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NF1-PN Specialty Channel

NF1-PN
Specialty Channel

FDA Approval
FDA Grants Approval to Selumetinib for Adults With NF1 and Symptomatic, Inoperable Plexiform Neurofibromas
11/19/2025
Emily Estrada
On November 19, 2025, the FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, expanding its prior pediatric indication to adults based on results from the phase 3 KOMET trial.
On November 19, 2025, the FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, expanding its prior pediatric indication to adults based on results from the phase 3 KOMET trial.
On November 19, 2025, the FDA...
11/19/2025
Oncology
Angela Hirbe, MD, PhD; Julia Meade, MD; Carlos Romo, MD
Videos
Future Therapeutic Options in Neurofibromatosis Type 1 With Plexiform Neurofibromas
04/29/2025
Angela Hirbe, MD, PhD; Carlos Romo, MD; Julia Meade, MD
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including future research areas.
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including future research areas.
In this video, a panel of...
04/29/2025
Oncology
Angela Hirbe, MD, PhD; Julia Meade, MD; Carlos Romo, MD
Videos
Mirdametinib for Adult and Pediatric Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
04/29/2025
Angela Hirbe, MD, PhD; Carlos Romo, MD; Julia Meade, MD
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including data from the ReNeu trial.
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including data from the ReNeu trial.
In this video, a panel of...
04/29/2025
Oncology
Angela Hirbe, MD, PhD; Julia Meade, MD; Carlos Romo, MD
Videos
Potential Therapeutic Options for Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
04/29/2025
Angela Hirbe, MD, PhD; Carlos Romo, MD; Julia Meade, MD
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including the potential therapeutic options.
In this video, a panel of experts discuss the management of patients with neurofibromatosis type 1 with plexiform neurofibromas, including the potential therapeutic options.
In this video, a panel of...
04/29/2025
Oncology
News
Mirdametinib for Adult and Pediatric Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
11/12/2024
Allison Casey
According to a phase 2b trial, mirdametinib demonstrated significant confirmed objective response rates with deep and durable reductions of volume of target plexiform neurofibromas and clinically meaningful improvements to health-related...
According to a phase 2b trial, mirdametinib demonstrated significant confirmed objective response rates with deep and durable reductions of volume of target plexiform neurofibromas and clinically meaningful improvements to health-related...
According to a phase 2b trial,...
11/12/2024
Oncology
News
Management of Adverse Events Associated With Selumetinib for Pediatric Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
09/17/2024
Allison Casey
A panel of experts provided consensus recommendations on prevention, early detection, and management of adverse events potentially associated with selumetinib among pediatric patients with neurofibromatosis type 1 and plexiform neurofibromas.
A panel of experts provided consensus recommendations on prevention, early detection, and management of adverse events potentially associated with selumetinib among pediatric patients with neurofibromatosis type 1 and plexiform neurofibromas.
A panel of experts provided...
09/17/2024
Oncology
News
Hearing Loss Among Pediatric Patients with Neurofibromatosis Type 1
08/29/2024
Allison Casey
According to a review of audiometric data, the rate of hearing loss among patients with neurofibromatosis type 1 (NF1) compared to the general population was higher than expected.
According to a review of audiometric data, the rate of hearing loss among patients with neurofibromatosis type 1 (NF1) compared to the general population was higher than expected.
According to a review of...
08/29/2024
Oncology
News
Effect of Food on Selumetinib Dosing for Adolescent Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
08/01/2024
Allison Casey
In the phase 1 trial, the addition of a low-fat meal with doses of selumetinib did not significantly impact selumetinib exposure or gastrointestinal toxicities among adolescent patients with neurofibromatosis type 1 with plexiform...
In the phase 1 trial, the addition of a low-fat meal with doses of selumetinib did not significantly impact selumetinib exposure or gastrointestinal toxicities among adolescent patients with neurofibromatosis type 1 with plexiform...
In the phase 1 trial, the...
08/01/2024
Oncology
News
Selumetinib Shows Efficacy, Safety Among Pediatric and Adult Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma
07/09/2024
Allison Casey
According to a phase 2 study, selumetinib demonstrated efficacy among both children and adults with NF1 and inoperable plexiform neurofibromas, and in other manifestations.
