Febrile neutropenia

U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

Retrieved on: 
Vendredi, février 3, 2023
Biotechnology, FDA, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Hospitals, Science, Clinical Trials, Orbis, TTD, Woman, Physician, EORTC, Diarrhea, Abdominal pain, HER2, Pneumonia, Breast cancer, IHC, Febrile neutropenia, Priority review, Patient, Education, HIV disease progression rates, Colitis, Incidence, Vomiting, Food, Gilead Sciences, Neoplasm, Risk, European Medicines Agency, Clinical, Journal of the National Comprehensive Cancer Network, Category 1, Death, NCCN, Survival, White, MD, Progression-free survival, Sacituzumab govitecan, Multimedia, TPC, Neutropenia, Neutrophil, Global Health, Type, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, PFS, Overalls, UCSF, UCSF Helen Diller Family Comprehensive Cancer Center, Pharmaceutical industry, Dietary supplement

Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network® (NCCN®) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®)i.

Key Points: 
  • Trodelvy is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network® (NCCN®) as defined in the Clinical Practice Guidelines in Oncology (NCCN Guidelines®)i.
  • View the full release here: https://www.businesswire.com/news/home/20230131006182/en/
    “Despite decades of advances, people living with pre-treated HR+/HER2- metastatic breast cancer need new treatment options.
  • In a post-hoc analysis, data demonstrated Trodelvy’s efficacy across HER2-low and IHC0 status in pre-treated metastatic breast cancer patients in the TROPiCS-02 trial.
  • The European Medicines Agency has also validated a Type II Variation Marketing Authorization Application for Trodelvy in HR+/HER2- metastatic breast cancer.

G1 Therapeutics Announces Upcoming 2023 Readouts from its Phase 2 and Pivotal Phase 3 Clinical Trials of Trilaciclib

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Lundi, janvier 9, 2023
PARK, Trilaciclib, Control, Toxicity, Overalls, Prognosis, OS, Bevacizumab, Febrile neutropenia, Anemia, CRC, Therapy, PFS, DMC, Neutropenia, Response evaluation criteria in solid tumors, Grade 3, FOLFOXIRI, MUC, Colorectal cancer, Safety, FDA, Aplastic anemia, Risk, Thrombocytopenia, Data monitoring committee, Tumor microenvironment, Carboplatin, Maintenance, GC, TNBC, Survival, Patient, Bone marrow, Chain reaction, Pivotal, RESEARCH, Avelumab, Diarrhea, Pharmaceutical industry, Fine chemical, Medical imaging, Initial

RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the 2023 data readouts that are expected to drive its near-term and long-term indications and potential future treatment paradigms for some of the most aggressive and refractory cancers, including metastatic colorectal (mCRC), bladder or urothelial cancer (mUC), and triple negative breast cancer (TNBC).

Key Points: 
  • “But the high toxicity of these cytotoxic agents poses a risk of serious adverse events that can compromise patient well-being and patient outcomes.
  • Depending on the tumor type and the chemotherapy backbone, this mechanistic profile can drive patient benefits of myeloprotection and/or anti-tumor efficacy.
  • Initial results provided in January 2023 indicate that the confirmed objective response rate as of the cutoff date was comparable between arms.
  • G1 expects to release initial PFS data from PRESERVE 1 on the combination of trilaciclib administered prior to FOLFOXIRI and bevacizumab in 4Q23.

CytomX Therapeutics Provides Business Update and Outlines 2023 Company Priorities

Retrieved on: 
Jeudi, janvier 5, 2023
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SOUTH SAN FRANCISCO, Calif., Jan. 05, 2023 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced its 2023 company priorities and provided a pipeline update which included anticipated milestones for 2023, recent progress and achievements in its wholly owned and collaboration pipeline, and a data update for the Phase 2, CX-2029 cohort expansion study. The company will host a call with investors today to review the CX-2029 cohort expansion study data and potential key pipeline events for 2023.

Key Points: 
  • The company plans to rapidly advance this potentially best-in-class program towards clinical evaluation with an IND filing targeted for the second half of 2023.
  • The company anticipates filing an IND for this novel ADC in the second half of 2023.
  • CytomX enters 2023 in a strong strategic position and with significant momentum in its pipeline.
  • CytomX management will host a conference call and a simultaneous webcast today, January 5th 2023 at 5 p.m.

Athenex Announces Quantum Leap Healthcare Collaborative Reports Positive Trial Result of I-SPY2 Trial for Oral Paclitaxel in Combination with PD-1 and Carboplatin in Neoadjuvant Breast Cancer

Retrieved on: 
Mardi, décembre 20, 2022
Cancer, Patient, Peripheral neuropathy, PD-1, Carboplatin, Febrile neutropenia, Paclitaxel, Oral, Pharmaceutical industry

Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia.

Key Points: 
  • Oral paclitaxel, relative to intravenous paclitaxel, was associated with less neuropathy and was not associated with an increase in febrile neutropenia.
  • Quantum Leap Healthcare Collaborative anticipates presenting these results at upcoming national meetings in Q2 of 2023.
  • “We are very pleased that the Oral Paclitaxel combination regimen graduated from this prestigious program which has brought exciting and innovative treatments to neoadjuvant breast cancer patients.
  • This study confirms our finding of less neuropathy for Oral Paclitaxel compared to intravenous paclitaxel in our metastatic breast cancer study.

Geron Announces Positive Top-Line Results from IMerge Phase 3 Trial of Imetelstat in Lower Risk MDS

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Mercredi, janvier 4, 2023
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Imetelstat patients also experienced a statistically significant (p=0.042) and clinically meaningful mean reduction in RBC transfusion units compared to placebo.

Key Points: 
  • Imetelstat patients also experienced a statistically significant (p=0.042) and clinically meaningful mean reduction in RBC transfusion units compared to placebo.
  • “The notable results from IMerge Phase 3 underscore our belief that, with the unique mechanism of action of imetelstat as a telomerase inhibitor, the drug has the potential to become a first-in-class therapy for lower risk MDS patients.
  • “The IMerge Phase 3 efficacy results illustrate the depth, breadth and durability of transfusion independence potentially achievable with imetelstat treatment, which could be practice changing, if approved.
  • A conference call with Geron management to review the IMerge Phase 3 top-line results is scheduled at 8 a.m. Eastern Time this morning and may be accessed on Geron’s website.

BeyondSpring Presents Positive Data with Plinabulin for the Prevention of Docetaxel-Induced Neutropenia in Patients with Non-Small Cell Lung Cancer and Breast Cancer at Three Medical Conferences

Retrieved on: 
Mardi, décembre 13, 2022
Breast cancer, Prostate cancer, Squamous cell carcinoma, Neutropenia, Bone pain, B cell, Quality of life, Drug discovery, Eli Lilly, Medicine, G-CSF, CIN, Harvey, EGFR, DSN, Cancer, Platelet, JCO, Literature, SCLC, Multiple myeloma, Overalls, Stanford University School of Medicine, DIN, Large-cell lung carcinoma, Docetaxel, ASH, APC, NCCN, FN, Survival, HSPC, Society, Therapy, MM, ANC, Patient, Febrile neutropenia, Medical imaging, Pharmaceutical industry, Copper, Plinabulin, NSCLC

In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer (BC in the 105 study ) at the 2022 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • In addition, data was presented on plinabulin for the prevention of docetaxel-induced neutropenia in breast cancer (BC in the 105 study ) at the 2022 San Antonio Breast Cancer Symposium (SABCS).
  • “Docetaxel-induced neutropenia can cause life-threatening infections in cancer patients, and the current standard of care, prophylactic treatment with a G-CSF in high-risk patients, has limitations.
  • “The data that we presented at these three conferences demonstrate that plinabulin can provide solutions for some of the challenges seen with G-CSF.
  • The plinabulin and G-CSF combination for the prevention of CIN has demonstrated positive Phase 3 data in the PROTECTIVE-2 study.

Ellipses Pharma Presents Preliminary Data From the First in Human Phase-1/2 Trial of EP0042, a Dual FLT-3 and Aurora Kinase Inhibitor, at ASH

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Lundi, décembre 12, 2022
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EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.

Key Points: 
  • EP0042 is being developed as a new potential treatment to combat acquired resistance to FLT3 inhibitors in patients with AML.
  • The preliminary data is based upon 25 patients across 6 dose cohorts including patients with FLT3 mutated and wild type AML at the point of enrolment.
  • The median number of prior treatments was 2 (range 1-6), with a number of patients having received a prior FLT3 inhibitor.
  • EP0042 is a dual FLT3 and Aurora kinase inhibitor under development as a potential treatment for AML patients who have developed FLT3 inhibitor resistance.

Syros Presents Safety Lead-in Data from SELECT-AML-1 Trial Evaluating Tamibarotene in Combination with Venetoclax and Azacitidine and Announces Plans to Initiate Randomized Portion of Phase 2 Trial

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Samedi, décembre 10, 2022
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As of October 13, 2022, eight newly diagnosed, unfit, RARA-positive patients had been enrolled in the trial, including six who were evaluable for response.

Key Points: 
  • As of October 13, 2022, eight newly diagnosed, unfit, RARA-positive patients had been enrolled in the trial, including six who were evaluable for response.
  • - Tamibarotene in combination with venetoclax and azacitidine administered at approved doses showed no evidence of increased toxicity relative to the doublet combination of venetoclax and azacitidine.
  • This includes rates of myelosuppression, which were comparable to reports with venetoclax and azacitidine in this population.
  • The randomized portion is expected to initiate in Q1 2023, with data expected in 2023 or 2024.

Spectrum Pharmaceuticals’ ROLVEDON™ (eflapegrastim-xnst) Injection Added to NCCN Supportive Care Guidelines in Oncology for Hematopoietic Growth Factors

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Mardi, décembre 6, 2022
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Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology announced today that ROLVEDON (eflapegrastim-xnst) has been added to the latest National Comprehensive Cancer Network Supportive Care Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth Factors.

Key Points: 
  • Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology announced today that ROLVEDON (eflapegrastim-xnst) has been added to the latest National Comprehensive Cancer Network Supportive Care Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth Factors.
  • The NCCN guidelines are a standard resource for determining the best course of treatment and supportive care for people living with cancer.
  • The inclusion in the NCCN guidelines further reinforces the clinical profile of ROLVEDON and is an important milestone for the program.
  • REDEFINING CANCER CARE and ROLVEDON are the Spectrum Pharmaceuticals logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.

Treadwell Therapeutics Announces A Presentation at the 2022 ASH Annual Meeting Featuring a Clinical Trial Update on CFI-400945, an oral PLK4 inhibitor

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Mardi, décembre 13, 2022
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The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.

Key Points: 
  • The poster presentation described the preliminary results from the monotherapy dose optimization portion of the TWT-202 in advanced leukemias.
  • "CFI-400945 had previously shown single agent complete remissions in refractory high risk AML.
  • Treadwell Therapeutics is a science driven, clinical-stage, multi-modality biotechnology company developing first-in-class and best-in-class medicines to address unmet needs in patients with cancer.
  • The Company's internally developed clinical pipeline includes CFI-400945, CFI-402257 (TTK inhibitor) and CFI-402411 (HPK1 inhibitor).