Acral lentiginous melanoma

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

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Friday, January 5, 2024
Marketing, Hypothyroidism, INN, Woman, Progression-free survival, Nausea, Syndrome, Heart, Cancer, Inflammation, Skull, Proteinuria, Anatomy, Cell division, IIA, Diarrhea, Fatigue, ATC, Capsule, Bleeding, Pancreas, RET, VEGF, FGFR, Cerebral edema, Neoplasm, Stroke, Enzyme, Liver failure, Safety, Kidney cancer, Arthralgia, Heart failure, Patient, Urine, Medical Subject Headings, Stomatitis, Immune system, Everolimus, International, Encephalopathy, Language, Somatic symptom disorder, Blood, Mouth, Catherine Disher, Select, Medicine, Vomiting, Pembrolizumab, Cholesterol, PDGF, Kidney failure, Weight loss, Headache, KIT, Brain, Acral lentiginous melanoma, Swelling, Hypoesthesia, Splenic infarction, Confusion, European Medicines Agency, RCC, Kidney, Growth, Sunitinib, Hypercholesterolemia, Rash, Medical device

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

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

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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.

Seagen to Highlight Overall Survival Data for PADCEV® and TIVDAK® during Presidential Symposium at ESMO Congress 2023

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Monday, October 16, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Diabetes, Fatal, Weakness, Female, Skin, PD-L1, Creatinine, DKA, Nausea, Swelling, Keratitis, Pneumonia, Birth, PD-1, Hair, Neutrophil, Male, Peripheral neuropathy, Lipase, Acute kidney injury, Blood, Stevens–Johnson syndrome, Toxic epidermal necrolysis, Diabetic neuropathy, Toxicity, Bulla, Temperature, Appetite, Itch, SJS, Fetus, Cornea, Conjunctivitis, Hyperglycemia, Dermatitis, Evaluation, Hypoxia, Pain, Diabetic ketoacidosis, Pembrolizumab, ILD, Risk, Liver, Lymphocyte, Grade 2, Rash, Erythema, Fatigue, Acral lentiginous melanoma, Pneumonitis, Papule, Incidence, Dysgeusia, Anemia, Cough, Urinary tract infection, Diarrhea, Erythroderma, Periodic breathing, TEN, Patient, MUC, PN, Drug eruption, Septic shock, Pharmaceutical industry, Medical imaging, Palladium

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.

Key Points: 
  • Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV.
  • When PADCEV was given in combination with pembrolizumab, the incidence of skin reactions, including severe events, occurred at a higher rate.
  • Skin reactions occurred in 72% (all grades) of the 121 patients treated with PADCEV in combination with pembrolizumab in clinical trials.
  • The majority of the skin reactions that occurred with combination therapy included maculo-papular rash, macular rash and papular rash.

Processa Pharmaceuticals Provides Data Update Supporting a Potential Personalized Treatment Approach for Improved Cancer Care

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Thursday, August 17, 2023
Acral lentiginous melanoma, Capecitabine, Pharming, Cancer, DPD, Gastrointestinal cancer, PCSA, Plasma, NGC, De novo synthesis, Metabolism, Patient, Physician, Patient safety, Colorectal cancer, Safety, Pharmaceutical industry, Vaccine, MD

HANOVER, MD, Aug. 17, 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 efficacy and safety for patients suffering from cancer, provides an interim analysis from its ongoing Phase 1B trial of Next Generation Capecitabine (NGC-Cap) in patients with gastrointestinal cancer, which identifies a personalized treatment approach that may yield improved safety and treatment efficacy. NGC-Cap combines the administration of PCS6422, Processa’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of the commonly used chemotherapy capecitabine, which is metabolized to 5-fluorouracil (5-FU) in the body. DPD promotes the further metabolism of 5-FU to fluor-beta-alanine (FBAL), a metabolite that leads to dose-limiting chemotherapy side effects.

Key Points: 
  • DPD promotes the further metabolism of 5-FU to fluor-beta-alanine (FBAL), a metabolite that leads to dose-limiting chemotherapy side effects.
  • Processa has found that regularly measuring the concentrations of DPD, as expressed by the metabolite FBAL, may provide a method to better understand how each patient responds to different NGC-Cap dosage regimens.
  • Currently, capecitabine, among the most widely used chemotherapy drugs, is dosed based on a standard dosage regimen for all patients.
  • Unfortunately, many patients cannot tolerate that dose and must either have their dose reduced or have their treatment interrupted.

LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

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Friday, May 26, 2023
MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Head, DO, Cancer, Patient, Stomatitis, Risk, Merck, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, Esophageal cancer, Abstract, Death, Apoptosis, Lenvatinib, Overalls, PFS, Eisai, CR, Stomach, ORR, Acral lentiginous melanoma, Arm, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, Hypothyroidism, ASCO, Central Time Zone, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Annual general meeting, Nausea, Society, Pharmaceutical industry, EU

After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, LENVIMA plus KEYTRUDA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for LENVIMA plus KEYTRUDA versus 69.6% and 60.2% for sunitinib, respectively.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received LENVIMA plus KEYTRUDA versus 60.3% of patients who received sunitinib.
  • These findings reinforce the important role of LENVIMA plus KEYTRUDA as a first-line standard of care treatment option for patients with advanced renal cell carcinoma."

LianBio Announces Topline Results from Phase 2a Proof of Concept Trial Evaluating Infigratinib in Patients with Gastric Cancer & Receipt of Breakthrough Therapy Designation in China

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Tuesday, June 6, 2023
FGFR, Acral lentiginous melanoma, Therapy, Diarrhea, Progression-free survival, DOR, Clinical trial, Breakthrough therapy, Constipation, Gene amplification, Patient, Anemia, Hyperphosphatemia, National Medical Products Administration, FGFR2, Stomach, NMPA, ORR, Safety, Disease, Pharmaceutical industry, Medical imaging

The topline results from the gastric cancer and gastroesophageal junction adenocarcinoma cohort demonstrated a confirmed ORR of 25.0% (n=20).

Key Points: 
  • The topline results from the gastric cancer and gastroesophageal junction adenocarcinoma cohort demonstrated a confirmed ORR of 25.0% (n=20).
  • “Gastric cancer impacts a disproportionately high number of patients in China,” said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio.
  • The topline data from this proof-of-concept trial suggest infigratinib has the potential to provide meaningful clinical benefit in third-line or later gastric cancer.
  • LianBio expects to work with investigators to present detailed results from the clinical trial at an upcoming medical meeting.

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Thursday, May 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Everolimus, RECIST, Head, DO, Cancer, Patient, Stomatitis, Risk, NYSE, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, MRK, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, IMDC, Esophageal cancer, Memorial Sloan Kettering Cancer Center, PD-1, Abstract, Death, Safety, Lenvatinib, Overalls, Multimedia, PFS, CR, Stomach, ORR, Acral lentiginous melanoma, IRC, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, MSKCC, Hypothyroidism, EDT, ASCO, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Quality of life (healthcare), Annual general meeting, Nausea, Interpretation, Society, Pharmaceutical industry, Dietary supplement, Merck, EU, Eisai

After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for KEYTRUDA plus LENVIMA versus 69.6% and 60.2% for sunitinib, respectively.
  • Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received KEYTRUDA plus LENVIMA versus 60.3% of patients who received sunitinib.

Teddi Mellencamp Gets Naked for Melanoma Awareness Month

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Monday, May 1, 2023
Neutrogena, MRF, Acral lentiginous melanoma, Skin cancer, Australian Melanoma Research Foundation, Bristol Myers Squibb, Research, Social media, Mile, Melanoma, Eisai, Patient, Personality, Skin, Pharmaceutical industry

WASHINGTON, May 1, 2023 /PRNewswire-PRWeb/ -- The Melanoma Research Foundation (MRF) is pleased to announce the launch of its annual award-winning #GetNaked campaign in recognition of Melanoma Awareness Month this May. TV personality, wellness coach, host of the top-rated podcast "Two Ts in a Pod," melanoma survivor and advocate Teddi Mellencamp will serve as this year's #GetNaked campaign spokesperson. In this role, Teddi will join the MRF's #GetNaked campaign focused on generating awareness around early-detection and educating the public about melanoma prevention.

