Tyrosine kinase inhibitors

Oncternal Therapeutics Announces Presentation of Interim Phase 1/2 Data Update for Cirmtuzumab in Combination with Ibrutinib at ASH 2020 Virtual Annual Meeting

Retrieved on: 
Monday, December 7, 2020
Health sciences, Health, Orphan drugs, Chemical compounds, Breakthrough therapy, Tyrosine kinase inhibitors, Acrylamides, Ibrutinib, Pyrazolopyrimidines, Clinical trial

The data were presented at the American Society of Hematology (ASH) 2020 Virtual Annual Meeting, and a copy of the poster presentation is available online at www.oncternal.com :

Key Points: 
  • The data were presented at the American Society of Hematology (ASH) 2020 Virtual Annual Meeting, and a copy of the poster presentation is available online at www.oncternal.com :
    Session Title: 623.
  • We are in active dialogue with FDA on pivotal study design in order to define the path to approval in MCL.
  • The combination of cirmtuzumab plus ibrutinib has been well tolerated, with adverse events consistent with those reported for ibrutinib alone.
  • The CIRLL clinical trial (CIRM-0001) is a Phase 1/2 trial evaluating cirmtuzumab in combination with ibrutinib in separate groups of patients with CLL or MCL.

New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukemia

Retrieved on: 
Sunday, December 6, 2020
Chemical compounds, Organic compounds, Tyrosine kinase inhibitors, Tyrosine kinases, Acrylamides, Breakthrough therapy, Ibrutinib, Pyrazolopyrimidines, Bruton's tyrosine kinase, Branches of biology, Leukemia

Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Key Points: 
  • Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Manage cardiac arrhythmias appropriately, and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.
  • Monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust anti-hypertensive medication throughout treatment with IMBRUVICA as appropriate.
  • The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia.

New Data Demonstrate Long-Term Benefit of IMBRUVICA® (ibrutinib) as First-Line Treatment for High-Risk Chronic Lymphocytic Leukaemia

Retrieved on: 
Sunday, December 6, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, RTT, Breakthrough therapy, Chemical compounds, Cancer, Organic compounds, Tyrosine kinase inhibitors, Genentech, Hoffmann-La Roche, Obinutuzumab, Chronic lymphocytic leukemia, Ibrutinib, SLL

Janssen Biotech, Inc.; Janssen-Cilag Ltd., Middle East; and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen Biotech, Inc.; Janssen-Cilag Ltd., Middle East; and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • Real-world prognostic biomarker testing, treatment patterns and dosing among 1461 patients (pts) with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) from the informCLL prospective observational registry.
  • Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial.
  • Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

CALQUENCE Shows Long-Term Efficacy and Tolerability at Three Years for Patients With Relapsed or Refractory Mantle Cell Lymphoma

Retrieved on: 
Monday, December 7, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Branches of biology, Cancer, Tyrosine kinases, Clinical medicine, Tyrosine kinase inhibitors, Mantle cell lymphoma, Non-Hodgkin lymphoma, Bruton's tyrosine kinase, Acalabrutinib, Entospletinib, Lenalidomide, Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer treatments, Branches of biology, Tyrosine kinase inhibitors, Orphan drugs, Tyrosine kinases, Clinical medicine, Mantle cell lymphoma, Non-Hodgkin lymphoma, Bruton's tyrosine kinase, Acalabrutinib, Entospletinib

CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Key Points: 
  • CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
  • Fatal and serious hemorrhagic events have occurred in patients with hematologic malignancies treated with CALQUENCE.
  • In clinical trials, major hemorrhage occurred in 2.7% of patients taking CALQUENCE without antithrombotic agents and 3.6% of patients taking CALQUENCE with antithrombotic agents.
  • Acalabrutinib Monotherapy in Patients With Relapsed/Refractory Mantle Cell Lymphoma: Long-Term Efficacy and Safety Results From a Phase 2 Study.

Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukaemia

Retrieved on: 
Saturday, December 5, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Chemical compounds, Organic compounds, Breakthrough therapy, Drugs, Orphan drugs, Antineoplastic drugs, Tyrosine kinase inhibitors, Chloroarenes, Venetoclax, Ibrutinib, Chronic lymphocytic leukemia, Obinutuzumab

Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study.

Key Points: 
  • Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study.
  • Ibrutinib (Ibr) Plus Venetoclax (Ven) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL): 1-Year Disease-Free Survival (DFS) Results From the MRD Cohort of the Phase 2 CAPTIVATE Study.
  • A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).
  • Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.

New Data for TecartusTM Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma

Retrieved on: 
Saturday, December 5, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical trials, Clinical medicine, Medicine, Orphan drugs, Drugs, Breakthrough therapy, Tyrosine kinase inhibitors, Antineoplastic drugs, Gene therapy, Chronic lymphocytic leukemia, Brexucabtagene autoleucel, Lymphoid leukemia, Leukemia

In July, Tecartus became the first CAR T-cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response.

