Glioma

Apollomics Announces Approval of Vebreltinib in China as a First-in-Class Treatment for Gliomas with MET Fusion Gene

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목요일, 4월 25, 2024
Glioma, Shanda, MET, WHO, Temozolomide, Safety, Risk, NMPA, National Medical Products Administration, Glioblastoma, Isocitrate dehydrogenase, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Partnership, Trial of the century, Etoposide, OS, History, CNS, IDH, Patient, Neoplasm, Met, APLM, NSCLC, Lung cancer, Pharmaceutical industry

FOSTER CITY, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM), a clinical-stage biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, today announced that its partner in China, Avistone Biotechnology Co. Ltd. (Avistone), received approval from the National Medical Products Administration (NMPA) of China for vebreltinib (APL-101) for the treatment of adult patients with isocitrate dehydrogenase (IDH) mutant astrocytoma (WHO Grade 4) or glioblastoma with a history of low-grade disease who have the PTPRZ1-MET fusion (ZM fusion) gene and have failed previous treatments. This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration, and follows the NMPA’s November 2023 approval of vebreltinib for the treatment of patients with Met Exon 14 skipping non-small cell lung cancer (NSCLC).

Key Points: 
  • "The NMPA’s approval of vebreltinib in gliomas is an important, first-in-class approval as it demonstrates vebreltinib’s CNS penetration ability and c-Met inhibitory activity in the tumors there," said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics.
  • Surgery, radiation treatment, and chemotherapy are current standard treatment strategies for gliomas with poor prognoses.
  • These preliminary data support cross-region similarity of patient response to treatment with vebreltinib.
  • This collaboration enables both companies to leverage their strengths and maximize the benefit of vebreltinib worldwide.

XOMA Earns $9 Million Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)

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목요일, 4월 25, 2024
FDA, Glioma, NDA, Food, Economics, New Drug Application, BRAF, Patient, Therapy, LGG, BRAF V600, Pharmaceutical industry

EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. 

Key Points: 
  • First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
    EMERYVILLE, Calif., April 25, 2024 (GLOBE NEWSWIRE) -- XOMA Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today it has earned a $9 million milestone related to the U.S. Food and Drug Administration’s (FDA) approval of Day One Biopharmaceuticals’ New Drug Application (NDA) for OJEMDA™ (tovorafenib) for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
  • “This is an important milestone for XOMA and our royalty portfolio, but more importantly, it is a watershed event for children living with low-grade gliomas with BRAF alterations that have relapsed or progressed,” stated Owen Hughes, Chief Executive Officer of XOMA.
  • In March 2021, XOMA paid $13.5 million upfront to acquire the $54 million in potential milestones and mid-single digit royalties associated with tovorafenib, plus a share of potential event-based economics, in addition to the economics associated with vosaroxin, from Viracta Therapeutics.

TLX101-CDx (Pixclara™) Granted FDA Fast Track Designation

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월요일, 4월 15, 2024
FDA, University, Fast Track, Pharmacy, Food and Drug Administration, TLX, NDA, Food, Radiology, MD, ASX, PET, Partnership, Research, Glioma, UCSF, Patient, FET, Radiopharmaceutical, 18F-FET, Diagnosis

MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).

Key Points: 
  • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company’s investigational glioma imaging product, TLX101-CDx (Pixclara™2, 18F-floretyrosine or 18F-FET).
  • The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET).
  • Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.
  • This designation enables expedited review and closer consultation with the FDA during the review process.

Avistone Announces the Approval of Vebreltinib as the First MET-TKI Treatment for a Rare Brain Glioma Subtype in China

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목요일, 4월 25, 2024
Oncology, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Glioma, Shanda, MET, Temozolomide, Safety, Radiation, NMPA, Glioblastoma, Isocitrate dehydrogenase, Prognosis, Survival, New Drug Application, Cisplatin, Death, Central nervous system, Lung cancer, Etoposide, OS, History, Risk, CNS, Therapy, IDH, Patient, Neoplasm, NSCLC, Pharmaceutical industry

This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.

Key Points: 
  • This supplemental New Drug Application (sNDA) approval makes vebreltinib the world’s first c-Met inhibitor approved for treatment of Central Nervous System (CNS) tumor with c-Met alteration.
  • In November 2023, vebreltinib received conditional approval for the treatment of metastatic patients with MET Exon14 Skipping non-small cell lung cancer (NSCLC) from the NMPA.
  • Glioma is a refractory primary malignant intracranial tumor, accounting for approximately 46% of intracranial tumors [1].
  • The approval of vebreltinib for the ZM fusion-positive glioma indications is based on the positive results of the FUGEN study (NCT06105619).

