Crizotinib

Nuvation Bio Announces Data from Pivotal Phase 2 TRUST-I Study of its Investigational ROS1 Inhibitor, Taletrectinib, are Published in the Journal of Clinical Oncology and Reported at 2024 ASCO Annual Meeting

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토요일, 6월 1, 2024
Biotechnology, General Health, Health, Pharmaceutical, Oncology, Safety, ASCO, Crizotinib, Vomiting, Diarrhea, Annual general meeting, NSCLC, NUVB, JCO, Society, Metastasis, Incidence, Professor, PFS, Corr, Disease, Journal, Dizziness, Abstract, Brain tumor, IRC, ROS1, Progression-free survival, Brain, Neoplasm, TKI, Anemia, Shanghai East Hospital, Phase, Tongji University, Pharmaceutical industry

Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.

Key Points: 
  • Data were reported from 173 patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) who were treated with taletrectinib.
  • After median follow-up of 23.5 months in TKI-naïve patients, median duration of response (IRC-assessed) and median progression-free survival (IRC-assessed) were not reached.
  • After median follow-up of 9.7 months in TKI-pretreated patients, median duration of response and median progression-free survival were 10.6 months and 7.6 months, respectively.
  • Taletrectinib’s safety profile was consistent with previous reports, with a low incidence of neurologic treatment-emergent adverse events (TEAEs).

Pfizer’s LORBRENA® CROWN Study Shows Majority of Patients with ALK-Positive Advanced Lung Cancer Living Beyond Five Years Without Disease Progression

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금요일, 5월 31, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Traffic barrier, Lung, Principal, Progression-free survival, Patient, Diarrhea, Anaplastic lymphoma kinase, Headache, Cough, Weight gain, Learning, Hypercholesterolemia, Risk, Hypertriglyceridemia, Inc., Lung cancer, Doctor of Philosophy, Arthralgia, PFS, Disease, Edema, NSCLC, APLS, Death, Peripheral neuropathy, HR, Abstract, Periodic breathing, Hypertension, PFE, ASCO, Journal, Brain, Society, ALK, Confidence interval, Aes, MBBS, Crizotinib, Pharmaceutical industry

Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.

Key Points: 
  • Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were alive without disease progression after five years compared to 8% (3-14) on the XALKORI treatment arm.
  • “These results from the CROWN trial are unprecedented, as the majority of patients on LORBRENA are living beyond five years without disease progression,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer.
  • “This updated analysis shows that LORBRENA helped patients live longer without disease progression, with the majority of patients experiencing sustained benefit for over five years, including nearly all patients having protection from progression of disease in the brain.
  • At the time of analysis, 50% of patients in the CROWN trial were still receiving LORBRENA compared to 5% of patients receiving XALKORI.

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting

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월요일, 4월 29, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PFS, Brentuximab vedotin, Triple-negative breast cancer, Lung cancer, MBC, ASCO, Lymphoma, PFE, Metastasis, ALK, Breast cancer, Learning, CRS, Food, Colorectal cancer, Abstract, RRMM, Rituximab, ADC, HR, CDK4, De novo, Spacecraft, DLBCL, Tucatinib, Anaplastic lymphoma kinase, Safety, Crizotinib, Pembrolizumab, Survival, EZH2, Pros, Inc., Neoplasm, Progression-free survival, Recurrence, PAL, Biologics license application, HRR, Hodgkin lymphoma, Patient, Society, Cyclin-dependent kinase 4, Cytokine release syndrome, Annual general meeting, APLS, PBC, Lenalidomide, B-cell lymphoma, Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.
  • “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive profile of TUKYSA in colorectal cancer.
  • Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting Friday, May 24.

