Etoposide

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

Retrieved on: 
Thursday, April 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.

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

Retrieved on: 
Thursday, April 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).

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

Retrieved on: 
Friday, March 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.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023
Health, Science, Pharmaceutical, Research, Clinical Trials, Carboplatin, Chemotaxis, Waldenström macroglobulinemia, AstraZeneca, BTK, MCL, Rituximab, B-cell lymphoma, Patient, Ifosfamide, ABC, SWOT, EU4, Etoposide, Follicular lymphoma, Acalabrutinib, Waldenström, RICE, CLL, Axicabtagene ciloleucel, Risk management, Pharmaceutical industry, DLBCL, Phase

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

Takeda to Present Data at 65th American Society of Hematology (ASH) Annual Meeting, Demonstrating Continued Commitment to Patients with Hematologic Diseases

Retrieved on: 
Monday, November 27, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Dexamethasone, Doxorubicin, Multiple myeloma, Food and Drug Administration, Genetics, Safety, Toll, Food, Haemophilia, Sickle cell disease, ASH, Bone marrow, ADAMTS13, Prednisone, Meta-analysis, Leukemia, Patient, Brentuximab vedotin, Bleomycin, FDA, Etoposide, Pharmacokinetics, Vincristine, Dacarbazine, 65th Infantry Regiment, Cyclophosphamide, Society, Procarbazine, Environment, Lymphoma, Pharmaceutical industry, Medical imaging, Takeda, Hematology

Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.
  • Takeda’s latest research focuses on improving treatment options for those living with hematologic diseases.
  • “Our aspiration is to deliver life-transforming medicines for difficult-to-diagnose, rare hematologic diseases with high unmet patient need,” said Björn Mellgård, M.D., Ph.D., vice president and global program lead of Rare Genetics and Hematology at Takeda.
  • “Our continued research aims to improve long-term outcomes for patients suffering from these conditions.

OncoHost's PROphet® Platform to Support Henlius US-Based Phase III Trial for Patients with Extensive-Stage Small Cell Lung Cancer

Retrieved on: 
Tuesday, October 3, 2023
Probability, IgG4-related ophthalmic disease, Therapy, Progression-free survival, Cancer, Data collection, Biomarker, Inflammation, Carboplatin, Immunotherapy, Inflammatory bowel disease, Etoposide, Protein, Mechanism, MD, Patient, Machine learning, Medicine, Mall of America, Caregiver, Safety, Disease, Pharmaceutical industry, OS

BINYAMINA, Israel , Oct. 3, 2023 /PRNewswire/ -- OncoHost, a technology company transforming the approach to precision medicine for improved patient outcomes, today announced a collaboration with Hengenix Biotech, Inc. (Henlius USA), affiliated with Shanghai Henlius Biotech, Inc., a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Henlius USA will utilize OncoHost's PROphet® platform to identify exploratory, correlative biomarkers for patients recruited in its comprehensive Phase III clinical trial (NCT05468489). The trial is evaluating the efficacy and safety of Serplulimab plus chemotherapy (carboplatin - etoposide) in previously untreated US-based patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

Key Points: 
  • Henlius USA will utilize OncoHost's PROphet® platform to identify exploratory, correlative biomarkers for patients recruited in its comprehensive Phase III clinical trial ( NCT05468489 ).
  • The trial is evaluating the efficacy and safety of Serplulimab plus chemotherapy (carboplatin - etoposide) in previously untreated US-based patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
  • "Our shared goal is to improve cancer patients' outcomes by developing robust, scientifically sound technologies to support them and their caregivers.
  • We believe that such collaborations hold the potential to bring new hope to those affected by this challenging disease."

AUA Releases Amendment to the Diagnosis and Treatment of Early-Stage Testicular Cancer Guideline

Retrieved on: 
Thursday, September 14, 2023
Cancer, IIB, Teratoma, Guideline, Retroperitoneal space, AUA, IIA, American Urological Association, Bleomycin, Toxicity, Cisplatin, Literature, SUFU, Testicular cancer, Etoposide, Estate (law), Patient, Surveillance, Diagnosis, Rush University Medical Center, Tumor antigen, ULR, Dentistry, Medical imaging, Medical device

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.

Key Points: 
  • BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.
  • Testicular cancer is the most common solid malignancy in young males and is relatively rare, with outcomes defined by specific cancer and patient-related factors.
  • "Since the last testicular cancer guideline was released, the model for management has substantially changed, making an amendment like this critical to effectively treat and manage testicular cancer."
  • Diagnosis and treatment of early-stage testicular cancer: AUA Guideline amendment 2023.

