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FDA Alerts
Subcutaneous Amivantamab Receives FDA Priority Review for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
07/30/2026
Emily Estrada
The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.
The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.
The FDA granted Priority Review...
07/30/2026
Oncology
News
Alpha DaRT® Plus Pembrolizumab Achieves 100% Response Rate in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
07/21/2026
Stephanie Holland
Results from a prospective study demonstrated that Alpha DaRT® combined with pembrolizumab achieved a 100% systemic objective response rate among evaluable patients with recurrent unresectable or metastatic head and neck squamous cell...
Results from a prospective study demonstrated that Alpha DaRT® combined with pembrolizumab achieved a 100% systemic objective response rate among evaluable patients with recurrent unresectable or metastatic head and neck squamous cell...
Results from a prospective study...
07/21/2026
Oncology
News
Metronomic Chemo-Immunotherapy Improves Survival in Metastatic Head and Neck Cancer
05/31/2026
Stephanie Holland
Results from a phase 3 trial showed that triple oral metronomic chemotherapy combined with ultra-low-dose nivolumab demonstrates clinical promise among patients with recurrent or metastatic head and neck squamous cell carcinoma.
Results from a phase 3 trial showed that triple oral metronomic chemotherapy combined with ultra-low-dose nivolumab demonstrates clinical promise among patients with recurrent or metastatic head and neck squamous cell carcinoma.
Results from a phase 3 trial...
05/31/2026
Oncology
News
Adding Sintilimab to Adjuvant Capecitabine Fails to Improve PFS in High-Risk Nasopharyngeal Carcinoma
05/31/2026
Stephanie Holland
Results from a randomized phase 2 trial demonstrated that adding sintilimab to adjuvant capecitabine did not significantly improve PFS in patients with locoregionally advanced nasopharyngeal carcinoma who experienced a suboptimal response to...
Results from a randomized phase 2 trial demonstrated that adding sintilimab to adjuvant capecitabine did not significantly improve PFS in patients with locoregionally advanced nasopharyngeal carcinoma who experienced a suboptimal response to...
Results from a randomized phase...
05/31/2026
Oncology
News
Sequential Chemoradiotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
08/19/2025
Stephanie Holland
According to results from a phase 3 trial, sequential chemoradiotherapy plus concurrent chemoradiotherapy was noninferior compared to induction chemoradiotherapy plus concurrent chemoradiotherapy among newly diagnosed patients with...
According to results from a phase 3 trial, sequential chemoradiotherapy plus concurrent chemoradiotherapy was noninferior compared to induction chemoradiotherapy plus concurrent chemoradiotherapy among newly diagnosed patients with...
According to results from a...
08/19/2025
Oncology
Danny Rischin, MD, Peter MacCallum Cancer Centre
Videos
Adjuvant Cemiplimab as New Standard of Care for Patients With High-Risk Cutaneous Squamous Cell Carcinoma
06/06/2025
Danny Rischin, MD
Danny Rischin, MD, discusses the results from the phase 3 C-POST trial evaluating adjuvant cemiplimab for patients with high-risk cutaneous squamous cell carcinoma.
Danny Rischin, MD, discusses the results from the phase 3 C-POST trial evaluating adjuvant cemiplimab for patients with high-risk cutaneous squamous cell carcinoma.
Danny Rischin, MD, discusses the...
06/06/2025
Oncology
Conference Coverage
Adjuvant Nivolumab Plus Chemoradiotherapy Decreases Chance of Recurrence in Patients With Head and Neck Cancer
06/01/2025
Emily Estrada
The addition of nivolumab to cisplatin-based chemoradiotherapy after surgery improved disease-free survival for patients with locoregionally advanced squamous cell carcinoma of the head and neck, according to findings from the NIVOPOSTOP...
The addition of nivolumab to cisplatin-based chemoradiotherapy after surgery improved disease-free survival for patients with locoregionally advanced squamous cell carcinoma of the head and neck, according to findings from the NIVOPOSTOP...
The addition of nivolumab to...
06/01/2025
Oncology
Conference Coverage
Adjuvant Nivolumab Plus Chemoradiotherapy Decreases Chance of Recurrence in Patients With Head and Neck Cancer
06/01/2025
Emily Estrada
The addition of nivolumab to cisplatin-based chemoradiotherapy after surgery improved disease-free survival for patients with locoregionally advanced squamous cell carcinoma of the head and neck, according to findings from the NIVOPOSTOP...
The addition of nivolumab to cisplatin-based chemoradiotherapy after surgery improved disease-free survival for patients with locoregionally advanced squamous cell carcinoma of the head and neck, according to findings from the NIVOPOSTOP...
The addition of nivolumab to...
06/01/2025
Oncology
News
Neoadjuvant Nivolumab Plus Chemotherapy and Chemoradiation for Patients With HPV-Negative Locally Advanced Head and Neck Squamous Cell Carcinoma
05/27/2025
Stephanie Holland
According to results from the phase 2 DEPEND trial, neoadjuvant nivolumab plus chemotherapy and response-stratified de-escalated chemoradiation demonstrated promise among patients with HPV-negative locally advanced head and neck squamous cell...
According to results from the phase 2 DEPEND trial, neoadjuvant nivolumab plus chemotherapy and response-stratified de-escalated chemoradiation demonstrated promise among patients with HPV-negative locally advanced head and neck squamous cell...
According to results from the...
05/27/2025
Oncology
News
First-Line Pembrolizumab With or Without Chemotherapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
04/08/2025
Stephanie Holland
According to long-term follow up results from the phase 3 KEYNOTE-048 study, first-line pembrolizumab with or without chemotherapy demonstrated long-term survival benefit among patients with recurrent or metastatic head and neck squamous cell...
According to long-term follow up results from the phase 3 KEYNOTE-048 study, first-line pembrolizumab with or without chemotherapy demonstrated long-term survival benefit among patients with recurrent or metastatic head and neck squamous cell...
According to long-term follow up...
04/08/2025
Oncology

Recent News

News
IO102-IO103 Plus Nivolumab and Relatlimab Demonstrates Encouraging Activity in Unresectable Melanoma
08/05/2026
Stephanie Holland
A phase 2 trial demonstrated that the investigational cancer vaccine IO102-IO103 combined with nivolumab and relatlimab achieved a 60% objective response rate in previously untreated unresectable melanoma, supporting further evaluation of the...
A phase 2 trial demonstrated that the investigational cancer vaccine IO102-IO103 combined with nivolumab and relatlimab achieved a 60% objective response rate in previously untreated unresectable melanoma, supporting further evaluation of the...
A phase 2 trial demonstrated...
08/05/2026
Oncology
News
HBI-8000 Plus Nivolumab Significantly Improves Progression-Free Survival in Advanced Melanoma
08/05/2026
Stephanie Holland
Topline results from a global phase 3 trial demonstrated that HBI-8000 plus nivolumab significantly improved progression-free survival compared with nivolumab alone in patients with advanced melanoma, supporting the combination as a potential...
Topline results from a global phase 3 trial demonstrated that HBI-8000 plus nivolumab significantly improved progression-free survival compared with nivolumab alone in patients with advanced melanoma, supporting the combination as a potential...
Topline results from a global...
08/05/2026
Oncology
FDA Approval
FDA Approves Rituximab Biosimilar for the Treatment of B-Cell Malignancies and Autoimmune Diseases
08/04/2026
Stephanie Holland
The FDA has approved a rituximab biosimilar referencing Rituxan for multiple hematologic malignancies and autoimmune diseases. Approval was supported by a comprehensive biosimilar development program demonstrating high similarity and no...
The FDA has approved a rituximab biosimilar referencing Rituxan for multiple hematologic malignancies and autoimmune diseases. Approval was supported by a comprehensive biosimilar development program demonstrating high similarity and no...
The FDA has approved a rituximab...