Nuvalent Presents New Preclinical Data Supporting Profiles of HER2-Selective Inhibitor, NVL-330, and ROS1-Selective Inhibitor, Zidesamtinib, at AACR Annual Meeting 2024

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월요일, 4월 8, 2024
Penetrance, HER2, Mutagenesis, EGFR, Cell, Patient, CNS, Cancer, ENU, Human, Senior, TRK, AACR, Crizotinib, ROS1, Drug discovery, Vaccine

CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the presentation of new preclinical data for its novel HER2-selective inhibitor, NVL-330, and novel ROS1-selective inhibitor, zidesamtinib (NVL-520). The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego. The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.

Key Points: 
  • The two posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting taking place from April 5 – 10 in San Diego.
  • The posters will also be available on the Nuvalent website at www.nuvalent.com following the presentations.
  • "Today's presentations continue to reinforce the differentiated profiles of our drug candidates," said Henry Pelish, Ph.D., Senior Vice President of Drug Discovery at Nuvalent.
  • These mutagenesis screens provide additional preclinical support for zidesamtinib's potential to drive deep and durable responses for patients with ROS1-driven cancers.

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

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수요일, 3월 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Brain, NSCLC, New Drug Application, Patient, JAMA Oncology, NDA, Anaplastic lymphoma kinase, Crizotinib, Safety, File, Holding, Food, ALK, PDUFA, Pharmaceutical industry

Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Key Points: 
  • Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
  • The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC.
  • The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
  • In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile.

BlossomHill Therapeutics Chief Executive Officer, Jingrong Jean Cui, Ph.D., Elected to the National Academy of Engineering

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수요일, 2월 14, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Engineering, Manufacturing, Pfizer, Education, FDA, Crizotinib, National academy, Entrepreneurship, Bristol Myers Squibb, NAE, Therapy, Cancer, Pharmaceutical industry

BlossomHill Therapeutics , a biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, today announced Jingrong Jean Cui, Ph.D., Co-Founder, President and Chief Executive Officer of BlossomHill Therapeutics, has been elected to the National Academy of Engineering (NAE).

Key Points: 
  • BlossomHill Therapeutics , a biotechnology company focused on the design and development of small molecule medicines for treating cancer and autoimmune diseases, today announced Jingrong Jean Cui, Ph.D., Co-Founder, President and Chief Executive Officer of BlossomHill Therapeutics, has been elected to the National Academy of Engineering (NAE).
  • The prestigious honor recognizes Dr. Cui’s direct role in the innovation of new medicines to fight cancer and address urgent medical needs.
  • As Co-Founder, President and Chief Executive Officer of BlossomHill Therapeutics, Dr. Cui leads the effort to design the novel small molecule drug candidates in the company’s R&D pipeline.
  • Prior to BlossomHill, Dr. Cui co-founded Turning Point Therapeutics, Inc., which Bristol Myers Squibb acquired in June 2022 for $4.1 billion.

Genprex Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators

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수요일, 2월 7, 2024
Transfer, AACR, TUSC2, Toxicity, Survival, Cell, Research, NSCLC, DNA, NPRL2, Mitochondrion, Lung cancer, Gene, Patient, FDA, ALK, Mouse, Food, Crizotinib, Diabetes, Risk, Biology, Metabolism, Meharry Medical College, Cancer, University, Malignancy, Vaccine

AUSTIN, Texas, Feb. 7, 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 the expansion of its nonclinical programs into new indications through Sponsored Research Agreements and Material Transfer Agreements with multiple academic research collaborators to study TUSC2, the tumor suppressor gene used in Genprex's lead drug candidate, REQORSA (quaratusugene ozeplasmid), and NPRL2, another tumor suppressor gene. The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.

Key Points: 
  • The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.
  • "Research indicates that the TUSC2 gene used in REQORSA may benefit many types of cancers and potentially the treatment of other diseases.
  • Research collaborators at the Rogel Cancer Center's Judith Tam ALK Lung Cancer Research Initiative are studying the combination of Genprex's REQORSA, which uses the TUSC2 tumor suppressor gene, with various ALK inhibitors.
  • 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.