According to a phase 2 study, selumetinib demonstrated efficacy among both children and adults with NF1 and inoperable plexiform neurofibromas, and in other manifestations.
According to a phase 2 study,...
07/09/2024
Oncology
News
Study Findings Show Considerable Disease Burden of NF1-PN Among Affected Patients
07/01/2024
Janelle Bradley
Findings from the real-world CASSIOPEA study show the considerable disease burden of neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) highlighting the importance of effective treatments for this patient population.
Findings from the real-world CASSIOPEA study show the considerable disease burden of neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) highlighting the importance of effective treatments for this patient population.
Findings from the real-world...
07/01/2024
Oncology

Recent News

FDA Approval
FDA Grants Approval to Selumetinib for Adults With NF1 and Symptomatic, Inoperable Plexiform Neurofibromas
11/19/2025
Emily Estrada
On November 19, 2025, the FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, expanding its prior pediatric indication to adults based on results from the phase 3 KOMET trial.
On November 19, 2025, the FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas, expanding its prior pediatric indication to adults based on results from the phase 3 KOMET trial.
On November 19, 2025, the FDA...
11/19/2025
Oncology
News
Mirdametinib for Adult and Pediatric Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
11/12/2024
Allison Casey
According to a phase 2b trial, mirdametinib demonstrated significant confirmed objective response rates with deep and durable reductions of volume of target plexiform neurofibromas and clinically meaningful improvements to health-related...
According to a phase 2b trial, mirdametinib demonstrated significant confirmed objective response rates with deep and durable reductions of volume of target plexiform neurofibromas and clinically meaningful improvements to health-related...
According to a phase 2b trial,...
11/12/2024
Oncology
News
Management of Adverse Events Associated With Selumetinib for Pediatric Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
09/17/2024
Allison Casey
A panel of experts provided consensus recommendations on prevention, early detection, and management of adverse events potentially associated with selumetinib among pediatric patients with neurofibromatosis type 1 and plexiform neurofibromas.
A panel of experts provided consensus recommendations on prevention, early detection, and management of adverse events potentially associated with selumetinib among pediatric patients with neurofibromatosis type 1 and plexiform neurofibromas.
A panel of experts provided...
09/17/2024
Oncology
News
Hearing Loss Among Pediatric Patients with Neurofibromatosis Type 1
08/29/2024
Allison Casey
According to a review of audiometric data, the rate of hearing loss among patients with neurofibromatosis type 1 (NF1) compared to the general population was higher than expected.
According to a review of audiometric data, the rate of hearing loss among patients with neurofibromatosis type 1 (NF1) compared to the general population was higher than expected.
According to a review of...
08/29/2024
Oncology
News
Effect of Food on Selumetinib Dosing for Adolescent Patients With Neurofibromatosis Type 1 With Plexiform Neurofibromas
08/01/2024
Allison Casey
In the phase 1 trial, the addition of a low-fat meal with doses of selumetinib did not significantly impact selumetinib exposure or gastrointestinal toxicities among adolescent patients with neurofibromatosis type 1 with plexiform...
In the phase 1 trial, the addition of a low-fat meal with doses of selumetinib did not significantly impact selumetinib exposure or gastrointestinal toxicities among adolescent patients with neurofibromatosis type 1 with plexiform...
In the phase 1 trial, the...
08/01/2024
Oncology
News
Selumetinib Shows Efficacy, Safety Among Pediatric and Adult Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma
07/09/2024
Allison Casey
According to a phase 2 study, selumetinib demonstrated efficacy among both children and adults with NF1 and inoperable plexiform neurofibromas, and in other manifestations.
According to a phase 2 study, selumetinib demonstrated efficacy among both children and adults with NF1 and inoperable plexiform neurofibromas, and in other manifestations.
According to a phase 2 study,...
07/09/2024
Oncology
News
Study Findings Show Considerable Disease Burden of NF1-PN Among Affected Patients
07/01/2024
Janelle Bradley
Findings from the real-world CASSIOPEA study show the considerable disease burden of neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) highlighting the importance of effective treatments for this patient population.