Genprex Receives U.S. FDA Fast Track Designation for REQORSA® Immunogene Therapy in Combination with Tecentriq® for the Treatment of Small Cell Lung Cancer

Retrieved on: 
Wednesday, June 28, 2023
Maintenance, Diabetes, Progression-free survival, Maxima and minima, FTD, Survival, Cancer, Lung cancer, Fast Track, Toxicity, TUSC2, NSCLC, Index, Carboplatin, AstraZeneca, PFS, Non-small-cell lung cancer, Merck & Co., Etoposide, HIV disease progression rates, MD, Patient, MTD, Toxic leukoencephalopathy, Merck, Recommended maximum intake of alcoholic beverages, FDA, Pembrolizumab, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Disease, Pharmaceutical industry, Atezolizumab, SCLC

AUSTIN, Texas, June 28, 2023 /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 the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for the Company's lead drug candidate, REQORSA® Immunogene Therapy, in combination with Genentech, Inc.'s Tecentriq® in patients with extensive-stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment.

Key Points: 
  • We look forward to accelerating the clinical development of REQORSA, and potentially providing a new treatment option for patients with SCLC."
  • Virtually 100% of small cell lung cancers express decreased amounts of TUSC2 tumor suppressor protein, and 41% completely lack TUSC2 protein expression.
  • "This Fast Track Designation for the Acclaim-3 patient population is another validation of REQORSA's potential to treat lung cancer," said Mark Berger, MD, Chief Medical Officer at Genprex.
  • In addition, Fast Track product candidates could be eligible for priority review if supported by clinical data at the time of BLA submission.

Phase 3 Trial of ADCETRIS® (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma

Retrieved on: 
Tuesday, June 20, 2023
Science, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Other Health, Hodgkin lymphoma, Doxorubicin, Inc., Vincristine, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, Hematology, ABVD, ICML, Procarbazine, Survival, Lymphoma, PET, Cyclophosphamide, Bleomycin, ADCETRIS, CHL, PFS, Teaching hospital, Dexamethasone, FSH, Research and development, Dacarbazine, Prednisone, Development, Etoposide, International Conference on Nuclear Disarmament, Oslo, 2008, Patient, Risk, Progressive multifocal leukoencephalopathy, Fertility, BEACOPP, Peripheral neuropathy, Death, Society, Conference, Pharmaceutical industry, Birth control, Seagen

The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.

Key Points: 
  • The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.
  • 12-month post-treatment safety data were consistent with previously presented HD21 data results at the American Society of Hematology 2022 Annual Meeting.
  • Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Nurix Therapeutics Presents Data from Studies of Its Targeted Protein Degraders in B Cell Malignancies and Initiates Expansion of NX-2127 Phase 1b Trial in Diffuse Large B Cell Lymphoma and Mantle Cell Lymphoma Indications

Retrieved on: 
Wednesday, June 14, 2023
Lymphoma, CD79B, Central nervous system, University, PD, Chronic lymphocytic leukemia, Cytarabine, SC1, Follicular lymphoma, Lymphoid leukemia, Half-life, DLBCL, Hematology, ICML, IMCL, Non-Hodgkin lymphoma, Survival, Pharmacokinetics, Head, Absorption, BTK, CNS, Etoposide, International Conference on Emerging Infectious Diseases, Primary central nervous system lymphoma, Patient, UCSF, American Society of Hematology, Mantle cell lymphoma, SAN, Memorial Sloan Kettering Cancer Center, AUC, Mouse, Bone marrow, MCL, Therapy, Poster, Society, Conference, Safety, Vaccine, Pharmaceutical industry, Cmax

SAN FRANCISCO, June 14, 2023 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced the presentation of clinical and preclinical data from its targeted protein degradation programs, NX-5948 and NX-2127, which are being evaluated in ongoing Phase 1 clinical trials in patients with relapsed/refractory B cell malignancies. These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.

Key Points: 
  • These data are being presented at the 17th International Conference on Malignant Lymphoma (ICML) which is being held June 13-17, in Lugano, Switzerland.
  • Limitations of current covalent and non-covalent BTK inhibitors include the susceptibility to mutational escape as a basis for resistance.
  • Nurix’s BTK degraders have the potential to address these limitations of BTK inhibitors and provide a new therapeutic option for patients.
  • Nurix is announcing plans to initiate two new Phase 1b dose expansion cohorts in the ongoing Phase 1a/1b clinical trial of NX-2127 in patients with relapsed or refractory B-cell malignancies.