Capecitabine

Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-escalating Trial with NGC-Cap in Gastrointestinal Cancer

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Dienstag, Juni 11, 2024
Patient, MTD, PCSA, Index, Safety, Cancer, Capecitabine, Doctor of Pharmacy, RECIST, Neoplasm, Maxima and minima, PFS, Breast cancer, PR, Pharmaceutical industry

HANOVER, MD., June 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial which defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for Next Generation Capecitabine (NGC-Cap) administered to patients with Stage III or IV gastrointestinal tract (GI) cancer.

Key Points: 
  • “We are encouraged by the preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrating some anti-tumor activity in patients with advanced GI cancer who have progressive cancer after relapsing or not responding to prior therapy.
  • The favorable response is likely due to NGC-Cap’s ability to distribute more 5-FU to cancer cells than monotherapy capecitabine.
  • The promising Phase 1b safety and tolerability profile plus these early efficacy signals provide validation for further development of NGC-Cap,” stated David Young, PharmD, Ph.D., President of Research and Development at Processa.
  • These two dosage regimens will be further evaluated in the Phase 2 trial in breast cancer patients to determine the optimal dosage regimen for the pivotal trial.

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

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Freitag, Mai 24, 2024
Patient, Tislelizumab, Survival, Osteosarcoma, Liver, HER2, Colorectal cancer, SOX, Safety, Sarcoma, Neoadjuvant therapy, University Challenge 2013–14, Trial of the century, PD-1, LARC, FRU, CAPOX, Capecitabine, Sintilimab, MSS, Pharmaceutical industry

Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)

Key Points: 
  • Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE)
    A propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world data
    Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter study
    A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survival
    Fruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial
    Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II study
    Fruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II study
    Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trial
    Efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective study
    Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study
    Surufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II Study
    Phase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysis

Processa Pharmaceuticals Presents Two Abstracts at the AACR Annual Meeting 2024 Including New Data on the NGC-Cap Phase 1b Trial

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Donnerstag, April 11, 2024
FDA, Project, NGC, Safety, Food, Abstract, PCSA, Plasma, Publication, Incidence, Patient, Doctor of Pharmacy, Database, Capecitabine, AACR, AUC, ODR, Breast cancer, Pharmaceutical industry

HANOVER, Md., April 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, presented two abstracts at the American Association for Cancer Research (AACR) Annual Meeting 2024, including new Phase 1b data on its Next Generation Capecitabine (NGC-Cap) product. These abstracts are available in the Publications section of Processa’s website.

Key Points: 
  • The NGC-Cap Phase 1b trial evaluated ascending doses of capecitabine when combined with a fixed dose of PCS6422 in patients with advanced, relapsed, or refractory progressive gastrointestinal cancer.
  • NGC-Cap demonstrated greater 5-FU (5-fluorouracil) exposure and lower fluoro-beta-alanine (FBAL) exposure with a better or similar side effect profile compared with monotherapy capecitabine.
  • “The most recent data for the Phase 1b NGC-Cap study presented at AACR highlight NGC-Cap’s ability to distribute more 5-FU to cancer cells with 5-10 times greater systemic exposure than when capecitabine is administered alone.
  • “This Phase 1b study is ongoing due to continued patient response and we plan to release final trial data once the database is locked.

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

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Dienstag, April 2, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Breast cancer, Goserelin, Patient, Lung, Social media, Immunoglobulin G, National Cancer Institute, Neoplasm, Merck & Co., TNBC, Capecitabine, DXD, BRCA, Clinical Cancer Research, Metabolism, Immunology, Biopharmaceutical, World Health Organization, Cancer, Safety, ADC, BLA, Daiichi Sankyo, Vinorelbine, IHC, Mutation, NSCLC, Disease, Merck, AKT, Death, MD, AstraZeneca, PARP, Oncotarget, PFS, FDA, OS, HER2, Eribulin, Cleavage, Progression-free survival, Triple-negative breast cancer, Female, Emerging, Olaparib, Biology, Sapporo Medical University, Medicine, Pharmaceutical industry

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

FDA Roundup: March 22, 2024

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Freitag, März 22, 2024
Health, Capecitabine, PFAS, FCN, Dietary supplement, OCE, Risk, COVID-19, Patient, Warning, Tablet, Public, RNA, DNA, Animal, News, Plasma protein binding, Emergency Use Authorization, Human services, Role, System, SARS-CoV-2, Physical examination, Plasmodium vivax, Plasmodium falciparum, Highlight, Malaria, Heated tobacco product, CFR, Vaccination, Safety, DPD, Cosmetics, Growth, Vaccine, Plasmodium ovale, Marketing, Food, FDA, Multimedia, Ponatinib

On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.

Key Points: 
  • On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
  • From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
  • On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
  • These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.