Viracta Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update

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월요일, 8월 14, 2023
Lymphoma, PTCL, Patent, Peripheral T-cell lymphoma, Extranodal NK/T-cell lymphoma, nasal type, Probability, Drug development, Hematology, Creatinine, DLBCL, Crizotinib, Valganciclovir, United States patent law, G&A, CMO, B-cell lymphoma, Stage 2, Transplant, Journal, American Society of Hematology, State, Patient, Investment, Cytopenia, EBV, Bone marrow, T-cell lymphoma, Financial toxicity, R, Research, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patent and Trademark Office, Stomach, Society, Food, Pharmaceutical industry, Vaccine, Platinum, Fine chemical, Leiomyosarcoma, Lymphoepithelioma

“In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.

Key Points: 
  • “In the second quarter of 2023, we achieved key milestones in the pivotal NAVAL-1 study of Nana-val by enabling the advancement of this global clinical trial into Stage 2 and establishing EBV-positive PTCL as Nana-val’s leading indication.
  • Prioritization also enables the allocation of resources to those indications with the greatest probability of success and market opportunity in key geographies.
  • Patients with extranodal NK/T-cell lymphoma (ENKTL) and other ultra-rare subtypes of EBV+ lymphoma will continue to be enrolled.
  • In July 2023, Viracta received a Notice of Allowance from the US Patent and Trademark Office on Viracta’s patent claims directed to a next-generation formulation of nanatinostat.

Viracta Therapeutics Appoints Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer

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월요일, 8월 7, 2023
Duke University Hospital, Drug development, Boston University Chobanian & Avedisian School of Medicine, Microbiology, Pharmacia, Doctor of Philosophy, Crizotinib, Clinical trial, CMO, Boston University School of Public Health, Patient, Georgetown University Medical Center, SAN, Internal medicine, Cell, Sanofi, Jazz Pharmaceuticals, Bone marrow, Therapy, EBV, Pharmaceutical industry, Medicine, Pfizer

SAN DIEGO, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer (CMO), effective immediately.

Key Points: 
  • SAN DIEGO, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced the appointment of Darrel P. Cohen, M.D., Ph.D. as Chief Medical Officer (CMO), effective immediately.
  • Dr. Cohen will oversee the clinical development and regulatory advancement of Nana-val in Epstein-Barr virus (EBV)-associated malignances, contribute to the strategic expansion of Viracta’s pipeline, and serve on the Executive Leadership Team.
  • Prior to this, Dr. Cohen was CMO at Biosight Pharmaceuticals and Head of Clinical Development at EUSA Pharma.
  • and Ph.D. degrees in Medicine and Microbiology from Boston University School of Medicine, trained as a resident in Internal Medicine at Georgetown University Medical Center, and completed a fellowship in hematology/oncology at Duke University Medical Center.

Acrivon Therapeutics Announces the Appointment of Seasoned Biopharma Executive Charles Baum, M.D., Ph.D., a Recognized Leader in Clinical Precision Oncology, to its Board of Directors

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목요일, 6월 22, 2023
Odyssey, Partnership, Drug development, Doctor of Philosophy, Stanford University, Crizotinib, ACRV, Schering-Plough, Mirati Therapeutics, Neoplasm, Breast, Medicine, AP3, Research, Bangladesh Technical Education Board, Lung, Development, Patient, Patent, Washington University School of Medicine, Growth, American Cancer Society, Axitinib, Phase, Therapy, Pharmaceutical industry, Pfizer, Mirati

“We are thrilled about Chuck’s appointment and look forward to his contributions to the board,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.

Key Points: 
  • “We are thrilled about Chuck’s appointment and look forward to his contributions to the board,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon.
  • “Chuck is a highly accomplished leader in our industry who has excelled as both a business executive as well as a precision oncology drug developer.
  • He founded Mirati Therapeutics where he built a world class oncology team resulting in the approval of its best-in-class KRASG12C inhibitor.
  • Dr. Baum serves on the board of directors at PMV Pharmaceuticals, Inc., Odyssey Therapeutics and Poseida Therapeutics.