Entrectinib

Lung Cancer Therapies Market to Amplify Significantly over 2022-2029 - Brandessence Market Research

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Monday, May 29, 2023
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With rapid evolution in the field of medical research, numerous therapies aimed at treating lung cancer have been developed.

Key Points: 
  • With rapid evolution in the field of medical research, numerous therapies aimed at treating lung cancer have been developed.
  • The business intelligence report on Lung Cancer Therapies Market by Brandessence Market Research is curated with an aim to provide the industry participants with a succulent overview of this industry.
  • By treatment, the chemotherapy segment is projected to amass notable gains due to its efficacy in treating lung cancer.
  • The Lung Cancer Therapies Market is anticipated to garner significant returns over the estimated timeline of 2022-2029.

FoundationOne®Liquid CDx Receives FDA Approval as a Companion Diagnostic for Rozlytrek® (entrectinib)

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Wednesday, January 4, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, Health, Pharmaceutical, Science, Oncology, Lung cancer, Cancer, Foundation Medicine, Hoffmann-La Roche, Liquid, Food, CGP, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Genentech, Breast, Patient, FDA, Entrectinib, Cholangiocarcinoma, ROS1, NSCLC, Sarcoma, Pharmaceutical industry, Medical device

FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib).

Key Points: 
  • FoundationOne Liquid CDx is the first and only blood-based companion diagnostic approved for Rozlytrek (entrectinib).
  • This decision from the FDA follows the approval of Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, FoundationOne®CDx, for the same therapy last year.
  • CGP has transformed the traditional ‘one-size fits-all’ approach to cancer and is an important tool for identifying rare and hard to find mutations, including ROS1 and NTRK.
  • Foundation Medicine’s two FDA-approved tests both meet rigorous analytical and clinical validation standards and demonstrate Foundation Medicine’s deep regulatory expertise – FoundationOne Liquid CDx has the broadest gene panel of any FDA-approved blood-based test, and the company’s tissue-based CGP test, FoundationOne CDx, was the first ever FDA-approved broad companion diagnostic test.

Nuvalent Reports Preliminary Phase 1 Clinical Data from ARROS-1 Trial that Support Best-In-Class Potential of NVL-520 for Patients withROS1-Positive NSCLC

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Friday, October 28, 2022
CNS, Drug development, ENA, NASDAQ, Private Securities Litigation Reform Act, Investor, Cancer, U.S. Securities and Exchange Commission, Horizon, Memorial Sloan Kettering Cancer Center, Multimedia, RECIST, NSCLC, MSK, Neoplasm, Population, ALK, Achievement, Nasdaq, HER2, Brain, TKI, Patient, Risk, Research, Twitter, ORR, PRS, Infrared spectroscopy correlation table, History, Pharmacokinetics, Company, Crizotinib, LinkedIn, Safety, Large-cell lung carcinoma, ROS1, Program, Mutation, Clinical trial, Security (finance), Chemistry, Șaeș, Trae Elston, Association, COVID-19, TRK, Dizziness, ID, Caregiver, Entrectinib, Medical device, Pharmaceutical industry, Health insurance, Medical imaging

CAMBRIDGE, Mass., Oct. 28, 2022 /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 initial data from the Phase 1 dose-escalation portion of its ongoing ARROS-1 Phase 1/2 clinical trial of NVL-520 for patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) and other solid tumors. These data will be presented today in the "New Drugs on the Horizon" oral plenary session at the 34th EORTC-NCI-AACR (ENA) Symposium in Barcelona, Spain.

Key Points: 
  • As of September 1, 2022, 35 subjects have been enrolled in the Phase 1 portion of the ARROS-1 trial.
  • Preliminary activity data reported as of the data cut-off date were available from 21 heavily pre-treated response-evaluable NSCLC patients, of which partial responses were observed in 48% (10/21).
  • NVL-520 is currently being evaluated in the ongoing ARROS-1 Phase 1/2 clinical trial, a first-in-human study of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.
  • NVL-520 is currently being investigated in the ARROS-1 trial ( NCT05118789 ), a first-in-human Phase 1/2 clinical trial for patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors.