08/04/2026
Oncology
FDA Alerts
FDA Advisory Committee Backs RP1 Plus Nivolumab for Advanced Melanoma in 10-3 Vote
07/31/2026
Stephanie Holland
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy findings from the phase 2 IGNYTE trial of RP1 (vusolimogene oderparepvec) plus nivolumab are clinically meaningful, supporting the investigational...
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy findings from the phase 2 IGNYTE trial of RP1 (vusolimogene oderparepvec) plus nivolumab are clinically meaningful, supporting the investigational...
The FDA's Cellular, Tissue, and...
07/31/2026
Oncology
FDA Alerts
Subcutaneous Amivantamab Receives FDA Priority Review for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
07/30/2026
Emily Estrada
The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.
The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.
The FDA granted Priority Review...
07/30/2026
Oncology
News
Regorafenib Producess High Response and Durable Disease Control in KIT-Mutant Advanced Melanoma
07/29/2026
Stephanie Holland
The phase 2 RegoMel trial demonstrated that continuous daily regorafenib produced clinically meaningful antitumor activity in heavily pretreated advanced melanoma, with particularly high response rates in KIT-mutant disease and encouraging...
The phase 2 RegoMel trial demonstrated that continuous daily regorafenib produced clinically meaningful antitumor activity in heavily pretreated advanced melanoma, with particularly high response rates in KIT-mutant disease and encouraging...
The phase 2 RegoMel trial...
07/29/2026
Oncology
News
Ceralasertib Plus Durvalumab Demonstrates Limited Activity in PD-L1-Resistant Advanced Melanoma
07/29/2026
Stephanie Holland
The phase 2 MONETTE trial found that ceralasertib, administered alone or in combination with durvalumab, produced low response rates in patients with anti–PD-L1-resistant advanced melanoma, while exploratory analyses identified higher...
The phase 2 MONETTE trial found that ceralasertib, administered alone or in combination with durvalumab, produced low response rates in patients with anti–PD-L1-resistant advanced melanoma, while exploratory analyses identified higher...
The phase 2 MONETTE trial found...
07/29/2026
Oncology
News
Real-World Study Demonstrates Rapid Pain Relief, Durable Disease Control, and Manageable Safety With Nirogacestat in Young Adults With Desmoid Tumors
07/28/2026
Emily Estrada
A real-world study found that nirogacestat provided rapid pain relief, durable disease control, and a manageable safety profile in young adults with desmoid tumors, supporting its use in routine clinical practice while emphasizing the...
A real-world study found that nirogacestat provided rapid pain relief, durable disease control, and a manageable safety profile in young adults with desmoid tumors, supporting its use in routine clinical practice while emphasizing the...
A real-world study found that...
07/28/2026
Oncology
News
Real-World Study Highlights Evolving Treatment Patterns and Petsistent Diagnostic Challenges in Patients With Desmoid Tumors
07/28/2026
Emily Estrada
Real-world findings demonstrated declining use of surgery and increasing adoption of systemic therapies for desmoid tumors, while highlighting substantial symptom burden, frequent treatment changes, and increased healthcare resource...
Real-world findings demonstrated declining use of surgery and increasing adoption of systemic therapies for desmoid tumors, while highlighting substantial symptom burden, frequent treatment changes, and increased healthcare resource...
Real-world findings demonstrated...
07/28/2026
Oncology
News
Real-World Analysis Identifies Performance Status as a Key Predictor of Outcomes With Tarlatamab in Extensive-Stage Small Cell Lung Cancer
07/28/2026
Stephanie Holland
Results from the largest real-world analysis of tarlatamab to date demonstrated that baseline performance status was a major determinant of clinical outcomes in patients with previously treated extensive-stage small cell lung cancer, whereas...
Results from the largest real-world analysis of tarlatamab to date demonstrated that baseline performance status was a major determinant of clinical outcomes in patients with previously treated extensive-stage small cell lung cancer, whereas...
Results from the largest...
07/28/2026
Oncology

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