PNOC FOUNDATION, A LEADING NON-PROFIT TO FURTHER ADVANCEMENTS IN PEDIATRIC BRAIN CANCER, ANNOUNCES FDA APPROVAL OF TOVORAFENIB (DAY101) IN PARTNERSHIP WITH PNOC SCIENTIFIC CONSORTIUM AND DAY ONE BIOPHARMACEUTICALS

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수요일, 4월 24, 2024
FDA, Glioma, Patient, Clinical trial, Brain, Research, BRAF, Pediatrics, PNOC, Platinum, Pharmaceutical industry

SAN RAFAEL, Calif., April 24, 2024 /PRNewswire/ -- The Pediatric Neuro-Oncology Consortium Foundation (PNOC Foundation), a platinum rated non-profit dedicated to supporting advancements in childhood brain cancer research and clinical trials, announces the FDA approval of Tovorafenib (DAY101), a significant advancement in the fight against pediatric low-grade glioma brain tumors. This approval is a direct result of the pivotal Phase 2 FIREFLY-1 trial/PNOC026, which demonstrated meaningful responses and a favorable safety profile, marking a promising development in pediatric neuro-oncology. This trial built on the initial PNOC phase 1 trial, PNOC014.

Key Points: 
  • This approval marks a significant milestone as the first and only FDA-approved medicine for children with BRAF fusions or rearrangements in pediatric low-grade glioma.
  • "This is a landmark development for pediatric brain cancer research and treatment," said PNOC Foundation co-founder and patient parent Bruce Campbell.
  • This is a victory for kids and their families fighting pediatric low-grade gliomas, however, there is still a huge unmet need.
  • "Seeing the promise of PNOC realized with advancements like Tovorafenib confirms the crucial role of our foundation," stated Allyn Campbell, co-founder of the PNOC Foundation.

Orphan designation: Thiophene methylimidazole pentahydrogen Diagnosis of glioma, 12/01/2024 Positive

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목요일, 4월 18, 2024
Diagnosis, Patient, Committee, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the diagnosis of glioma on 12 January 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: carboplatin Treatment of glioma, 19/02/2024 Positive

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목요일, 4월 18, 2024
Patient, Committee, Carboplatin, Glioma, EMA, IRIS, COMP, European Commission, Marketing, Medicine, Pharmaceutical industry

Overview

Key Points: 
  • Overview
    This medicine was designated as an orphan medicine for the treatment of glioma on 19 February 2024.
  • Orphan designation does not mean the medicine is available or authorised for use.
  • All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

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화요일, 4월 9, 2024
Eurostat, Diagnosis, Civil service commission, Radiation, Personality, Brain, Headache, MRI, 18F, Aminolevulinic acid, Cell, Survival, Disease, Seizure, Magnetic resonance imaging, Patient, Committee, Knowledge, Glioma, PET, Tissue, Regulation, Cancer, FDOPA, EMA, IRIS, Nausea, European, Fluorodeoxyglucose (18F), COMP, Somatic symptom disorder, Sponsor, European Commission, Safety, Vomiting, Marketing, Hepatocellular carcinoma, Molecular imaging, Medicine, Pharmaceutical industry

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Key Points: 


Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Genprex Collaborators Publish Positive Preclinical Data with NPRL2 Gene Therapy Utilizing Oncoprex® Delivery System

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화요일, 4월 2, 2024
TUSC2, Toxicity, LLC2, Gene, Growth, NSCLC, Diabetes, Risk, Patient, Lung, Neoplasm, Glioma, Mouse, Manuscript, Cancer, Pembrolizumab, NPRL2, Lung cancer, Stomach, BioRxiv, Hepatocellular carcinoma, NK, Natural killer T cell

AUSTIN, Texas, April 2, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators have published positive preclinical data for the NPRL2 tumor suppressor gene, utilizing the Company's non-viral Oncoprex® Delivery System, in KRAS/STK11 mutant anti-PD1 resistant non-small cell lung cancer (NSCLC) in a humanized mouse model.

Key Points: 
  • Genprex's Oncoprex® Delivery System is a novel non-viral approach that utilizes lipid-based nanoparticles in a lipoplex form to deliver tumor suppressor genes deleted during the course of cancer development.
  • Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.
  • "These positive preclinical data are very encouraging and support NPRL2 gene therapy as a potential treatment for a sub-group of NSCLC in which patients traditionally are resistant to existing therapies," said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
  • In conclusion, researchers reported that NPRL2 gene therapy induces anti-tumor activity through dendritic cell-mediated antigen presentation and cytotoxic immune cell activation.

73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis

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금요일, 3월 29, 2024
ODD, Lung cancer, HER2, Epothilone, Survival, Prognosis, Brain, BBB, Central nervous system, Synthetic biology, Patient, SAN, CNS, Etoposide, Triple-negative breast cancer, Glioma, Traffic barrier, CBR, Bevacizumab, Breast cancer, PFS, FDA, TNBC

As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].

Key Points: 
  • As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1].
  • Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux.
  • The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data.
  • Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year.