Processa Pharmaceuticals Announces Successful Completion of Phase 1b Safety Evaluation of NGC-Cap in Patients with Advanced Cancer Resulting in Recommended Phase 2 Doses

Retrieved on: 
Donnerstag, Januar 25, 2024
Capecitabine, Patient, Incidence, NGC, Doctor of Pharmacy, Breast cancer, Cancer, HFS, Safety, PCSA, FDA, Aplastic anemia, BID, Metabolism, Physician, Pharmaceutical industry

HANOVER, MD, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces the successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine (“NGC-Cap”). From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial. The Phase 2 trial will be in advanced or metastatic breast cancer given FDA’s agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer.

Key Points: 
  • From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial.
  • The Phase 2 trial will be in advanced or metastatic breast cancer given FDA’s agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer.
  • The NGC-Cap Phase 1b trial evaluated capecitabine doses from 75 mg once a day (QD) to 225 mg twice a day (BID).
  • Although the primary objective of the Phase 1b trial in patients with advanced gastrointestinal (GI) cancer was not to evaluate efficacy, the Phase 1b trial was designed to provide some preliminary data on efficacy.

Processa Pharmaceuticals Announces Expansion of NGC-Cap Program into Advanced or Metastatic Breast Cancer

Retrieved on: 
Freitag, Januar 19, 2024
Capecitabine, Woman, Patient, Doctor of Pharmacy, Breast cancer, Cancer, Safety, PCSA, FDA, Breast, Colorectal cancer, Logic, Prevalence, Pharmaceutical industry

HANOVER, MD, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, announces it plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. Following the Processa meeting with the FDA, Processa has decided the next NGC-Cap trial would be a Phase 2 trial in breast cancer. This decision was supported through discussions with the FDA where Processa agreed with the FDA that pursuing breast cancer will lead to a more efficient development program while providing a greater likelihood of FDA approval. The FDA stated that the previously generated data in past and existing studies could be used to directly support the Phase 2 trial in breast cancer.

Key Points: 
  • Following the Processa meeting with the FDA, Processa has decided the next NGC-Cap trial would be a Phase 2 trial in breast cancer.
  • “We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer.
  • Breast cancer is the most diagnosed cancer, representing approximately 15% of all new cancer patients in 2023.
  • Over 150,000 women are currently living with advanced or metastatic breast cancer.

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

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Dienstag, Januar 2, 2024
Stomach, Liver, Medical Subject Headings, Diarrhea, Marketing, Prostate cancer, Neck, Prednisolone, Stomatitis, Breast, INN, Cyclophosphamide, HER2, Breast cancer, ATC, Trastuzumab, Hair loss, International, Stomach cancer, Prednisone, Lung cancer, Weakness, Neutropenia, Nausea, Language, Mouth, Cisplatin, Cancer, Inflammation, Head, Testosterone, Neoplasm, Dexamethasone, Neutrophil, Blood, Non-small-cell lung cancer, Capecitabine, European Medicines Agency, Skeleton, Fluorouracil, Doxorubicin, Select, Cell, Patient, Anatomy, Medicine, Anemia, Vomiting, IIA, Prostate, Medical imaging

Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

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Human medicines European public assessment report (EPAR): Taxotere, docetaxel, Date of authorisation: 27/11/1995, Revision: 51, Status: Authorised

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

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Dienstag, Januar 2, 2024
Marketing, Stomach, INN, Risk, HER2, Breast, Tissue, Heart, Cancer, Neoplasm, Cardiotoxicity, Infection, Anatomy, Paclitaxel, IIA, Breast cancer, ATC, European, Allergy, Metastasis, Blood, Capecitabine, MBC, EBC, Safety, Heart failure, MGC, Patient, Medical Subject Headings, Agency, European Commission, Cyclophosphamide, Immune system, Docetaxel, Carboplatin, International, Language, Cisplatin, Select, Enzyme inhibitor, Medicine, FISH, Radiation, Lymph, Arm, European Medicines Agency, Fluorouracil, Doxorubicin, Medical device

Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

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Human medicines European public assessment report (EPAR): Herzuma, trastuzumab, Date of authorisation: 09/02/2018, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

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Dienstag, Januar 2, 2024
Marketing, Platinum, Artery, INN, HER2, Histology, Hypertension, Cancer, Neoplasm, Anatomy, Paclitaxel, IIA, Diarrhea, Breast, Fatigue, Breast cancer, ATC, Embolism, Bleeding, VEGF, Weakness, Abdomen, Capecitabine, Pregnancy, Human, Safety, Gynaecology, NSCLC, Patient, Medical Subject Headings, Peritoneum, EGFR, Carboplatin, International, FIGO, Nutrient, Language, Blood, Cisplatin, Rectum, Oxygen, Anthracycline, Select, Ovary, Lung cancer, Allergy, Recurrence, European Medicines Agency, Growth, Doxorubicin, Taxane

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

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Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised