The FDA has granted accelerated approval to retifanlimab-dlwr (Zynyz™, Incyte), a programmed cell death protein 1 (PD-1)–blocking antibody, for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). "Retifanlimab is a humanized, hinge-stabilized immunoglobulin G4 kappa (IgG4κ) anti–PD-1 monoclonal antibody with safety and clinical pharmacology that are characteristic for the class," wrote Giovanni Grignani, MD, a Medical Oncologist at the Candiolo Cancer Instit...

The FDA has approved the combination of nivolumab and relatlimab-rmbw (Opdualag™, Bristol-Myers Squibb) for patients with unresectable or metastatic melanoma. OpdualagTM is a fixed-dose dual immunotherapy combination of nivolumab, a programmed cell death protein 1 (PD-1)–blocking antibody, and relatlimab, a first-in-class human lymphocyte–activation gene 3 (LAG-3)–blocking antibody, and is administered as a single intravenous (IV) infusion. "LAG-3 and PD-1 are distinct inhibitory immune checkpoi...

Recently, the FDA approved the combination of relatlimab plus nivolumab for patients with unresectable or metastatic melanoma. However, many challenges remain in the selection of patients who will benefit from these agents and in determining alternative options for those who are ineligible for the combination. In this interview in honor of Melanoma Awareness Month, Dr. Benjamin Izar discusses the risk-benefit balance of immunotherapy selection and offers advice for clinicians in how to choose th...

Despite the many obstacles associated with treating and managing patients with metastatic colorectal cancer, the ongoing study of several novel agents has the potential to significantly improve the outcomes of these patients in the coming years. In this interview, Tanios Bekaii-Saab, MD, Professor of Medicine at the Mayo Clinic Cancer Center in Phoenix, Arizona, discusses strategies to optimize the management of metastatic colorectal cancer and the promising developments which may advance treatm...

Thyroid cancer is one of the most prevalent cancers in the United States. An estimated 56,870 new cases are diagnosed annually, and 2,010 people die of the disease. Thyroid cancer is typically more aggressive in men than women and becomes increasingly lethal in those older than age 40. The dearth of data from well-designed trials has led to confusion over the optimal management strategies for individual patients. In this interview, Jochen Lorch, MD, MS, Assistant Professor of Medicine at Harvard...

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...

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...

· Keira Smith: Welcome to Oncology Data AdvisorTM, where we explore the latest advances in cancer research and treatment. I'm Keira Smith. In this podcast, Dr. Sara Tolaney from Dana-Farber Cancer Institute will be discussing strategies for improving the management of patients with metastatic breast cancer. Thank you for joining us, Dr. Tolaney. Sara Tolaney, MD, MPH: Thanks so much for having me. I'm Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute here in Bo...

The survival rate for lung cancer has improved significantly in recent years, largely due to the adoption of biomarker testing and the development of targeted therapies. In this interview in honor of Lung Cancer Awareness Month, Beth Sandy, MSN, CRNP, Outpatient Thoracic Oncology Nurse Practitioner at the University of Pennsylvania Abramson Cancer Center, discusses the importance of utilizing biomarker testing in order to determine treatment options for patients with lung cancer. Oncology Data A...

In consultation with the FDA, the accelerated approval of atezolizumab (Tecentriq®, Genentech) in combination with nab-paclitaxel has been voluntarily withdrawn from the treatment of patients with programmed death ligand 1 (PD-L1)–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). "Triple-negative breast cancer is a heterogenous disease entity with a high unmet medical need," wrote David Miles, MD, Lead Clinician for Breast Cancer at Mount Vernon Cancer Ce...

Keira Smith: Hi, I'm Keira Smith from Oncology Data AdvisorTM. I'm here today with Dr. Sara Tolaney. Sara Tolaney, MD, MPH: Thanks so much for having me. I'm Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute here in Boston. Keira Smith: Thank you so much for joining us, Dr. Tolaney. So what are some of the most challenging aspects of managing patients with metastatic breast cancer? Dr. Tolaney: I think we've made incredible progress for our patients with metastatic br...

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) for patients with high-risk early-stage triple-negative breast cancer (TNBC) as neoadjuvant treatment in combination with chemotherapy and as single-agent adjuvant treatment following surgery. In addition, the FDA has confirmed the November 2020 accelerated approval of pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC with a programmed death ligand 1 (PD-L1) combined ...

Merkel cell carcinoma is a skin cancer where the Merkel cells grow out of control. In this excerpt of the transcript from their continuing medical education/nursing continuing professional development (CME/NCPD)–approved activity, Update on Immunotherapeutic Strategies for Advanced Merkel Cell Carcinoma, Shailender Bhatia, MD, Associate Professor at the University of Washington School of Medicine, and Ciara Kelly, MBBCh, BAO, Assistant Attending Physician at Memorial Sloan Kettering Cancer Cente...

The FDA has granted approval to nivolumab (Opdivo®, Bristol Myers Squibb) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy. "No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer," wrote the investigators of the phase 3 CheckMate 577 trial...

The FDA has granted accelerated approval to dostarlimab-gxly (Jemperli®, GlaxoSmithKline) for patients with mismatch repair deficient recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing chemotherapy. "The prognosis for patients with a diagnosis of advanced or recurrent endometrial cancer is poor, and, to our knowledge, there are no accepted consensus-based guidelines for standard of care after the disease progresses while undergoing or after treat...

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...

Recently, the FDA granted approval to cemiplimab (Libtayo®, Regeneron Pharmaceuticals) for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or who are ineligible for HHI therapy. In this interview, Karl Lewis, MD, Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus and one of the investigators of Study 1620 (NCT03132636), on which the approval was based, spe...

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...

PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen...