Olaparib

New Research in JNCCN Evaluates Cost-Effectiveness of Olaparib, a PARP Inhibitor, for Metastatic Pancreatic Cancer

Retrieved on: 
Thursday, November 12, 2020
Organic compounds, Orphan drugs, PARP inhibitors, Lactams, Olaparib, Phthalazines, Chemical compounds, National Comprehensive Cancer Network, NCCN, Pancreatic cancer, Cancer, Oncology

Thus, either improved patient selection for maintenance olaparib or reduced drug costs are likely necessary to establish olaparib as a cost-effective therapy in metastatic pancreatic cancer."

Key Points: 
  • Thus, either improved patient selection for maintenance olaparib or reduced drug costs are likely necessary to establish olaparib as a cost-effective therapy in metastatic pancreatic cancer."
  • Complimentary access to " Cost-Effectiveness of Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer " is available until February 10, 2021.
  • More than 25,000 oncologists and other cancer care professionals across the United States readJNCCNJournal of the National Comprehensive Cancer Network.
  • The National Comprehensive Cancer Network ( NCCN ) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education.

Foundation Medicine Expands Indication for FoundationOne®Liquid CDx to be used as a Companion Diagnostic for LYNPARZA®

Retrieved on: 
Monday, November 9, 2020
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Medicine, Clinical medicine, Health, Orphan drugs, Lactams, Medical tests, Antineoplastic drugs, Foundation Medicine, Hoffmann-La Roche, Olaparib, Companion diagnostic, CDX, FoundationOne Liquid CDx, FoundationOne CDx, Foundation Medicine

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for LYNPARZA (olaparib).

Key Points: 
  • Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for LYNPARZA (olaparib).
  • Foundation Medicines tissue-based comprehensive genomic profiling test, FoundationOneCDx, was approved as a companion diagnostic for LYNPARZA in May 2020.
  • The CGP test is now approved as a companion diagnostic for seven targeted therapies across four tumor types.
  • 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 .

SEngine Precision Medicine’s PARIS® Test Identifies Novel Drug Combinations for PARP Inhibitor Resistant Ovarian Cancer in Study Published in EBioMedicine

Retrieved on: 
Tuesday, October 20, 2020
Cancer, Clinical medicine, Medicine, RTT, Oncology, PARP inhibitors, Ovarian cancer, Poly (ADP-ribose) polymerase, Olaparib

SEATTLE, Oct. 20, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine ,a precision oncology company revolutionizing cancer diagnostics anddrug discoveryby pre-testing drugs on patient-derivedtumor organoids, announced today that the PARIS Test was utilized in a study to identify novel drug combinations to overcome resistance to PARP inhibitors in ovarian cancer.

Key Points: 
  • SEATTLE, Oct. 20, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine ,a precision oncology company revolutionizing cancer diagnostics anddrug discoveryby pre-testing drugs on patient-derivedtumor organoids, announced today that the PARIS Test was utilized in a study to identify novel drug combinations to overcome resistance to PARP inhibitors in ovarian cancer.
  • PARP inhibitors are targeted drugs that have become the standard of care in the treatment of nearly half of ovarian cancers.
  • In this study, researchers used a combination of high throughput siRNA screening and drug testing assays using patient derived tumor cells to identify clinically relevant drug combinations for patients whose tumors were resistant to PARP inhibitors.
  • While we could not help this first patient, this study nominates a novel drug combination for PARP inhibitor resistant ovarian cancer, which could be tested in clinical trials.

Cyclacel Pharmaceuticals to Present at the October 2020 Lytham Partners Virtual Investor Growth Conference

Retrieved on: 
Monday, October 5, 2020
Orphan drugs, Life sciences, Organic compounds, Health, Cyclacel, Biotechnology, Olaparib, Sapacitabine, Biopharmaceutical

BERKELEY HEIGHTS, N.J., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc.(Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announces that the Company is scheduled to participate in a virtual presentation and fireside chat at the October 2020 Lytham Partners Virtual Investor Growth Conference on Thursday, October 8, 2020 at 8:00am ET.

Key Points: 
  • BERKELEY HEIGHTS, N.J., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc.(Nasdaq:CYCC, Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, announces that the Company is scheduled to participate in a virtual presentation and fireside chat at the October 2020 Lytham Partners Virtual Investor Growth Conference on Thursday, October 8, 2020 at 8:00am ET.
  • A webcast of the presentation will be posted under the investor relations section of Cyclacels website at www.cyclacel.com , or can be accessed at www.webcaster4.com/Webcast/Page/2522/37808 or www.lythampartners.com/virtual .
  • Cyclacel Pharmaceuticalsis a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation, and DNA damage response biology.
  • An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer.

Cyclacel Announces Fadraciclib Abstract Selected for Oral Presentation in the Late Breaking and Best Proffered Paper Session at the 32nd EORTC-NCI-AACR Symposium 2020

Retrieved on: 
Monday, September 21, 2020
Chemical compounds, Organic compounds, Orphan drugs, Heterocyclic compounds, Venetoclax, Olaparib, Sapacitabine, Phosphoinositide 3-kinase inhibitor

The data is from an ongoing Phase 1 study of fadraciclib as a single agent in patients with advanced solid tumors.

Key Points: 
  • The data is from an ongoing Phase 1 study of fadraciclib as a single agent in patients with advanced solid tumors.
  • Fadraciclib (CYC065) is a potent orally and intravenously available inhibitor of CDK2 and CDK9.
  • Fadraciclib is also being evaluated in Phase 1 combination studies with venetoclax in patients with relapsed or refractory CLL and AML/MDS.
  • An investigator-sponsored trial (IST) is evaluating an oral combination of sapacitabine and olaparib in patients with BRCA mutant breast cancer.

LYNPARZA® (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer

Retrieved on: 
Monday, September 21, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Drugs, Health, Clinical medicine, Orphan drugs, RTT, Angiogenesis inhibitors, Bevacizumab, PARP inhibitors, Ovarian cancer, Progression-free survival, Olaparib, Oncology, PAOLA-1, LYNPARZA® (olaparib), Ovarian Cancer, Homologous Recombination Deficiency, the AstraZeneca and Merck Strategic Oncology Collaboration, Merck

The addition of LYNPARZA to bevacizumab improved progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.

Key Points: 
  • The addition of LYNPARZA to bevacizumab improved progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
  • Discontinuation of treatment due to ARs occurred in 20% of patients on LYNPARZA in combination with bevacizumab.
  • For patients with advanced ovarian cancer, the primary aim of first-line maintenance treatment is to delay disease progression for as long as possible.
  • Dr. Jos Baselga, executive vice president, oncology R&D, AstraZeneca, said, Half of all patients with advanced ovarian cancer have HRD-positive tumors.

LYNPARZA® (olaparib) Reduced the Risk of Death by 31% in BRCA1/2 or ATM-mutated Metastatic Castration-Resistant Prostate Cancer in Phase III Profound Trial

Retrieved on: 
Sunday, September 20, 2020
Radiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical trials, Organic compounds, Drugs, Clinical medicine, Prostate cancer, RTT, Androstanes, Pyridines, Antineoplastic drugs, Abiraterone acetate, Chemotherapy, MCRPC, Olaparib, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Homologous Recombination Repair (HRR) Gene Mutations, PROfound, LYNPARZA, the AstraZeneca and Merck strategic oncology collaboration, AstraZeneca in oncology, AstraZeneca

AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial testing LYNPARZA as a 1st-line medicine for patients with mCRPC in combination with abiraterone versus abiraterone alone.

Key Points: 
  • AstraZeneca and Merck are exploring additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial testing LYNPARZA as a 1st-line medicine for patients with mCRPC in combination with abiraterone versus abiraterone alone.
  • Do not start LYNPARZA until patients have recovered from hematological toxicity caused by previous chemotherapy (Grade 1).
  • Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, LYNPARZA can cause fetal harm.
  • LYNPARZA is the foundation of AstraZenecas industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

LYNPARZA® (olaparib) Approved in the EU for Germline BRCA-mutated Metastatic Pancreatic Cancer

Retrieved on: 
Wednesday, July 8, 2020
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Organic compounds, PARP inhibitors, Chemical compounds, Lactams, Breast cancer, Heterocyclic compounds, Olaparib, Pancreatic cancer, BRCA mutation, Talazoparib, Triple-negative breast cancer, POLO, LYNPARZA® (olaparib), Pancreatic Cancer, BRCA Mutations, the AstraZeneca and Merck Strategic Oncology Collaboration, Merck

Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.

Key Points: 
  • Approximately 5-7% of patients with metastatic pancreatic cancer have a germline BRCA mutation.
  • LYNPARZA now provides clinicians with a targeted, well-tolerated treatment option for patients with germline BRCA-mutated metastatic pancreatic cancer.
  • In the POLO trial, LYNPARZA nearly doubled median progression-free survival versus placebo after first-line chemotherapy for patients with germline BRCA-mutated metastatic pancreatic cancer.
  • LYNPARZA is now the only approved PARP inhibitor in biomarker-selected patients with metastatic pancreatic cancer.

Myriad Receives FDA Approval of BRACAnalysis CDx® as a Companion Diagnostic for Lynparza® in HRR-mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, May 20, 2020
Cancer, Organic compounds, Lactams, PARP inhibitors, Neoplasms, Breast cancer, AstraZeneca, Olaparib, Phthalazines, Prostate cancer, MCRPC, BRCA1

Food and Drug Administration(FDA) approved the BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib).

Key Points: 
  • Food and Drug Administration(FDA) approved the BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib).
  • This approval is our seventh regulatory approval for BRACAnalysis CDx in support of Lynparza and further demonstrates our commitment to improve the lives of patients with cancer, said Nicole Lambert, president Myriad Oncology and Womens Health.
  • The BRACAnalysis CDx test provides clinicians with the vital information needed to quickly match patients with an appropriate treatment option.
  • BRACAnalysis CDx is the only FDA-approved germline test to identify men with BRCA1 and BRCA2mutations, a subpopulation of HRR gene mutations.

LYNPARZA® (Olaparib) Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, May 20, 2020
Oncology, FDA, Health, Pharmaceutical, Cardiology, Biotechnology, RTT, Histopathology, Prostate cancer, PARP inhibitor, Olaparib, Neoplasms, Cancer, Causes of death, Metastatic Castration-Resistant Prostate Cancer, Homologous Recombination Repair (HRR) Mutations, PROfound, LYNPARZA® (olaparib), the AstraZeneca and Merck Strategic Oncology Collaboration, AstraZeneca in Oncology, AstraZeneca

I am thrilled by the approval of LYNPARZA which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate cancer in the US.

Key Points: 
  • I am thrilled by the approval of LYNPARZA which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate cancer in the US.
  • Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: Today marks the first approval for LYNPARZA in prostate cancer.
  • Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said, LYNPARZA is the only PARP inhibitor approved with Phase III data for men with HRR gene-mutated metastatic castration-resistant prostate cancer.
  • This is different in cancer cells, where a mutation in HRR pathways leads to abnormal cell growth and therefore cancer.