Key Points: 
  • WASHINGTON, May 1, 2023 /PRNewswire-PRWeb/ -- The Melanoma Research Foundation (MRF) is pleased to announce the launch of its annual award-winning #GetNaked campaign in recognition of Melanoma Awareness Month this May.
  • In this role, Teddi will join the MRF's #GetNaked campaign focused on generating awareness around early-detection and educating the public about melanoma prevention.
  • "Teddi Mellencamp is an incredible melanoma advocate dedicated to raising awareness and encouraging early detection of this preventable disease," says MRF CEO Kyleigh LiPira.
  • The MRF would like to thank its Melanoma Awareness Month corporate sponsors, Bristol Myers Squibb , Neutrogena , Cabana Life and Eisai for their generous support.

Processa Pharmaceuticals Announces First Patient Dosed in the 300 mg Dose Group with Next Generation Chemotherapy-Capecitabine

Retrieved on: 
Friday, March 17, 2023
NOT, Capecitabine, Acral lentiginous melanoma, Survival, Cancer, Quality of life, Cardiotoxicity, PCSA, NGC 3311, Patient, FDA, Safety, Pharmaceutical industry, Processa edulis, MD

The 300 mg dose group will provide more information on the drug exposure vs adverse event relationship which is critical to FDA approval given the FDA’s Project Optimus Oncology initiative.

Key Points: 
  • The 300 mg dose group will provide more information on the drug exposure vs adverse event relationship which is critical to FDA approval given the FDA’s Project Optimus Oncology initiative.
  • In mid-April Processa expects guidance from FDA on our Phase 2B trial design and our Project Optimus approach.
  • HANOVER, MD, March 17, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a developer of Next Generation Chemotherapies (NGCs), today announced that the Company has dosed the first patient in its NGC-Capecitabine (combination of PCS6422 and capecitabine) 300 mg dose group.
  • “We are pleased to have now dosed the first patient in our 300 mg dose group.

Indian Researchers from ACTREC Discover Novel Therapeutic Agent for a Host of Diseases

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Tuesday, January 17, 2023
Neurodegeneration, Cell, Fatality, Atomic energy, Metastasis, DNA damage (naturally occurring), Chromosome, Chromatin, Cytokine, Acral lentiginous melanoma, DNA, Copper, Resveratrol, Surgical oncology, Diarrhea, Treatment, Copper toxicity, Genetically modified bacteria, Emeritus, DNA repair, Protein, Patient, Saliva, Sepsis, Mouse, Bone marrow, Transplant, Research, Vomiting, Serum, Tata Memorial Centre, Inflammation, Incidence, Alzheimer's disease, RESCU, Department of Atomic Energy, ACTREC, Docetaxel, Translational research, Vaccine, TMC, Cancer

MUMBAI, India, Jan. 17, 2023 /PRNewswire/ -- Chromatin comprises a complex mixture of DNA and proteins and forms the structural basis of chromosomes in the cellular nuclei. When cells die, they release cell-free chromatin particles or "cfChPs" into the circulatory system. Emerging evidence indicates that cfChPs exert toxic effects by damaging the DNA of healthy cells and activating pro-inflammatory processes. Researchers from the Advanced Centre for Treatment, Research & Education in Cancer (ACTREC), Tata Memorial Centre (TMC), India, have recently demonstrated therapeutic benefits of a pro-oxidant mixture of resveratrol and copper, R-Cu, in patients undergoing chemotherapy for advanced gastric cancer. Combining R with Cu (R-Cu) leads to the generation of free oxygen radicals which can inactivate the offending cfChPs.

Key Points: 
  • When cells die, they release cell-free chromatin particles or "cfChPs" into the circulatory system.
  • Emerging evidence indicates that cfChPs exert toxic effects by damaging the DNA of healthy cells and activating pro-inflammatory processes.
  • Researchers from the Advanced Centre for Treatment, Research & Education in Cancer (ACTREC), Tata Memorial Centre (TMC), India, have recently demonstrated therapeutic benefits of a pro-oxidant mixture of resveratrol and copper, R-Cu, in patients undergoing chemotherapy for advanced gastric cancer .
  • Combining R with Cu (R-Cu) leads to the generation of free oxygen radicals which can inactivate the offending cfChPs.