Key Points: 
  • In July, Tecartus became the first CAR T-cell therapy to receive accelerated approval from the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on overall response rate and durability of response.
  • In addition to MCL, Tecartus is also currently in Phase 1/2 trials in acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL).
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution.

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Thursday, December 3, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Organic compounds, Chemical compounds, Quinazolines, Cancer, Tyrosine kinase inhibitors, Epidermal growth factor receptor, Oncogenes, Non-small-cell lung carcinoma, Lung cancer, T790M, KRAS, Amivantamab, the Amivantamab Expanded Access Program Protocol (EAP), Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson

Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab.

Key Points: 
  • Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab.
  • 7 Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer.
  • 14 Chen D, Song Z, Cheng G. Clinical efficacy of first-generation EGFRTKIs in patients with advanced nonsmallcell lung cancer harboring EGFR exon 20 mutations.
  • Real-World Treatment Patterns and Survival in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations.

Puma Biotechnology, Inc. Prevails Before European Patent Office Board of Appeals in Decision Upholding European Patent (EP 1848414) as Granted

Retrieved on: 
Wednesday, December 2, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Organic compounds, Chemical compounds, Quinazolines, Amines, Aromatic compounds, Chloroarenes, Tyrosine kinase inhibitors, Erlotinib, Ethers, T790M, Gefitinib, Epidermal growth factor receptor

The European Board of Appeals announced its decision at a hearing on December 1st, rejecting the opposition of EP Patent 1848414 initiated by a Boehringer Ingelheim entity.

Key Points: 
  • The European Board of Appeals announced its decision at a hearing on December 1st, rejecting the opposition of EP Patent 1848414 initiated by a Boehringer Ingelheim entity.
  • The EP Patent 1848414 originally granted in April 2011 covers the use of irreversible EGFR inhibitors in treating gefitinib and/or erlotinib resistant cancer and cancer with a T790M EGFR mutation.
  • On November 28, 2011, an opposition was filed seeking invalidation of the patent.
  • At a final hearing, the Board of Appeals announced its decision, concluding that the opposition was inadmissible and reversing the European Opposition Division decision issued in 2014, thereby upholding the EP Patent 1848414 as originally granted.

TG Therapeutics Announces Publication of Phase 2 Data Evaluating Umbralisib in Patients with Chronic Lymphocytic Leukemia Who Are Intolerant to Prior BTK or PI3K Inhibitor Therapy in Blood

Retrieved on: 
Wednesday, December 2, 2020
Cancer, Clinical medicine, Medicine, Drug discovery, Phosphoinositide 3-kinase inhibitor, Orphan drugs, Tyrosine kinases, Oncology, Tyrosine kinase inhibitors, Umbralisib, Bruton's tyrosine kinase, Chronic lymphocytic leukemia

The manuscript includes data from 51 chronic lymphocytic leukemia (CLL) patients who were previously treated with and became intolerant to prior BTK or PI3K inhibitor therapy (44 BTK intolerant and 7 PI3K intolerant patients).

Key Points: 
  • The manuscript includes data from 51 chronic lymphocytic leukemia (CLL) patients who were previously treated with and became intolerant to prior BTK or PI3K inhibitor therapy (44 BTK intolerant and 7 PI3K intolerant patients).
  • Eight patients (16%) had dose reductions and were successfully rechallenged allowing them to continue on umbralisib.
  • As of the data cut off, 58% of patients had been on umbralisib for a longer duration than their prior kinase inhibitor.
  • The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia

Retrieved on: 
Tuesday, December 1, 2020
Drugs, Clinical medicine, Cancer treatments, Orphan drugs, Chronic lymphocytic leukemia, Breakthrough therapy, Umbralisib, Tyrosine kinase inhibitors, Antineoplastic drugs, Monoclonal antibodies, Phosphoinositide 3-kinase inhibitor, P110δ

Food and Drug Administration(FDA) requesting approval of ublituximab, the Companys investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Companys investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL).

Key Points: 
  • Food and Drug Administration(FDA) requesting approval of ublituximab, the Companys investigational glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib, the Companys investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL).
  • FDA previously granted Fast Track Designation to the combination of ublituximab and umbralisib (U2) for the treatment of adult patients with CLL and Orphan Drug Designation (ODD) covering ublituximab in combination with umbralisib for the treatment of CLL.
  • The Company expects to complete the BLA rolling submission in the first half of 2021.
  • We believe, if approved, U2 has the potential to become an important treatment option to both front line and relapsed/refractory patients with CLL.