TKI

Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520

Retrieved on: 
Tuesday, February 27, 2024
NSCLC, BTD, ROS1, FDA, Food, TRK, Brain, CNS, Patient, Diagnosis, TKI, Cancer

There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs.

Key Points: 
  • There remains no clear standard of care for patients who have been previously treated with two or more ROS1 TKIs.
  • "We're very encouraged by today's announcement of FDA breakthrough therapy designation for NVL-520, as it recognizes the continued need for innovation for patients with ROS1-positive NSCLC who have exhausted available therapies.
  • We look forward to providing an update from the ARROS-1 trial of NVL-520 at a medical meeting later this year."
  • Under the designation, the FDA provides intensive guidance, organizational commitment involving senior managers, and eligibility for rolling review and other actions to expedite review.

Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Retrieved on: 
Wednesday, February 14, 2024
CHB, BCR-ABL, FDA, Food, Hepatitis, Safety, Bone marrow, NCCN, Patient, Notifiable disease, National Comprehensive Cancer Network, Mutation, CML, TKI, Cancer, Pharmaceutical industry

Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.

Key Points: 
  • Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.
  • The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma.
  • *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

AVEO Oncology Announces Publication of Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial in The Oncologist

Retrieved on: 
Tuesday, February 6, 2024
OS, Vanderbilt-Ingram Cancer Center, VEGFR, Survival, IO, TKI, Renal cell carcinoma, Division, RCC, MD, PFS, Safety, Patient, Progression-free survival, Sorafenib, Arm, Disease, ITT, Assistant, Oncology, LG Chem, Doctor of Philosophy, Pharmaceutical industry

The trial included a predefined subgroup of patients (26%) who were previously treated with both an immuno-oncology (IO) therapy and a VEGFR TKI.

Key Points: 
  • The trial included a predefined subgroup of patients (26%) who were previously treated with both an immuno-oncology (IO) therapy and a VEGFR TKI.
  • “For patients with relapsed or refractory advanced renal cell carcinoma, long-term progression-free survival is a vital measure of the value of anticancer therapy,” commented Michael Bailey, President and CEO of AVEO Oncology.
  • The trial randomized 350 patients to receive FOTIVDA (1.5 mg once daily) or sorafenib (400 mg twice daily).
  • The intent-to-treat (ITT) population included 175 patients in each arm; the safety population included 173 patients in the FOTIVDA arm and 170 in the sorafenib arm.

Elevar Therapeutics To Present Two Posters From Phase 3 CARES-310 Study at 2024 ASCO Gastrointestinal Cancers Symposium

Retrieved on: 
Thursday, January 18, 2024
CP, Patient, Therapy, Sorafenib, PD-1, ASCO, Survival, Society, Camrelizumab, Quality of life, Hepatocellular carcinoma, Food, DIH, Hepatotoxicity, FDA, PDUFA, TKI, Moscone Center

ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.

Key Points: 
  • ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online.
  • Elevar’s poster presentations are:
    Abstract Title: Impact of baseline liver function on survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC) treated with camrelizumab + rivoceranib vs sorafenib: A post hoc analysis of study CARES-310.
  • The results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients.
  • The FDA assigned Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

Retrieved on: 
Tuesday, January 16, 2024
MSD, PRISM, Renal cell carcinoma, Hypoxia, Patient, HCC, Research, Neoplasm, Meta-analysis, Oxidative stress, Rescue coordination centre, RCC, Merck & Co., ASCO, Cell lineage, Everolimus, Society, Pembrolizumab, Headquarters, FGFR2, Deep, Cholangiocarcinoma, Drug discovery, Hepatocellular carcinoma, Cancer, Food, Proteostasis, CBP, Safety, Abstract, Food and Drug Administration, FDA, Inflammation, CREB-binding protein, Biomarker, LEAP, TKI, Merck, Differentiable function, Pharmaceutical industry

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

Eisai Furthers Oncology Research in Gastrointestinal Cancer Treatment with New Data at ASCO GI 2024

Retrieved on: 
Tuesday, January 16, 2024
Senior, Patient, HCC, Research, Neoplasm, ASCO, Society, Liver cancer, FGFR2, Hepatocellular carcinoma, Apoptosis, CBP, Safety, Abstract, FDA, Gastrointestinal cancer, CREB-binding protein, Biomarker, Merck, LEAP, TKI, Pharmaceutical industry

NUTLEY, N.J., Jan. 16, 2024 /PRNewswire/ -- Eisai announced today the presentation of gastrointestinal cancer research during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place in-person in San Francisco, California and virtually from January 18-20.

Key Points: 
  • "We look forward to convening in San Francisco to share longer-term efficacy and safety results from the Phase 3 LEAP-002 trial with the scientific community at ASCO GI 2024.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective TKI of FGFR1-3.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • These abstracts will be made available via the ASCO website on Tuesday, January 16, 2024, at 5:00 PM EST (2:00 PM PST).

Zai Lab Announces The New England Journal of Medicine Publication Demonstrating Durable Clinical Activity of Repotrectinib in Patients with Advanced ROS1 Fusion-Positive NSCLC

Retrieved on: 
Wednesday, January 10, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Development, Patient, Therapy, Progression-free survival, ROS1, Brain, Index, HKEX, Lung cancer, NSCLC, RECIST, Cancer, Food, PFS, NDA, Safety, NEJM, New Drug Application, TKI, CDE, National Medical Products Administration, MTD, NMPA, Pharmaceutical industry

Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.

