Protein kinase inhibitor

FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

Retrieved on: 
Friday, May 15, 2020

SILVER SPRING, Md., May 15, 2020 /PRNewswire/ --Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.

Key Points: 
  • SILVER SPRING, Md., May 15, 2020 /PRNewswire/ --Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract.
  • Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib.
  • GISTs arise when abnormal cells form in the tissues of the gastrointestinal tract.
  • GISTs most commonly occur in the stomach, small intestine, and large intestine but can start anywhere along the gastrointestinal tract.

Tiziana Lifesciences Announces Online Publication of Two Abstracts at the American Society of Clinical Oncology (ASCO) Reporting Clinical Activity and Safety of Milciclib in Patients with Advanced Hepatocellular Carcinoma

Retrieved on: 
Thursday, May 14, 2020

Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.

Key Points: 
  • Abstract #298561: Phase 2a Safety and Efficacy of Milciclib, a Pan-Cyclin Dependent Kinase Inhibitor, in Unresectable, Sorafenib-Refractory or -Intolerant Hepatocellular Carcinoma Patients.
  • Positive demonstrated clinical activity included:
    50% (14 out of 28) evaluable patients completed 6-month duration of the trial.
  • Abstract #307309: Safety and Clinical Activity of Combination Treatment with Regorafenib and Milciclib in Liver Transplant Patients with Hepatocellular Carcinoma Recurrence.
  • The American Society of Clinical Oncology (ASCO) was established in 1964 with the sole purpose of improving the care of people with cancer.

Aptose to Present Early CG-806 Clinical Findings at the 25th Congress of the European Hematology Association

Retrieved on: 
Thursday, May 14, 2020

The accepted abstract is available online on the EHA conference website, ehaweb.org .

Key Points: 
  • The accepted abstract is available online on the EHA conference website, ehaweb.org .
  • CG-806 is an oral, first-in-class FLT3/BTK cluster selective kinase inhibitor and is in Phase 1 clinical studies for the treatment of hematologic malignancies.
  • Because CG-806 targets key kinases/pathways operative in malignancies derived from the bone marrow, it is in development for B-cell cancers and AML.
  • Aptose Biosciences is a clinical-stage biotechnology company committed to developing personalized therapies addressing unmet medical needs in oncology, with an initial focus on hematology.

Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib (TAK-788) for the Treatment of NSCLC Patients with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Monday, April 27, 2020

Mobocertinib is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.

Key Points: 
  • Mobocertinib is a small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target EGFR and human EGFR 2 (HER2) exon 20 insertion mutations.
  • Mobocertinib is a potent, small-molecule TKI specifically designed to selectively target EGFR and HER2 exon 20 insertion mutations.
  • In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including exon 20 insertion mutations.
  • Phase 2 J-EXCLAIM, open-label, multicenter, study evaluating the efficacy of mobocertinib as a first-line treatment in Japanese patients with locally advanced or metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.

Verastem Oncology Announces Investor Conference Call to Discuss Clinical Data from Investigator-initiated RAF/MEK and FAK Combination Study in KRAS Mutant Solid Tumors

Retrieved on: 
Monday, April 20, 2020

The conference call coincides with the presentation of this data at the upcoming American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

Key Points: 
  • The conference call coincides with the presentation of this data at the upcoming American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.
  • Expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  • The combination of VS-6766 and the focal adhesion kinase (FAK) inhibitor defactinib is currently being investigated in a Phase 1 dose escalation and expansion study.
  • Phase 2 study of the focal adhesion kinase inhibitor defactinib (VS-6063) in previously treated advanced KRAS mutant non-small cell lung cancer.

Clinical Cancer Research Highlights Potent Antitumor Activity of Repotrectinib in Treatment-Naïve and Solvent-Front Mutation Ros1-Positive Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, April 16, 2020

Among the findings published in the American Association of Cancer Research peer-reviewed journal, Clinical Cancer Research, repotrectinib demonstrated potent in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors (TKIs) against ROS1 and the ROS1 G2032R solvent-front mutation.

Key Points: 
  • Among the findings published in the American Association of Cancer Research peer-reviewed journal, Clinical Cancer Research, repotrectinib demonstrated potent in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors (TKIs) against ROS1 and the ROS1 G2032R solvent-front mutation.
  • Compared to a lorlatinib proxy chemical compound in a xenograft model, repotrectinib markedly delayed the onset of tumor recurrence following drug withdrawal.
  • Repotrectinib also showed selective and potent in vitro and in vivo activity against the ROS1 G2032R solvent-front mutation.
  • More information about the ongoing TRIDENT-1 study of repotrectinib may be found by searching clinical trial identifier NCT03093116 at https://clinicaltrials.gov.

Verastem Oncology Announces Presentation of Clinical Data from Investigator-initiated RAF/MEK and FAK Combination Study in KRAS Mutant Solid Tumors at the American Association for Cancer Research 2020 Virtual Annual Meeting I

Retrieved on: 
Monday, April 13, 2020

The expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).

Key Points: 
  • The expansion cohorts are currently ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
  • Following the virtual data presentation, Verastem Oncology will host an investor conference call to discuss the presented data.
  • The Company has received Orphan Drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia.
  • Phase 2 study of the focal adhesion kinase inhibitor defactinib (VS-6063) in previously treated advanced KRAS mutant non-small cell lung cancer.

Veracyte Announces Novel Gene Fusion Detection with the Afirma Xpression Atlas, Which May Inform Targeted Treatment Decisions for Thyroid Cancer Patients

Retrieved on: 
Wednesday, April 1, 2020

These gene fusions 70 of which are previously unreported may potentially be targeted with specific kinase inhibitor drugs that are currently available or in development for use in thyroid cancer patients.

Key Points: 
  • These gene fusions 70 of which are previously unreported may potentially be targeted with specific kinase inhibitor drugs that are currently available or in development for use in thyroid cancer patients.
  • The Afirma Genomic Sequencing Classifier (GSC) and Xpression Atlas provide physicians with a comprehensive solution for thyroid nodule diagnosis.
  • Since its founding in 2008, Veracyte has commercialized seven genomic tests and is transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis.
  • Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, and the Veracyte logo are trademarks of Veracyte, Inc. Other trademarks are the property of their respective owners.

AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma

Retrieved on: 
Tuesday, March 31, 2020

AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib, the Companys vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).

Key Points: 
  • AVEO Oncology (NASDAQ: AVEO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tivozanib, the Companys vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed or refractory renal cell carcinoma (RCC).
  • All of us at AVEO offer our continued gratitude to the patients, caregivers, and investigators who participated in our clinical trials.
  • The NDA submission is based on the pivotal active comparator-controlled Phase 3 study, TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC patients.
  • AVEO is working to develop and commercialize tivozanib in North America as a treatment for renal cell carcinoma, hepatocellular carcinoma and other cancers.

Bruton's Tyrosine Kinase (BTK) Inhibitors: Competitive Landscape, Global Markets and Pipeline Analysis (2020-2030)

Retrieved on: 
Monday, March 16, 2020

DUBLIN, March 16, 2020 /PRNewswire/ -- The "Bruton's Tyrosine Kinase (BTK) Inhibitors - Competitive Landscape, Market and Pipeline Analysis, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, March 16, 2020 /PRNewswire/ -- The "Bruton's Tyrosine Kinase (BTK) Inhibitors - Competitive Landscape, Market and Pipeline Analysis, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The report provides the understanding of the unmet needs, market drivers and barriers of the Bruton's Tyrosine Kinase Inhibitors market.
  • Future competitive landscape of Bruton's Tyrosine Kinase (BTK) Inhibitors is estimated to be very strong.
  • Analysis of the current and future market competition in the global Bruton's Tyrosine Kinase Inhibitors market.