissue Diagnostics) to be used as a companion diagnostic device for selecting eligible...

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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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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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