Lorlatinib

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Retrieved on: 
Tuesday, March 9, 2021
Chemical compounds, Chemistry, Organic compounds, Piperidines, Breakthrough therapy, Protein kinase inhibitors, Ceritinib, Tyrosine kinase receptors, Crizotinib, Alectinib, Anaplastic lymphoma kinase, Lorlatinib

The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

Key Points: 
  • The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
  • "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy.
  • The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) and LORBRENA (lorlatinib).
  • It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) or LORBRENA (lorlatinib) in the US.

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)

Retrieved on: 
Tuesday, March 9, 2021
Chemical compounds, Chemistry, Organic compounds, Piperidines, Breakthrough therapy, Protein kinase inhibitors, Ceritinib, Tyrosine kinase receptors, Crizotinib, Alectinib, Anaplastic lymphoma kinase, Lorlatinib

The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.

Key Points: 
  • The VENTANA ALK (D5F3) CDx Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for LORBRENA.
  • "It is essential that we identify patients with this cancer biomarker quickly and accurately so they can be treated with effective targeted therapy.
  • The VENTANA ALK (D5F3) CDx Assay is now FDA approved as a companion diagnostic in four targeted treatments - XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) and LORBRENA (lorlatinib).
  • It is indicated as an aid in identifying patients eligible for treatment with XALKORI (crizotinib), ZYKADIA (ceritinib), ALECENSA (alectinib) or LORBRENA (lorlatinib) in the US.

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

Retrieved on: 
Thursday, March 4, 2021
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Chemical compounds, Drugs, Orphan drugs, Breakthrough therapy, Lung cancer, Clinical medicine, Tyrosine kinase receptors, Anaplastic lymphoma kinase, Non-small-cell lung carcinoma, Lorlatinib, Treatment of lung cancer, Ceritinib, the CROWN Trial, Non-Small Cell Lung Cancer (NSCLC), LORBRENA® (lorlatinib), Pfizer Oncology, Pfizer: Breakthroughs That Change Patients’ Lives

LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Key Points: 
  • LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
  • AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively.
  • Based on the CROWN data, the FDA has also converted the accelerated approval to full approval.
  • LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

First Patients Tested with InVisionFirst®-Lung in EORTC Sponsored Phase II NSCLC Study

Retrieved on: 
Wednesday, January 20, 2021
Chemical compounds, Tyrosine kinase receptors, Orphan drugs, Lung cancer, Organic compounds, Lactams, Lorlatinib, Pyridines, Anaplastic lymphoma kinase, European Organisation for Research and Treatment of Cancer, Non-small-cell lung carcinoma, ALK inhibitor

The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.

Key Points: 
  • The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.
  • While in the past these patients were known to respond well to ALK inhibition therapies, such as lorlatinib, drug resistance in patients has been increasing.
  • A total of 100 patients will be involved in two study designs run in parallel across 30 participating EORTC sites across Europe.
  • The Phase II study is a single arm, multicenter study.

LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA

Retrieved on: 
Monday, December 28, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Health, GABAA receptor positive allosteric modulators, Pyridines, Food and Drug Administration, United States Public Health Service, Cholesterol, Clinical trial, Niacin, Lorlatinib, the CROWN Study, Non-Small Cell Lung Cancer, LORBRENA® (lorlatinib), XALKORI® (crizotinib), Pfizer Oncology

The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.

Key Points: 
  • The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.
  • The program allows the FDA to review clinical trial data from certain applications before the complete application is formally submitted.
  • Depending upon the relative importance of each drug, discontinue LORBRENA or the CYP3A inducer for persistent Grade 2 or higher hepatotoxicity.
  • Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter.

Results from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) in Previously Untreated ALK-Positive Lung Cancer Published in the New England Journal of Medicine

Retrieved on: 
Thursday, November 19, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Protein kinase inhibitors, Piperidines, Orphan drugs, Chloroarenes, Lactams, ALK inhibitor, Anaplastic lymphoma kinase, Lorlatinib, Crizotinib, LORBRENA® (lorlatinib), XALKORI® (crizotinib), Pfizer Oncology

Grade 3 or 4 AEs occurred in 72% of people treated with LORBRENA and 56% of people treated with XALKORI.

Key Points: 
  • Grade 3 or 4 AEs occurred in 72% of people treated with LORBRENA and 56% of people treated with XALKORI.
  • LORBRENA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA.

LORBRENA® (lorlatinib) Significantly Improves Progression-Free Survival in First-Line ALK-Positive Lung Cancer

Retrieved on: 
Wednesday, August 5, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Organic compounds, Pyridines, Lactams, GABAA receptor positive allosteric modulators, Lorlatinib, Pyrroles, Hepatotoxicity, Cholesterol, CYP3A, LORBRENA® (lorlatinib), XALKORI® (crizotinib), Pfizer Oncology

IMPORTANT LORBRENA (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Key Points: 
  • IMPORTANT LORBRENA (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
    Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.
  • Depending upon the relative importance of each drug, discontinue LORBRENA or the CYP3A inducer for persistent Grade 2 or higher hepatotoxicity.
  • Overall, 1.5% and 9% of patients required permanent or temporary discontinuation of LORBRENA, respectively, for a CNS effect; 8% required dose reduction.
  • Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter.

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
Chemical compounds, Organic compounds, Tyrosine kinase receptors, ROS1, Lactams, Pyrroles, Pyridines, Lorlatinib, Tyrosine kinase inhibitor, Tyrosine kinase, Protein kinase inhibitor, Entrectinib

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.

Inivata and the European Organisation for Research and Treatment of Cancer (EORTC) collaborate in Phase II NSCLC study

Retrieved on: 
Tuesday, October 29, 2019
European Organisation for Research and Treatment of Cancer, Protein kinase inhibitors, Lorlatinib, Chemical substances, Health, Medicine

The study has been designed to better understand resistance mechanisms and to analyze the correlation between ALK resistance mutational profile and response to lorlatinib.

Key Points: 
  • The study has been designed to better understand resistance mechanisms and to analyze the correlation between ALK resistance mutational profile and response to lorlatinib.
  • Eighty-four patients will be involved in this Phase II study across 30 participating EORTC sites in Belgium, France, Italy, The Netherlands, Norway, Spain and the United Kingdom.
  • EORTC is a highly regarded leader in translation research and we look forward to working with them on this important study.
  • European Organisation for Research and Treatment of Cancer conducts clinical research in cancer, defining new standards of practice for better treatment and care of cancer patients.

Excelera Network® and Pfizer Partner for Distribution of World's First Treatment for Transthyretin Amyloid Cardiomyopathy

Retrieved on: 
Thursday, October 3, 2019
Branches of biology, RTT, Proteins, Metabolic disorders, Histopathology, Structural proteins, Protein folding, Amyloidosis, Amyloid, Pfizer, Fabry disease, Lorlatinib

The two oral medications will be used in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization due to ATTR-CM.

Key Points: 
  • The two oral medications will be used in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization due to ATTR-CM.
  • ATTR-CMis a rare and life-threatening disease characterized by a buildup of abnormal deposits of amyloid protein in the heart, which can result in restrictive cardiomyopathy and progressive heart failure.
  • Pfizer has since also granted the Excelera network access to DAURISMO (glasdegib), LORBRENA (lorlatinib), TALZENNA (talazoparib) and Vizimpro (dacomitinib).
  • To learn more about the Excelera Network, visit https://www.excelerarx.com/
    The Excelera Network is comprised of integrated delivery networks, health systems, and large academic medical centers with a deep commitment to caring for complex pharmacy patients.