Pyrroles

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

Retrieved on: 
Friday, May 7, 2021
Cancer treatments, Clinical medicine, Drugs, Orphan drugs, Antineoplastic drugs, Breakthrough therapy, Indoles, Pyrroles, Sunitinib, Pembrolizumab, Society of Gynecologic Oncology, SGO

These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data.

Key Points: 
  • These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data.
  • "We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications.
  • "\nThe applications in advanced RCC are based on results from the CLEAR study (Study 307/KEYNOTE-581), in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib.
  • These data were presented in March at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women\'s Cancer.

RECORDATI: POSITIVE RESULTS FROM THE PHASE III LINC 4 STUDY PRESENTED AT THE ENDOCRINE SOCIETY’S ANNUAL MEETING REINFORCE THE EFFICACY AND SAFETY OF ISTURISA® (OSILODROSTAT) IN CUSHING’S DISEASE

Retrieved on: 
Tuesday, March 23, 2021
Adrenal gland disorders, Chemical compounds, Orphan drugs, Organ systems, Imidazoles, Nitriles, Osilodrostat, Pyrroles, Health, Cushing's syndrome, Cushing's disease, Placebo-controlled study

These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.

Key Points: 
  • These data provide further evidence of the benefits of Isturisa as an effective and well-tolerated oral treatment option for patients with Cushings disease.
  • The key secondary endpoint was also met, with the majority (81%) of patients having normal mUFC levels at week 36.
  • We are delighted that the positive and statistically significant data from the LINC 4 study have been presented at the Endocrine Societys Annual Meeting.
  • Osilodrostat is an effective and well-tolerated treatment for Cushing's disease (CD): results from a Phase III study with an upfront, randomized, double-blind, placebo-controlled phase (LINC 4); presented at ENDO 2021, March 2021.

Recordati Rare Diseases: Positive Results From the Phase III LINC 4 Study Presented Today at the Endocrine Society’s Annual Meeting Reinforce the Efficacy and Safety of Isturisa® (osilodrostat) in Cushing’s Disease

Retrieved on: 
Tuesday, March 23, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, Health, Clinical trials, Other Health, Chemical compounds, Orphan drugs, Clinical trials, Imidazoles, Nitriles, Osilodrostat, Pyrroles, Placebo-controlled study, Organic compounds, Medical research

All patients received open-label Isturisa after week 12 until the end of the core study (week 48).

Key Points: 
  • All patients received open-label Isturisa after week 12 until the end of the core study (week 48).
  • We are delighted that the positive and statistically significant data from the LINC 4 study have been presented at The Endocrine Societys Annual Meeting.
  • Osilodrostat is an effective and well-tolerated treatment for Cushings disease (CD): results from a Phase III study with an upfront, randomized, double-blind, placebo-controlled phase (LINC 4).
  • This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group.

Deciphera Pharmaceuticals Completes Target Enrollment in the INTRIGUE Phase 3 Clinical Study of QINLOCK® (Ripretinib) in Patients with Second-Line Gastrointestinal Stromal Tumor

Retrieved on: 
Monday, November 30, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Health sciences, Clinical medicine, Cancer treatments, Pyridines, Orphan drugs, Indoles, Pyrroles, Sunitinib, Ripretinib, Gastrointestinal stromal tumor, Imatinib, QINLOCK (ripretinib), GIST, Deciphera Pharmaceuticals

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).
  • The INTRIGUE Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib.
  • This study was designed to support regulatory approvals in second-line GIST patients in the United States, Europe, and other major markets.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

Cogent Biosciences Announces Final Results from PLX9486 Phase 1/2 Study in Advanced GIST Patients at CTOS 2020

Retrieved on: 
Wednesday, November 18, 2020
Pyrroles, Indoles, Sunitinib, Clinical medicine, Gastrointestinal stromal tumor, Cancer, Gist, Kit, Medicine, Antineoplastic drugs, Ripretinib, Evofosfamide

CAMBRIDGE, Mass., Nov. 18, 2020 /PRNewswire/ -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the final results from its PLX9486 + sunitinib Phase 1/2 study in patients with advanced gastrointestinal stromal tumors (GIST).

Key Points: 
  • CAMBRIDGE, Mass., Nov. 18, 2020 /PRNewswire/ -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced the final results from its PLX9486 + sunitinib Phase 1/2 study in patients with advanced gastrointestinal stromal tumors (GIST).
  • "We are pleased to share final results from our Phase 1/2 trial of PLX9486 + sunitinib and are excited to advance this combination into a Phase 3 GIST trial in the second half of 2021," said Andrew Robbins, President and CEO of Cogent Biosciences.
  • Title:The potent and selective kit inhibitor PLX9486 dosed in combination with sunitinib demonstrates promising progression free survival (PFS) in patients with advanced gastrointestinal stromal tumor (GIST): final results of a phase 1/2 study.
  • Out of the 18 patients with advanced GIST enrolled in the trial, all patients had received prior treatment, including 67% of patients with at least three prior lines of therapy.

ESMO 2020: Cabometyx® (cabozantinib) in Combination With Opdivo® (nivolumab) Demonstrates Significant Survival Benefits in Patients With Advanced Renal Cell Carcinoma in Pivotal Phase III CheckMate -9ER Trial

Retrieved on: 
Saturday, September 19, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Cancer treatments, Antineoplastic drugs, Clinical medicine, RTT, Indoles, Pyrroles, Sunitinib, Breakthrough therapy, Renal cell carcinoma, Nivolumab, Protein kinase inhibitor

Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.

Key Points: 
  • Cabometyx in combination with Opdivo was associated with a longer duration of response than sunitinib, with a median duration of 20.2 months versus 11.5 months.
  • All these key efficacy results were consistent across the pre-specified International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk and PD-L1 subgroups.
  • The CheckMate -9ER data demonstrate meaningful efficacy benefits with nivolumab plus cabozantinib, which significantly improved overall survival and doubled progression-free survival and objective response rate with consistent effects observed across pre-specified subgroups.
  • Cabometyx in combination with Opdivo was well tolerated and reflected the known safety profiles of the immunotherapy and tyrosine kinase inhibitor components in previously untreated advanced RCC.

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.

DGAP-News: 4SC AG: Conference call to be hosted on 21 April 2020 to present the Q1 report 2020

Retrieved on: 
Thursday, April 16, 2020
Articles, Life sciences, Health, Pharmacy, Pharmaceutical industry, Pyrroles, Resminostat, Sulfonamides, Biopharmaceutical, Medication

A presentation document supporting the conference call will be available on 21 April 2020, at 4SC's website .

Key Points: 
  • A presentation document supporting the conference call will be available on 21 April 2020, at 4SC's website .
  • 4SC AG is a clinical-stage biopharmaceutical company developing small-molecule drugs that can target key indications in cancer with high unmet medical needs.
  • 4SC's pipeline is protected by a comprehensive portfolio of patents and currently comprises two drug candidates in clinical development: resminostat and domatinostat .
  • The forward-looking statements contained herein represent the judgement of 4SC as of the date of this press release.

Atorvastatin (CAS 134523-00-5) Market Report 2020 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 25, 2020
Health, Pharmaceutical, Chemistry, Physical sciences, Natural sciences, Anilides, Atorvastatin, Diols, Pyrroles, RTT, Statins, Market research, Fluorine

The "Atorvastatin (CAS 134523-00-5) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Atorvastatin (CAS 134523-00-5) Market Research Report 2020" report has been added to ResearchAndMarkets.com's offering.
  • This global report is a result of industry experts' diligent work on researching the world market of Atorvastatin.
  • The report helps to build up a clear view of the market trends and development, identify major players in the industry, and estimate main downstream sectors.
  • The Atorvastatin global market report key points: