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Showing 101 - 150FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma
On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or...
FDA Grants Priority Review to sBLA for Pembrolizumab in Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking accelerated approval for pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic...
Study Examines Link Between Squamous Cell Carcinoma and Recessive Dystrophic Epidermolysis Bullosa
Many patients with the rare skin disease recessive dystrophic epidermolysis bullosa (RDEB)—commonly called butterfly syndrome—also develop squamous cell carcinoma early in life. Now an international team of scientists led by researchers at the Sidney Kimmel Cancer...
Gene-Expression Predictor for Immunotherapy Response in Melanoma
In a new study, researchers developed a gene expression predictor that can indicate whether melanoma in a specific patient is likely to respond to treatment with immune checkpoint inhibitors. Their research was published by Auslander et al in Nature Medicine. “There is a critical need to be...
Basal Cell Carcinoma and Risk for Development of Other Cancers
Patients who develop frequent cases of basal cell carcinoma appear to be at significantly increased risk for the development of other cancers, according to a study published by Cho et al in JCI Insight. Methods Researchers studied 61 people treated at Stanford Health Care for frequent...
FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids
Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Research Finds Failings in Some Apps Used for the Diagnosis of Skin Cancer
In the scramble to bring successful apps for the diagnosis of skin cancer to market, there is a concern that a lack of testing is risking public safety, according to research led by the University of Birmingham. The research, outlined at the British Association of Dermatologists Annual...
Immunosuppressants and Cutaneous Squamous Cell Carcinoma in Organ Transplant Recipients
Research published by Jung et al in OncoImmunology showed organ transplant recipients may reduce their risk of developing secondary skin cancer by changing their immunosuppressant medication. University of Queensland (UQ) researchers have studied the impact of such medications on the immune...
Two Phase III Trials of KX2-391 in Actinic Keratosis Achieve Primary Endpoints
Two phase III studies—KX-AK-003 and KX-AK-004—achieved their primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, with each study achieving statistical significance (P < .0001). Statistical significance (P < .001) ...
Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
Indocyanine Green in Sentinel Lymph Node Biopsy for Merkel Cell Carcinoma
High rates of regional lymph node involvement and metastases are not uncommon in Merkel cell carcinoma. National Comprehensive Cancer Network (NCCN) Guidelines recommend sentinel lymph node biopsy (SLNB) for staging purposes in this malignancy. In a study by Knanckstedt et al in ...
Human Papillomavirus Vaccine in Cutaneous Basaloid Squamous Cell Carcinomas
Squamous cell carcinoma is the second-most-common form of skin cancer. Evidence suggests the human papillomavirus (HPV) plays a role in the development of some types of this skin cancer. Two years ago, a 97-year-old woman whose right leg was covered with squamous cell tumors went to see...
Flight Attendants May Be at Increased Risk of Breast, Skin Cancers
Flight attendants showed an elevated incidence of several types of cancer compared with the general population, according to findings published by McNeely et al in Environmental Health. “Our findings of higher rates of several cancers among flight attendants is striking given the low rates...
FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or...
Educational Interventions Decrease Sunburns Among Operators of Heavy Equipment
The implementation of educational interventions among heavy equipment operators, or operating engineers, in Michigan significantly increased the use of sunscreen and decreased the number of sunburns, reported Duffy et al in Cancer Epidemiology, Biomarkers & Prevention. “The rates of...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
2018 ASCO: 2-Year Update of Pivotal JAVELIN Merkel 200 Trial Shows Continued Durable Responses With Avelumab
Updated efficacy and safety data from the international, multicenter JAVELIN Merkel 200 trial of avelumab (Bavencio) in patients with metastatic Merkel cell carcinoma were presented by Nghiem et al at the 2018 ASCO Annual Meeting (Abstract 9507). 2-Year Follow-up At the 2-year follow-up update of ...
Paolo A. Ascierto, MD, on Melanoma: Results From the COLUMBUS Trial
Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori–Fondazione Pascale, discusses phase III study findings on encorafenib plus binimetinib vs vemurafenib or encorafenib in BRAF-mutant melanoma (Abstract 9504).
Emily S. Ruiz, MD, MPH, on Squamous Cell Carcinoma: Expert Perspective
Emily S. Ruiz, MD, MPH, of Brigham and Women’s Cancer Center, discusses new developments in the treatment of squamous cell skin cancer and what she sees on the therapeutic horizon (Abstracts e18703, 9519, and 9577).
Danny Rischin, MD, on Squamous Cell Carcinoma: Treatment Trial Results
Danny Rischin, MD, of Peter MacCallum Cancer Centre, discusses phase II study findings on cemiplimab, a human monoclonal anti–PD-1 antibody, in patients with metastatic cutaneous squamous cell carcinoma (Abstract 9519).
FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 30, the U.S. Food and Drug Administration (FDA) accepted for priority review the biologics license application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma or patients with locally advanced cutaneous squamous cell carcinoma who...
Canadian Study Explores the Economic Burden of Workplace Sun Exposure and Nonmelanoma Skin Cancer
A study by Mofidi et al in the Journal of Occupational and Environmental Hygiene has estimated the total and per-case costs of newly diagnosed nonmelanoma skin cancers in Canada in 2011 caused by workplace sun exposure. Using a range of secondary sources, including official government records and...
Men With Nonmelanoma Skin Cancer History May Have Reduced Risk of Death From Melanoma
Skin cancer survivors know firsthand that the disease is most treatable when detected early, so they’re more likely to be vigilant about skin exams—and new research shows that such vigilance pays off. After studying more than 900 cases of melanoma reported through the Health...
FDA Approves Dabrafenib Plus Trametinib for Adjuvant Treatment of Melanoma With BRAF V600E or V600K Mutations
On April 30, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to dabrafenib (Tafinlar) and trametinib (Mekinist) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations (as detected by an FDA-approved test) and involvement of...
Link Between Risk of Alzheimer’s Disease and Melanoma, Nonmelanoma Skin Cancers
Although literature demonstrates a decreased risk of Alzheimer's disease in individuals with various cancers—including squamous cell cancers (SCC) and basal cell cancers (BCC)—there is a paucity of literature to substantiate an association between malignant melanoma and...
Follicular Extension in Actinic Keratosis and Invasion in Squamous Cell Carcinoma
Actinic keratoses may show extension down into follicles, not only in cases with full-thickness epidermal atypia (bowenoid actinic keratosis), but also in cases with atypia limited to the epidermal basalis. Previous studies have demonstrated that, in bowenoid actinic keratosis, follicular...
AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1
A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...
Epacadostat Combined With Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
On April 6, an external data monitoring committee commented on results from the phase III ECHO-301/KEYNOTE-252 trial of the investigational IDO1 inhibitor epacadostat plus pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma. The committee determined that the study did not...
Notch Signaling and Treatment With Vismodegib in Basal Cell Carcinoma
A study by Eberl et al in Cancer Cell has pinpointed a mechanism that controls how basal cell cancers respond to treatment and offers new ideas for controlling this disease. Basal cell carcinomas are incredibly common—somewhere between 1 million to 3 million diagnosed each year—and...
EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery....
AAD Issues Guidelines for Treatment of Nonmelanoma Skin Cancer
Skin cancer is the most common cancer in the United States, and nonmelanoma skin cancer is the most common type of skin cancer, affecting more than 3 million Americans every year. Moreover, nonmelanoma skin cancer incidence is growing at an exponential rate—between 1976–1984 and...
SSO 2018: Outcomes of Patients With Metastatic Melanoma Selected for Surgery After Immunotherapy
Immunotherapy has transformed the treatment of metastatic melanoma, with 3-year survival rates surpassing 50% for appropriate patients. However, many of these patients still require surgery, but very little research has been done on this group of patients to determine whether surgery after...
April K.S. Salama, MD, on Melanoma: Treating Recurrent or Progressive Distant Disease
April K.S. Salama, MD, of Duke Cancer Institute, talks about how to select systemic therapy for a patient with previously treated metastatic melanoma.
U.S. Incidence and Projected Rise of Merkel Cell Carcinoma
The number of U.S. cases of Merkel cell carcinoma is rising about six times faster than most other cancers, and at nearly twice the rate of melanoma. Paulson et al reported these findings in The Journal of the American Academy of Dermatology, which are based on research conducted at the University...
Presurgical Targeted Therapy Delays Relapse of High-Risk Stage III Melanoma
A pair of targeted therapies given before and after surgery for melanoma produced at least a sixfold increase in time to progression compared to standard-of-care surgery for patients with stage III disease, Amaria et al reported in The Lancet Oncology. Patients who had no sign of disease at surgery ...
Study Finds Desmoplastic Melanoma Highly Responsive to PD-1/PD-L1 Blockade
Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...
Growing Socioeconomic and Racial Disparities in Management of Brain Metastases
Increasing use of a potentially life-saving treatment for metastatic cancer is leaving too many vulnerable patients behind, according to a new study from Yale Cancer Center/Smilow Cancer Hospital published by Kann et al in JNCCN – Journal of the National Comprehensive Cancer Network. The...
Adjuvant Pembrolizumab Improves Recurrence-Free Survival in Stage III Resected High-Risk Melanoma
On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...
FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma
On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...
Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
Effectiveness of Sentinel Lymph Node Biopsy in Patients With Newly Diagnosed Melanoma
Research presented at the 9th World Congress of Melanoma supports the updated guideline recommendation that sentinel lymph node biopsy be performed in more patients newly diagnosed with melanoma, as it has the potential to save lives due to the information the procedure provides. This biopsy can...
Intratumoral Plasmid IL-12 With Electroporation in Stage III/IV Melanoma
OncoSec Medical Incorporated presented new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid] with electroporation) at the 9th World Congress of Melanoma. “We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse ...
Axl Inhibitor BGB324 in Combination With Trametinib Plus Dabrafenib or Pembrolizumab in Advanced Melanoma
BerGenBio ASA announced that the randomized phase Ib/II clinical study of the Axl inhibitor BGB324 in combination with either the MAP kinase inhibitors trametinib (Mekinist) plus dabrafenib (Tafinlar) or the immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with advanced melanoma is...
ESMO 2017: Combination Targeted Adjuvant Therapy Doubles Relapse-Free Survival in Stage III Melanoma
Combination targeted adjuvant therapy with dabrafenib (Tafinlar) and trametinib (Mekinist) doubles relapse-free survival in patients with stage III BRAF-mutant melanoma, according to late-breaking results from the COMBI-AD trial presented on September 11 at the European Society for Medical Oncology ...
ESMO 2017: Adjuvant Nivolumab Superior to Ipilimumab in Surgically Resected Stage III/IV Melanoma
Adjuvant nivolumab (Opdivo) is superior to standard-of-care ipilimumab (Yervoy) in patients with surgically resected stage III/IV melanoma who are at high risk of relapse, according to late-breaking results from the CheckMate 238 trial presented on September 11 at the European Society for Medical...
Jeffrey S. Weber, MD, PhD, on Melanoma: Results of the CheckMate 238 Trial
Jeffrey S. Weber, MD, PhD, of New York University’s Langone Medical Center, discusses study results on adjuvant therapy with nivolumab vs ipilimumab after complete resection of stage III/IV melanoma (Abstract LBA8).
Karl D. Lewis, MD, on Melanoma: Results From the BRIM8 Trial
Karl D. Lewis, MD, of the Anschutz Cancer Pavilion, discusses study findings on adjuvant vemurafenib in patients with completely resected BRAF V600–positive melanoma at high risk for recurrence (Abstract LBA7).