Findings from the real-world CASSIOPEA study show the considerable disease burden of neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) highlighting the importance of effective treatments for this patient population.
Findings from the real-world...
07/01/2024
Oncology
News
Vinblastine/Methotrexate Fails to Demonstrate Activity for NF1-PN in Pediatric and Young-Adult Patients
07/01/2024
Janelle Bradley
Findings from a phase 2 study show vinblastine/methotrexate did not demonstrate activity for neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) in pediatric and young-adult patients, despite being well-tolerated.
Findings from a phase 2 study show vinblastine/methotrexate did not demonstrate activity for neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) in pediatric and young-adult patients, despite being well-tolerated.
Findings from a phase 2 study...
07/01/2024
Oncology
News
Health-Related Quality of Life Among Adult Patients With NF1-PN and Caregivers
07/01/2024
Janelle Bradley
Study findings show neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) worsens adult patient and caregiver health-related quality of life vs that of the general population.
Study findings show neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN) worsens adult patient and caregiver health-related quality of life vs that of the general population.
Study findings show...
07/01/2024
Oncology
News
Selumetinib for Managing NF1-PN in Pediatric Patients at Risk for Developing Tumor-Related Morbidity
07/01/2024
Janelle Bradley
Among pediatric patients with neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN), treatment with selumetinib resulted in significant shrinkage in PN without any clinically significant morbidity.
Among pediatric patients with neurofibromatosis type 1 with plexiform neurofibromas (NF1-PN), treatment with selumetinib resulted in significant shrinkage in PN without any clinically significant morbidity.
Among pediatric patients with...
07/01/2024
Oncology
News
Incidence of Cutaneous Squamous Cell Carcinoma and Carcinoma in Situ Continues to Rise
01/29/2026
Stephanie Holland
Results from a real-world analysis have demonstrated that the incidence of cutaneous squamous cell carcinoma and cutaneous squamous cell carcinoma in situ has steadily increased over the past 2 decades, emphasizing the need for monitoring...
Results from a real-world analysis have demonstrated that the incidence of cutaneous squamous cell carcinoma and cutaneous squamous cell carcinoma in situ has steadily increased over the past 2 decades, emphasizing the need for monitoring...
Results from a real-world...
01/29/2026
Oncology
News
Elenagen Plus Gemcitabine Improves Overall Survival for Patients With Platinum-Resistant Ovarian Cancer
01/29/2026
Emily Estrada
The addition of elenagen to gemcitabine therapy significantly prolonged overall survival among patients with platinum-resistant ovarian cancer without increasing toxicity, according to results from a phase 2 trial.
The addition of elenagen to gemcitabine therapy significantly prolonged overall survival among patients with platinum-resistant ovarian cancer without increasing toxicity, according to results from a phase 2 trial.
The addition of elenagen to...
01/29/2026
Oncology
News
Axicabtagene Ciloleucel Plus Atezolizumab Demonstrates Promise in Relapsed/Refractory Large B-Cell Lymphoma
01/28/2026
Stephanie Holland
Results from the phase 1/2 ZUMA-6 trial showed that the addition of atezolizumab to axicabtagene ciloleucel showed promising clinical activity among patients with relapsed or refractory large B-cell lymphoma.
Results from the phase 1/2 ZUMA-6 trial showed that the addition of atezolizumab to axicabtagene ciloleucel showed promising clinical activity among patients with relapsed or refractory large B-cell lymphoma.
Results from the phase 1/2...
01/28/2026
Oncology
News
Advances in Antibody-Based Therapies for the Treatment of Relapsed Small-Cell Lung Cancer
01/27/2026
Gina Tomaine
Antibody-based therapies are reshaping the treatment paradigm for relapsed SCLC by enabling antigen-specific targeting with clinically meaningful activity beyond traditional chemotherapy, according to findings from a comprehensive review.
Antibody-based therapies are reshaping the treatment paradigm for relapsed SCLC by enabling antigen-specific targeting with clinically meaningful activity beyond traditional chemotherapy, according to findings from a comprehensive review.
