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Melanoma
Specialty Channel
FDA Approval
FDA Approves Vusolimogene Oderparepvec Plus Nivolumab for PD-1-Refractory Advanced Melanoma
08/06/2026
Emily Estrada
The FDA has granted accelerated approval to vusolimogene oderparepvec plus nivolumab for patients with unresectable advanced cutaneous melanoma that has progressed following PD-1-blockade, based on durable responses observed in the phase 2...
The FDA has granted accelerated approval to vusolimogene oderparepvec plus nivolumab for patients with unresectable advanced cutaneous melanoma that has progressed following PD-1-blockade, based on durable responses observed in the phase 2...
The FDA has granted accelerated...
08/06/2026
Oncology
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 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
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
First-Line Toripalimab Demonstrates Progression-Free Survival Benefit in Advanced Melanoma
02/11/2026
Stephanie Holland
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3...
02/11/2026
Oncology
News
Nivolumab Plus Relatlimab Demonstrates Long-Term Efficacy, Safety Among Newly Diagnosed Patients With Advanced Unresectable Melanoma
08/19/2025
Stephanie Holland
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the...
08/19/2025
Oncology
News
Neoadjuvant Pembrolizumab for Treatment-Naive Patients With Stage IIB/IIC Melanoma
06/17/2025
Stephanie Holland
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a...
06/17/2025
Oncology
News
Adjuvant Pembrolizumab Continues to Prolong Survival Outcomes Among Patients With Stage IIB/IIC Melanoma
05/12/2025
Stephanie Holland
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up...
05/12/2025
Oncology
News
Addition of Short-Term Targeted Therapy Provides Long-Term Survival Benefit for Patients With Advanced Melanoma
05/06/2025
Stephanie Holland
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival...
05/06/2025
Oncology

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 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
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
First-Line Toripalimab Demonstrates Progression-Free Survival Benefit in Advanced Melanoma
02/11/2026
Stephanie Holland
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3...
02/11/2026
Oncology
News
Nivolumab Plus Relatlimab Demonstrates Long-Term Efficacy, Safety Among Newly Diagnosed Patients With Advanced Unresectable Melanoma
08/19/2025
Stephanie Holland
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the...
08/19/2025
Oncology
News
Neoadjuvant Pembrolizumab for Treatment-Naive Patients With Stage IIB/IIC Melanoma
06/17/2025
Stephanie Holland
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a...
06/17/2025
Oncology
News
Adjuvant Pembrolizumab Continues to Prolong Survival Outcomes Among Patients With Stage IIB/IIC Melanoma
05/12/2025
Stephanie Holland
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up...
05/12/2025
Oncology
News
Addition of Short-Term Targeted Therapy Provides Long-Term Survival Benefit for Patients With Advanced Melanoma
05/06/2025
Stephanie Holland
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival...
05/06/2025
Oncology

Interactive Features

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
Quiz
Quiz: Does Pembrolizumab Plus Ipilimumab Lead to Antitumor Activity in Melanoma?
08/26/2021
True or false: In a recent phase 2 trial, pembrolizumab plus low-dose ipilimumab demonstrated antitumor activity and tolerability for patients with melanoma after anti-PD-1 immunotherapy failure.
True or false: In a recent phase 2 trial, pembrolizumab plus low-dose ipilimumab demonstrated antitumor activity and tolerability for patients with melanoma after anti-PD-1 immunotherapy failure.
True or false: In a recent phase...
08/26/2021
Oncology
Test Your Knowledge
Quiz: Nomograms Developed to Predict Recurrences in Patients with T1 Melanomas
03/26/2021
True or False: The nomograms in this study can identify T1 melanoma patients at higher risk of either local, regional or distant recurrence.
True or False: The nomograms in this study can identify T1 melanoma patients at higher risk of either local, regional or distant recurrence.
True or False: The nomograms in...
03/26/2021
Oncology
Test Your Knowledge
Quiz: Combining Low-Dose Ipilimumab With Pembrolizumab in Melanoma
06/22/2020
True or False: In a phase 2 study, combining low-dose ipilimumab with pembrolizumab led to significant antitumor activity in patients with melanoma that progressed with a PD1 antibody.
True or False: In a phase 2 study, combining low-dose ipilimumab with pembrolizumab led to significant antitumor activity in patients with melanoma that progressed with a PD1 antibody.
True or False: In a phase 2...
06/22/2020
Oncology
Test Your Knowledge
Quiz: What Factors Increase Risk for AEs in Patients With Melanoma?
05/25/2020
True or False: The risk for immune-related adverse events in patients with advanced melanoma varies based on immune checkpoint inhibitor type and dose.
True or False: The risk for immune-related adverse events in patients with advanced melanoma varies based on immune checkpoint inhibitor type and dose.
True or False: The risk for...
05/25/2020
Oncology
Test Your Knowledge
Quiz: Can Adverse Events Indicate Pembrolizumab Activity in Stage III Melanoma?
03/06/2020
True or False: Immune-related adverse events can be indicative of pembrolizumab activity in patients with high-risk, stage III melanoma.
True or False: Immune-related adverse events can be indicative of pembrolizumab activity in patients with high-risk, stage III melanoma.
True or False: Immune-related...
03/06/2020
Oncology
Test Your Knowledge
Quiz: Mohs Micrographic Surgery vs Traditional Excision for Melanoma
02/13/2020
True or False: Compared with excision, Mohs micrographic surgery moderately improves overall survival in patients with early-stage invasive melanoma.
True or False: Compared with excision, Mohs micrographic surgery moderately improves overall survival in patients with early-stage invasive melanoma.
True or False: Compared with...
02/13/2020
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 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
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
First-Line Toripalimab Demonstrates Progression-Free Survival Benefit in Advanced Melanoma
02/11/2026
Stephanie Holland
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3 MELATORCH trial demonstrated that first-line toripalimab significantly improved progression-free survival compared with dacarbazine in patients with advanced melanoma, supporting PD-1 inhibition as an effective...
Results from the phase 3...
02/11/2026
Oncology
News
Nivolumab Plus Relatlimab Demonstrates Long-Term Efficacy, Safety Among Newly Diagnosed Patients With Advanced Unresectable Melanoma
08/19/2025
Stephanie Holland
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the phase 2/3 RELATIVITY-047 trial, nivolumab plus relatlimab demonstrated durable long-term efficacy and safety among newly diagnosed patients with advanced unresectable melanoma.
According to results from the...
08/19/2025
Oncology
News
Neoadjuvant Pembrolizumab for Treatment-Naive Patients With Stage IIB/IIC Melanoma
06/17/2025
Stephanie Holland
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a multicenter, phase 2 trial, neoadjuvant pembrolizumab demonstrated both efficacy and safety among patients with stage IIB/IIC melanoma without risking increased sentinel lymph node metastasis.
According to results from a...
06/17/2025
Oncology
News
Adjuvant Pembrolizumab Continues to Prolong Survival Outcomes Among Patients With Stage IIB/IIC Melanoma
05/12/2025
Stephanie Holland
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up results from the KEYNOTE-716 trial, adjuvant pembrolizumab continued to prolong survival outcomes among patients with stage IIB/IIC melanoma.
According to long-term follow-up...
05/12/2025
Oncology
News
Addition of Short-Term Targeted Therapy Provides Long-Term Survival Benefit for Patients With Advanced Melanoma
05/06/2025
Stephanie Holland
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival results from the IMPemBra trial, the addition of short-term targeted therapy to anti-PD1 inhibition demonstrated long-term survival benefit among treatment-naive patients with BRAFV600E/K-mutated advanced...
According to updated survival...
05/06/2025
Oncology
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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