Gefitinib

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer

Retrieved on: 
Monday, February 19, 2024
Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical Trials, Metabolism, Immunotherapy, AstraZeneca, News, Daiichi Sankyo, National Cancer Institute, Lung cancer, Triple-negative breast cancer, Immunology, Patient, Cleavage, Biopharmaceutical, Social media, Progression-free survival, Treatment, BLA, Docetaxel, IHC, DXD, Pharmacotherapy, NSCLC, Breast cancer, Gefitinib, PD-1, Safety, Lung, Pemetrexed, PFS, American Cancer Society, Pircher, Observational study, MD, Sapporo Medical University, Food, Cancer, ADC, OS, Immunoglobulin G, Death, Medicine, Pharmaceutical industry

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

Key Points: 
  • AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.
  • In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favorable OS trend.
  • Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

EGFR Tests Market Forecasts to 2033: Comprehensive Analysis of Size, Share, Regulatory Landscape and Global Trends - ResearchAndMarkets.com

Retrieved on: 
Friday, December 22, 2023
Medical Devices, Health, Naʽat, Metastasis, Point mutation, Woman, Afatinib, Country, Male, Smoking, EGFR, SWOT, Apoptosis, Lung cancer, Adenocarcinoma, Cancer, Region, Gefitinib, Market access, Deletion, Tobacco smoking, Patient, Internet, Female, Retail

The "EGFR Tests Market Size by Segments, Share, Regulatory, Reimbursement and Forecast to 2033" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "EGFR Tests Market Size by Segments, Share, Regulatory, Reimbursement and Forecast to 2033" report has been added to ResearchAndMarkets.com's offering.
  • The model includes EGFR Immunohistochemistry Tests, EGFR Sanger Sequencing Tests, EGFR Nucleic Acid Amplification Tests (NAATs), and EGFR Other Tests (EGFR ISH and Mass Array tests).
  • Key Inclusions of the market model are:
    Currently marketed EGFR Tests and evolving competitive landscape:
    Insightful review of the key industry trends.
  • Global, Regional and Country level market specific insights:
    Qualitative market specific information is available with global trends further broken down into regional trends.

Ocean Biomedical Announces Newly Published Findings Demonstrating Ability to Restore Treatment Sensitivity to AstraZeneca’s Leading Lung Cancer Drug After Resistance Has Formed, and Enhanced Tumor Suppression in EGFR-Mutation Lung Cancers

Retrieved on: 
Tuesday, October 3, 2023
Yale University, BioRxiv, RI, FRG, Osimertinib, Lung cancer, TUNEL, TKI, Research, Targeted therapy of lung cancer, Cell, Immunotherapy, AstraZeneca, Glioblastoma, Preprint, Gefitinib, Patient, EGFR, Growth, Neoplasm, Salvage therapy, Pharmaceutical industry, Vaccine, Dietary supplement, Medical imaging, Ocean Biomedical, CHI3L1, NSCLC, Cancer

Providence, RI, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today that its cancer-targeting immunotherapy antibody candidate has demonstrated effective tumor reduction against an aggressive subset of Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations. These research findings, which may be the most important Ocean Biomedical has announced to date, generated by Ocean’s Scientific Co-founder Dr. Jack A. Elias and colleagues from Yale University and Brown University, and first published as a preprint last week in bioRxiv, are the first to uncover the role of Chitinase 3-like-1 (CHI3L1) in the pathogenesis of EGFR-mutant cancers, with potential applications not just in NSCLC, but in all EGFR-mutant cancers, including glioblastoma and colon cancer.

Key Points: 
  • Additionally, the findings demonstrate a stunning ability to restore therapeutic sensitivity to current tyrosine kinase inhibitor (TKI) therapies after resistance sets in, including the third-generation TKI, Osimertinib (marketed as Tagrisso by AstraZeneca).
  • In 2022, AstraZeneca’s top pharmaceutical product by revenue was Tagrisso, a medication used in the treatment of non-small-cell lung carcinomas.
  • Non-Small Cell Lung Cancer (NSCLC) is a leading cause of cancer deaths globally, accounting for 85% of all lung cancers.
  • The EGFR-mutant lung cancer is found in 30%-50% of NSCLC patients with Asian heritage and 10%-20% of patients with Caucasian backgrounds.

Datopotamab Deruxtecan Met Dual Primary Endpoint of Progression-Free Survival in Patients With Advanced Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial

Retrieved on: 
Monday, July 3, 2023
Research, Clinical Trials, Cardiology, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, International, Cleavage, World Health Organization, Lead, MD, Patient, Immunoglobulin G, EGFR, Daiichi Sankyo, Spacecraft, ALK, Pharmacotherapy, Pircher, Observational study, Lung cancer, HIV disease progression rates, ADC, Immunology, PD-1, Death, PD-L1, Safety, Docetaxel, Medicine, Treatment of lung cancer, Immunotherapy, PFS, Sapporo Medical University, Gefitinib, Pemetrexed, Triple-negative breast cancer, Metabolism, Progression-free survival, International Agency for Research on Cancer, OS, Biopharmaceutical, AstraZeneca, Lung, Rare, DXD, American Cancer Society, Treatment, Breast cancer, Medical imaging, Pharmaceutical industry, Fine chemical, Nursing, Mineral wool, Cancer, NSCLC

The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.
  • Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
  • Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
  • AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with datopotamab deruxtecan.

Chinese Company Qilu Pharmaceutical Is Supplying the Anti-Cancer Drug Cisplatin Injection to the United States Again

Retrieved on: 
Sunday, July 2, 2023
Injection, Communication, Tablet, Gefitinib, Intelligence, FDA, Cisplatin, Lung cancer, Automation, Sale, Pharmaceutical industry

This is the second batch of drugs supplied by this well-known Chinese pharmaceutical company to the United States, following the first batch of 18000 cisplatin injections exported to the United States.

Key Points: 
  • This is the second batch of drugs supplied by this well-known Chinese pharmaceutical company to the United States, following the first batch of 18000 cisplatin injections exported to the United States.
  • On May 31st Beijing time, Qilu Pharmaceutical Group shipped 18000 bottles of cisplatin injection to the United States without affecting domestic product supply.
  • In addition, the FDA's rapid licensing of Qilu Pharmaceutical's cisplatin injection for export to the United States is related to the company's years of deep cultivation in the world's largest pharmaceutical market - the United States market.
  • With the shipment of cisplatin injection to the United States, this is already the 24th formulation product of Qilu Pharmaceutical Group to achieve commercial sales in the United States.

Scorpion Therapeutics Nominates STX-241 as Potentially Best-in-Class Fourth-Generation EGFR Inhibitor Development Candidate for the Treatment of Non-Small Cell Lung Cancer

Retrieved on: 
Monday, April 3, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Central nervous system, Therapeutic index, Lung cancer, CNS, Gefitinib, Medicine, Patient, EGFR, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, Penetrance, Pharmaceutical industry, Scorpion, NSCLC

STX-241 is the third development candidate nominated by Scorpion in less than three years, and the second highly selective epidermal growth factor receptor (“EGFR”) development candidate from the Company’s franchise of next-generation mutant EGFR inhibitors for the treatment of non-small cell lung cancer (“NSCLC”).

Key Points: 
  • STX-241 is the third development candidate nominated by Scorpion in less than three years, and the second highly selective epidermal growth factor receptor (“EGFR”) development candidate from the Company’s franchise of next-generation mutant EGFR inhibitors for the treatment of non-small cell lung cancer (“NSCLC”).
  • NSCLC is the most common form of lung cancer and EGFR mutations are one of its most common disease drivers.
  • “We are particularly proud to introduce our third internally discovered development candidate in less than three years after the founding of Scorpion.
  • Scorpion is also developing STX-721, a potentially best-in-class exon 20 mutant EGFR inhibitor, for which an IND application is expected in 2023.

Foundation Medicine Receives FDA Approval for FoundationOne®Liquid CDx as a Companion Diagnostic for a Certain Group of Tyrosine Kinase Inhibitors for Treatment of Non-Small Cell Lung Cancer Patients

Retrieved on: 
Wednesday, December 21, 2022
FDA, Health, Oncology, Cancer, Foundation Medicine, Liquid, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Oncology, DNA, Patient, Gefitinib, TKI, FDA, Large-cell lung carcinoma, Neoplasm, Exon, EGFR, Pharmaceutical industry, Medical device, NSCLC

“For NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” says Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine.

Key Points: 
  • “For NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21 substitutions, this approval opens new access avenues for targeted treatment options,” says Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine.
  • “Following three recent group companion diagnostic approvals for Foundation Medicine’s tissue-based test, FoundationOne®CDx, this first group approval for FoundationOne Liquid CDx builds upon the momentum for more efficient and innovative regulatory approaches to the companion diagnostic approval process.
  • The current therapies for which FoundationOne Liquid CDx is a companion diagnostic under the group approvals are Tarceva (erlotinib), Tagrisso (osimertinib) and Iressa (gefitinib).
  • Moving forward, FoundationOne Liquid CDx will automatically become a companion diagnostic for future TKIs within this group for NSCLC that are approved by the FDA.

EQRx Announces Acceptance of Marketing Authorization Application by the European Medicines Agency for Aumolertinib in EGFR-Mutated Non-small Cell Lung Cancer

Retrieved on: 
Friday, December 2, 2022
National Medical Products Administration, NSCLC, Safety, European Medicines Agency, Journal, Gefitinib, NMPA, Progression-free survival, Large-cell lung carcinoma, EGFR, Cancer, Annual report, American Journal of Clinical Oncology, EMA, MD, Patient, Social media, Health care, MAA, TKI, Lung cancer, Treatment of lung cancer, FAQ, Pharmaceutical industry, Greater China

The European Medicines Agency engages with 27 member states to ensure that the needs and concerns of a wide range of patients, including approximately 60,000 European patients who may be diagnosed with EGFR-mutated non-small cell lung cancer annually, are represented.

Key Points: 
  • The European Medicines Agency engages with 27 member states to ensure that the needs and concerns of a wide range of patients, including approximately 60,000 European patients who may be diagnosed with EGFR-mutated non-small cell lung cancer annually, are represented.
  • The MAA is primarily supported by data from the pivotal Phase 3 AENEAS trial evaluating aumolertinib in the first-line treatment of locally advanced or metastatic EGFR-mutated NSCLC.
  • 3
    This is EQRxs second submission to a regulatory agency for aumolertinib.
  • Aumolertinibs MAA for use in EGFR-mutated non-small cell lung cancer is currently under review by the UKs Medicines and Healthcare products Regulatory Agency.

LOTUS REPORTS ITS BEST QUARTER EVER WITH THE BIGGEST LAUNCH IN ITS HISTORY

Retrieved on: 
Friday, November 11, 2022
Asian Business Case Competition @ Nanyang, EPS, Rheumatoid arthritis, Company, LTM, RA, Korean won, Total, Gefitinib, Tadalafil, Growth, Record, Partnership, Enzalutamide, Sunitinib, Pharmaceutical industry, Video game, Drug, Airline, Fine chemical, Renewable energy, Vinorelbine, Lenalidomide, Lotus, Midostaurin

Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.

Key Points: 
  • Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.
  • Consolidated net sales were NT$5,389 million, representing a growth of 85.2% over the last quarter and 76.3% versus prior year period.
  • Sales from Export increased 245% compared to last quarter and 183% compared to same period last year.
  • Asian Business continued to grow for the third consecutive quarter, 3.2% over last quarter, also 10.8% over the same period last year.

LOTUS REPORTS ITS BEST QUARTER EVER WITH THE BIGGEST LAUNCH IN ITS HISTORY

Retrieved on: 
Friday, November 11, 2022
Asian Business Case Competition @ Nanyang, EPS, Rheumatoid arthritis, Company, LTM, RA, Korean won, Total, Gefitinib, Tadalafil, Growth, Record, Partnership, Enzalutamide, Sunitinib, Pharmaceutical industry, Video game, Drug, Airline, Fine chemical, Renewable energy, Vinorelbine, Lenalidomide, Lotus, Midostaurin

Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.

Key Points: 
  • Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.
  • Consolidated net sales were NT$5,389 million, representing a growth of 85.2% over the last quarter and 76.3% versus prior year period.
  • Sales from Export increased 245% compared to last quarter and 183% compared to same period last year.
  • Asian Business continued to grow for the third consecutive quarter, 3.2% over last quarter, also 10.8% over the same period last year.