Nerviano Medical Sciences S.r.l. Announces Collaboration and Option to License Agreement with Merck

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Wednesday, September 21, 2022
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, Control, Breast, NCE, Brain, Hoffmann-La Roche, NMS, TMZ, Neoplasm, Prostate, ADMET, GBM, DNA repair, Achievement, ADP, Pharming, IP, PARP1, Patient, Medicine, Cancer, Exercise, CRO, Global Vision, API, PARP, Drug development, Research, DNA, FIC, Health care, BRCA, Temozolomide, Drug discovery, ROS1, Encorafenib, Pharmaceutical industry, Medical imaging, Fine chemical, Entrectinib, Glioblastoma, Merck

NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors.

Key Points: 
  • NMS-293 is an orally available PARP1 inhibitor, designed to be more PARP1 selective and brain penetrant compared to first generation PARP inhibitors.
  • Under the current agreement, Merck will make early payments (up-front and option exercise fees) of up to US$65 million to NMS.
  • Furthermore, NMS will receive payments for the achievement of certain development, regulatory and commercial milestones and tiered royalties on net sales by Merck.
  • Upon exercise of the option, NMS will grant to Merck the exclusive rights to research, develop, manufacture, and commercialize NMS-293.

AUM Biosciences Receives FDA Orphan Drug Designation for AUM601 for the Treatment of Solid Tumors with the NTRK Fusion Gene

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Thursday, August 18, 2022
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We are thrilled to have received our first Orphan Drug Designation just months after presenting our results from the Phase 1 study of AUM601, said Vishal Doshi, CEO of AUM Biosciences.

Key Points: 
  • We are thrilled to have received our first Orphan Drug Designation just months after presenting our results from the Phase 1 study of AUM601, said Vishal Doshi, CEO of AUM Biosciences.
  • This decision from the FDA, in addition to our existing clinical evidence, further strengthens our ambition to bring a differentiated and improved treatment option for solid tumors with the NTRK Fusion Gene.
  • We look forward to beginning the phase 2 trial soon and providing additional insight into its indisputable advantage over current treatment options.
  • AUM601 has 22x higher concentration of drug in tumors as compared to plasma as well as higher tumor exposure in vivo.

U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for Rozlytrek® (entrectinib)

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Thursday, June 9, 2022
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Were proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine.

Key Points: 
  • Were proud that this companion diagnostic will enable broader access to genomic testing and this breakthrough therapy, ultimately allowing more patients to benefit from precision medicine.
  • The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicines deep regulatory expertise.
  • FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).
  • For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx .

Data at the 2022 ASCO Annual Meeting Highlight Genentech’s Continued Commitment to Innovation in Oncology and Personalized Healthcare

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Tuesday, May 24, 2022
Biotechnology, Pharmaceutical, Health, Oncology, Bone, Hyperuricemia, Death, Risk, ROS1, Pain, Nausea, Blood, Entrectinib, Dizziness, TRK, Liver disease, Disease, Severe cognitive impairment, Confusion, Liver, Symptoms of COVID-19, Memory, Patient, Fusion, QT, Adult, Health care, Hallucination, Uric acid, NSCLC, FDA, CNS, Heart, Electrolyte, Oral medicine, Heart failure, Genentech, Fertility, Vomiting, Attention, Mutation, Movement, Hepatotoxicity, Cancer, Central nervous system, Sleep, Birth control, Vaccine, Pharmaceutical industry, Dentistry, Atezolizumab

Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

Key Points: 
  • Patients should ask their healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.
  • A healthcare provider may temporarily stop treatment, decrease the dose, or permanently stop Rozlytrek if a patient develops liver problems with Rozlytrek.
  • Healthcare providers may stop Rozlytrek and refer to an eye specialist if a patient develops severe vision problems during treatment with Rozlytrek.
  • Patients should tell their healthcare provider right away if they have any loss of vision or any change in vision, including:

AnHeart Therapeutics Announces Presentation at the European Lung Cancer Congress (ELCC) 2022