Antibody-based therapies are...
01/27/2026
Oncology
News
Tucatinib Plus Trastuzumab Shows Durable Efficacy and Manageable Safety for HER2-Posititive Metastatic Colorectal Cancer: MOUNTAINEER Trial
01/27/2026
Emily Estrada
Tucatinib plus trastuzumab provided durable responses and a favorable safety profile among patients with chemotherapy-refractory, HER2positive metastatic colorectal cancer, based on results from the phase 2 MOUNTAINEER trial.
Tucatinib plus trastuzumab provided durable responses and a favorable safety profile among patients with chemotherapy-refractory, HER2positive metastatic colorectal cancer, based on results from the phase 2 MOUNTAINEER trial.
Tucatinib plus trastuzumab...
01/27/2026
Oncology
News
TOMOX-Bevacizumab Combination Shows Feasibility as Second-Line Therapy in mCRC
01/27/2026
Emily Estrada
A TOMOX-bevacizumab combination demonstrated an acceptable safety profile as a second-line treatment for patients with metastatic colorectal cancer progressing after irinotecan-based chemotherapy, according to a phase 2 study.
A TOMOX-bevacizumab combination demonstrated an acceptable safety profile as a second-line treatment for patients with metastatic colorectal cancer progressing after irinotecan-based chemotherapy, according to a phase 2 study.
A TOMOX-bevacizumab combination...
01/27/2026
Oncology
News
ISL1 Emerges as a Potential Predictive Biomarker for Efficacy of Lurbinectedin in Relapsed SCLC
01/27/2026
Gina Tomaine
A translational study identified ISL1 as a potential predictive biomarker in small cell lung cancer, defining a subtype with enhanced sensitivity to lurbinectedin and supporting biomarker-driven patient selection in future trials.
A translational study identified ISL1 as a potential predictive biomarker in small cell lung cancer, defining a subtype with enhanced sensitivity to lurbinectedin and supporting biomarker-driven patient selection in future trials.
A translational study identified...
01/27/2026
Oncology
News
CSF-1-Targeted Therapies Continue to Redefine Systemic Treatment for TGCT
01/26/2026
Gina Tomaine
Systemic CSF-1R inhibition provides an effective option for unresectable or recurrent tenosynovial giant cell tumor, with safety and tolerability favoring newer agents and potentially shifting first-line treatment paradigms.
Systemic CSF-1R inhibition provides an effective option for unresectable or recurrent tenosynovial giant cell tumor, with safety and tolerability favoring newer agents and potentially shifting first-line treatment paradigms.
Systemic CSF-1R inhibition...
01/26/2026
Oncology
News
Sacituzumab Govitecan Plus Pembrolizumab Significantly Prolongs PFS in PD-L1-Positive Triple-Negative Breast Cancer
01/22/2026
Stephanie Holland
Results from the phase 3 ASCENT-04 trial demonstrate that sacituzumab govitecan plus pembrolizumab significantly prolongs PFS compared to pembrolizumab plus chemotherapy among previously untreated patients with advanced, PD-L1–positive...
Results from the phase 3 ASCENT-04 trial demonstrate that sacituzumab govitecan plus pembrolizumab significantly prolongs PFS compared to pembrolizumab plus chemotherapy among previously untreated patients with advanced, PD-L1–positive...
Results from the phase 3...
01/22/2026
Oncology
News
Anbenitamab Plus Chemotherapy After Trastuzumab Failure in HER2-Positive G/GEJ Cancer
01/21/2026
Stephanie Holland
Results from a multicenter, phase 3 trial demonstrated that anbenitamab plus chemotherapy improved survival compared with placebo plus chemotherapy among previously treated patients with HER2-positive gastric or gastroesophageal junction...
Results from a multicenter, phase 3 trial demonstrated that anbenitamab plus chemotherapy improved survival compared with placebo plus chemotherapy among previously treated patients with HER2-positive gastric or gastroesophageal junction...
Results from a multicenter,...
01/21/2026
Oncology

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