Key Points: 
  • Repotrectinib is a tyrosine kinase inhibitor (TKI) that has shown robust anti-tumor activity against ROS1+ cancers in preclinical models.
  • In the TRIDENT-1 study, repotrectinib demonstrated high response rates and durable activity in patients with ROS1+ NSCLC, including patients with TKI-naïve and TKI-pretreated tumors, ROS1 G2032R resistance mutations and brain metastases.
  • Brain metastases are common among patients with ROS1+ NSCLC and intracranial activity of approved ROS1 TKIs can be suboptimal.
  • In November 2023, the U.S. Food and Drug Administration approved repotrectinib for use in adult patients with locally advanced or metastatic ROS1+ NSCLC in the United States.

KeifeRx Expands Exclusive Licensing Agreement with Georgetown University to Include Multiple Disease Indications for Portfolio of Novel Tyrosine Kinase Inhibitors

Retrieved on: 
Monday, January 8, 2024
Alzheimer's disease, IND, Georgetown University, Autophagy, B cell, Mast cell activation syndrome, Brain, NCE, TKI, MCAS, MBBS, Growth, ALS

WASHINGTON, Jan. 8, 2024 /PRNewswire/ -- KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

Key Points: 
  • The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases.
  • KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.
  • "We look forward to working with the research team at Georgetown University to spearhead the development of KFRX03, KFRX04, KFRX05, and KFRX06 for the treatment of multiple, underserved disease indications.
  • The IP covering these assets extends through 2037, making the portfolio a high-value drug opportunity given its numerous potential disease indications, including Alzheimer's disease, ALS, mast cell activation syndrome (MCAS), and urticaria."

Exelixis Announces Preliminary Fiscal Year 2023 Financial Results, Provides 2024 Financial Guidance, and Outlines Key Priorities and Milestones for 2024

Retrieved on: 
Sunday, January 7, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Associate, Baylor College of Medicine, PKMYT1, BRCA, FDA, Breast, Progression-free survival, Society, Insilico Medicine, Cancer, Distinguishing, Translational research, Neck, PLK4, Workforce, Conference, Translation, Biology, IND, Colorectal cancer, MSN, NHT, University, PARP, Doctor of Philosophy, Calendar, District court, Harvard University, Immunotherapy, Food, Johnson & Johnson, NET, Huntsman Corporation, Cell adhesion, Therapy, TKI, USP1, Neoplasm, Experiment, Patient, NCI, Corporation, Baylor University, Huntsman Cancer Institute, Research, Acquisition, Dean (education), Education, Pnet, Head, Shareholder, Share repurchase, PFS, ADC, Pharmaceutical industry

The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.

Key Points: 
  • The preliminary 2023 financial information presented in this press release has not been audited and is subject to change.
  • The complete Exelixis Fourth Quarter and Fiscal Year 2023 Financial Results are planned for release after market on Tuesday, February 6, 2024.
  • Exelixis expects to substantially complete the restructuring in the first quarter of 2024 and recognize a restructuring charge of approximately $25 million.
  • In 2024, the company expects to designate two new programs to DC status, including a small molecule PLK4 inhibitor and an additional ADC.

SHIH TZU "COMET" WINS BEST IN SHOW AT 23rd AKC® NATIONAL CHAMPIONSHIP PRESENTED BY ROYAL CANIN

Retrieved on: 
Tuesday, January 2, 2024
Carbon, Boxer, Okie, National championship, Dera, Health, RNC, Dot, Legend, Dog, Luke, CGC, PDS, Whippet, Ashes, Crusader, Royal Canin, German Shepherd, Border Collie, Bolt (2008 film), Bulldog, ABC, Cavalier, Bedlington Terrier, Excellent, Scarlet, Venture, NOHS, Breed, Southpaw, Open, Throne, TKI, MFG, Norwegian Buhund, CDX, Television, Orange County Convention Center, Poodle, Lexi, Onyx, FITB, Magic, AKC, Shetland Sheepdog, Golden, Pot, Temperament, MD, High Times, Best in Show, MJC, Isle of Skye

ORLANDO, Fla., Jan. 2, 2024 /PRNewswire/ -- GCHP CH Hallmark Jolei Out Of This World, a Shih Tzu known as "Comet" triumphed over more than 5,700 competitors to earn a $50,000 cash prize and the title of Best in Show at the AKC® National Championship Presented by Royal Canin, held December 16-17, 2023 at the Orange County Convention Center in Orlando, FL. "Comet," owned by Bonnie J Miller, Susan Carter, Luke & Diane Ehricht of Monclova, OH and bred by Luke & Diane Ehricht, was crowned "America's National Champion" by Best in Show judge Mr. Clay Coady after a weekend of intense canine competition. The winner is America's only National Champion.

Key Points: 
  • CH Von Hawes Forever Forward, a Rottweiler known as "Granger," owned and bred by Peter Hawes & Kathleen Hawes & Erin Maureen Foreman of New Castle, CA.
  • The 2023 AKC® Obedience Classic and the AKC® Agility Invitational presented by YuMOVE were held in conjunction with the AKC® National Championship.
  • Luke and Diane Ehricht were presented with the 2023 AKC Breeder of the Year Award for Hallmark Jolei Shih Tzu at the AKC National Championship on Saturday, December 16, 2023.
  • Click here to download images and video from the AKC National Championship.