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Monday, March 21, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Company, Cancer, Therapy, Pemetrexed, Crizotinib, EML4-ALK positive lung cancer, Entrectinib, Traffic barrier, Clinical trial, RECIST, ORR, TKI, University of California, School, University of California, Irvine, Program, Colorectal cancer, Platinum, Medical school, AXL, NSCLC, Poster, Korea, CEO, PFS, Safety, IRC, ROS1, UC, Lung cancer, University, Patient, Lung, Pharmaceutical industry, Glioblastoma, Cholangiocarcinoma, TRUST-II STUDY, TALETRECTINIB, ANHEART THERAPEUTICS, TRUST-II STUDY, TALETRECTINIB, ANHEART THERAPEUTICS

AnHeart Therapeutics (AnHeart), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, today announced a poster presentation for ROS1 inhibitor taletrectinib at the European Lung Cancer Congress 2022, held in Prague, Czech Republic, and virtually, March 30-April 2, 2022.

Key Points: 
  • AnHeart Therapeutics (AnHeart), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, today announced a poster presentation for ROS1 inhibitor taletrectinib at the European Lung Cancer Congress 2022, held in Prague, Czech Republic, and virtually, March 30-April 2, 2022.
  • Details of the poster presentation are below:
    Poster Presentation Title: TRUST-II: A Global Phase II Study for Taletrectinib in ROS1 fusion Positive Lung Cancer and other solid tumors.
  • Date/Time: The e-Posters will be available on the virtual platform of the ELCC website, in the e-Posters section, as of 29 March at 12:00 CEST.
  • AnHeart Therapeutics (AnHeart), a Cayman Islands entity (registered name AnBio Therapeutics Ltd.), is a clinical-stage global biopharmaceutical group company developing a broad pipeline of novel or next-generation precision oncology therapeutics with high unmet medical needs.

Notice Concerning Application for Partial Revision of Manufacturing and Marketing Approval of Companion Diagnostic Reagent for the AmoyDx® Pan Lung Cancer PCR Panel

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Wednesday, February 23, 2022
GLOBE, PCR, EGFR, Crizotinib, Growth, Chemotherapy, Gene, Polymerase chain reaction, ALK, BRAF, TRK, Mutation, Precision medicine, ROS1, Marketing, Patient, Technology, Organic acid, Partial, MET, Vaccine, NSCLC, Entrectinib

“We are pleased to announce this application. We look forward to getting marketing approval in order to help expand access to timely therapy options for Japanese patients,” stated representatives of the three companies -- Kenji Iwakabe, President and Chief Executive Officer of Riken Genesis, Li-Mou Zheng, Ph.D., Founder and Chief Executive Officer of AmoyDx and Wenn Sun, Ph.D., Founder and President of PREMIA.

Key Points: 
  • The AmoyDx PLC Panel has received approval for five driver genes (EGFR, ALK, ROS1, BRAF, and MET exon 14 skipping), for ten associated, targeted therapies in NSCLC.
  • When ROS1 fusion genes are detected by the AmoyDx PLC Panel, it helps to determine the therapeutic indication for Crizotinib in patients with ROS1 fusion gene-positive NSCLC.
  • If the AmoyDx PLC Panel is approved for Entrectinib, it is expected to contribute to expanding treatment opportunities for patients with ROS1 fusion-positive NSCLC.
  • By inhibiting ROS1 and TRK kinase activity, Rozlytrek inhibits the growth of cancer cells with ROS1 or NTRK fusion genes.

Erasca Strengthens Leadership Team with Two Key Executive Appointments

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Tuesday, January 18, 2022
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SAN DIEGO, Jan. 18, 2022 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced the appointment of Lisa Tesvich-Bonora as Chief People Officer and the promotion of Robert Shoemaker to Senior Vice President of Research.

Key Points: 
  • Dr. Lim continued, I am also very pleased to announce Roberts promotion to Senior Vice President of Research.
  • Dr. Tesvich-Bonora brings more than 20 years of experience as a strategic leadership consultant, with expertise in organizational development, culture, and talent management.
  • Prior to joining Erasca, she was founder and president of Inspire True Leadership, an organizational advisory company focused on enabling business growth through leadership excellence and a strong people agenda.
  • Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements.