Capecitabine

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

Retrieved on: 
Tuesday, 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

Retrieved on: 
Friday, March 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: 
Thursday, January 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: 
Friday, January 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

Retrieved on: 
Tuesday, January 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

Key Points: 


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

Retrieved on: 
Tuesday, January 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

Key Points: 


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

Retrieved on: 
Tuesday, January 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

Key Points: 


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

Processa Pharmaceuticals Provides Interim Analysis from Ongoing Phase 1b Trial of Next Generation Capecitabine Showing Improved Safety Over Capecitabine

Retrieved on: 
Tuesday, December 19, 2023
NGC, Fireside, Metabolism, Fireside chats, FDA, Pharming, PCSA, Acral lentiginous melanoma, Cancer, Capecitabine, Patient, Safety, Pharmaceutical industry

HANOVER, MD, Dec. 19, 2023 (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 safety and efficacy for more cancer patients, provides an interim analysis from its Phase 1b study of its Next Generation Capecitabine (NGC-Cap).

Key Points: 
  • We are encouraged to be near completion of the Phase 1b trial as we make preparations for a subsequent Phase 2 trial with NGC-Cap,” said David Young, Pharm.D., Ph.D., President of Research and Development at Processa.
  • “We are very encouraged with the interim results from the Phase 1b trial.” added Dr. Young.
  • It is believed that NGC-Cap’s ability to inhibit the production of catabolites like FBAL is key to the success of NGC-Cap.
  • Content from the Fireside Chat will be archived through June 20, 2024.

G1 Therapeutics Presents New Post Hoc Analyses Indicating That Patients Who Previously Received Trilaciclib Have Improved Overall Survival with Subsequent Anticancer Therapy

Retrieved on: 
Tuesday, December 5, 2023
Patient, TNBC, Survival, Tumor microenvironment, Neoplasm, CD8, Immune system, Death, Bone marrow, Gemcitabine, G1 Therapeutics, PD-1, Trilaciclib, Carboplatin, Progression-free survival, Mouse, Therapy, Metastasis, Capecitabine, Poster, SACT, CDK, OS, Taxane, PFS, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Dec. 05, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the presentation of new data describing the long-term positive survival impact of previous treatment with trilaciclib and cytotoxic chemotherapy (gemcitabine/carboplatin; GCb) in patients with metastatic triple negative breast cancer (mTNBC) who participated in G1’s Phase 2 trial (NCT02978716). The poster is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th to 9th in San Antonio, TX, and is available on the G1 Therapeutics website here.

Key Points: 
  • Administering trilaciclib with cytotoxic chemotherapy also led to improved survival in patients unable to receive SACT.
  • “These new analyses indicate that trilaciclib can protect the bone marrow and immune system against the harmful effects of cytotoxic therapy, leading to significantly improved survival outcomes among patients who receive subsequent anticancer therapies,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics.
  • After a median follow-up of 12.7 months on study, deaths were observed in 22/43 patients in the trilaciclib plus GCb group and 17/20 patients in the GCb-only group (no trilaciclib).
  • Median time on treatment was 5.5 months in the trilaciclib plus GCb group and 3.3 months in the GCb-only group.

Processa Pharmaceuticals Issues Letter to Shareholders Highlighting Corporate Strategy, Drug Pipeline, and Outlook

Retrieved on: 
Wednesday, November 29, 2023
Forward, Quality of life, NGC, Science, Intellectual property, Metabolism, Drug development, FDA, Lung, NCE, Irinotecan, PCSA, Research, Cancer, Gastroparesis, Human, Capecitabine, IP, New chemical entity, Patient, Safety, Therapy, History, ODR, Pharmaceutical industry

That will not change under my direction, and much of my experience is in oncology and leading business transactions.

Key Points: 
  • That will not change under my direction, and much of my experience is in oncology and leading business transactions.
  • However, many issues and limitations are associated with the use of chemotherapy.
  • Many patients simply cannot tolerate a chemotherapy dose high enough to benefit from its use due to chemotherapy’s toxic side effects.
  • Working in our favor are deep management and R&D teams that have significant and direct experience in clinical drug development.