Erdafitinib

TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non-muscle-invasive bladder cancer, respectively

Retrieved on: 
Sunday, May 5, 2024
UTI, Congress, FDA, FGFR, Cancer, Urinary diversion, Pyelonephritis, Erdafitinib, Hospital, Safety, Food, American Urological Association, Survival rate, FGFR3, Johnson & Johnson, Recurrence, Abstract, Cohort, BCG, PD-1, PD-L1, Disease, Bladder cancer, Patient, Medicine, AUA, Urinary bladder, MUC, Face, SAN, Sepsis, EAU, Pharmaceutical industry

SAN ANTONIO, May 5, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from an open-label, multicenter, multi-cohort Phase 1 study of the safety and efficacy of TAR-210, an intravesical targeted releasing system designed to provide sustained, local release of erdafitinib into the bladder, in patients with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations. These data were featured today in an Oral Presentation Session (Abstract # PD48-02) at the 2024 American Urological Association (AUA) Annual Meeting taking place May 3-6, 2024, in San Antonio, Texas.

Key Points: 
  • First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress.
  • "Results presented today further underscore that TAR-210 for the localized treatment of bladder cancer may offer a promising alternative for patients with limited treatment options."
  • At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the 2 cohorts.
  • Of the 21 patients in C1 with HR-NMIBC, the 12-month recurrence-free (RF) survival rate was 90%.

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO

Retrieved on: 
Monday, October 16, 2023
Congress, Cohort, HIV disease progression rates, Erdafitinib, Lung cancer, Doctor of Philosophy, Amivantamab, Abstract, Pembrolizumab, Research, NSCLC, PAPILLON, Therapy, Janssen, EGFR, Johnson & Johnson, Janssen Pharmaceuticals, Safety, Disease, Pemetrexed, Oncology, ESMO, Prednisone, Clinical Genitourinary Cancer, BRCA, HRR, Bladder cancer, MUC, European Society for Medical Oncology, Pancreatic cancer, Prostate cancer, Abiraterone acetate, Progression-free survival, FGFR, Patient, Medical imaging, Pharmaceutical industry, Vaccine

RARITAN, N.J., Oct. 16, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that nine oral presentations from the Company's robust solid tumor portfolio and pipeline, with three highlighted in Presidential Symposium sessions, will be featured at the European Society for Medical Oncology (ESMO) 2023 Congress. In total, 19 studies (17 company-sponsored abstracts and two investigator-initiated studies), including seven late-breaking abstracts, will feature new data and updates in lung cancer, bladder cancer, and prostate cancer, highlighting Janssen's pioneering efforts to transform the treatment of solid tumors.

Key Points: 
  • "The data and results premiering at this year's ESMO represent our determination to advance oncology science and set new innovation standards in the treatment of solid tumor malignancies," said Peter Lebowitz, M.D., PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
  • "The evolution of targeted therapeutics in oncology presents a promising path forward to bring the very latest innovations to patients.
  • Data in bladder cancer underscore Janssen's ambition to advance new therapies and approaches to address unmet treatment needs.
  • Building on a legacy in the treatment of prostate cancer, data at ESMO highlight precision-driven and patient-centric strategies across the disease continuum.

Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients with Metastatic or Unresectable Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations After Prior Anti-PD-(L)1 Treatment

Retrieved on: 
Monday, June 5, 2023
Carcinoma, FGFR, Janssen Pharmaceuticals, University, Progression-free survival, Cohort, DOR, CI, OS, Pharmacokinetics, PFS, ASCO, American Society of Clinical Oncology, UC, Patient, Risk, Paris-Saclay University, Confidence interval, Annual general meeting, Johnson & Johnson, Trial of the century, Erdafitinib, Pembrolizumab, Abstract, Death, Society, ORR, Safety, Pharmaceutical industry

CHICAGO, June 5, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from an interim analysis of Cohort 1 of the Phase 3 THOR study, evaluating treatment with BALVERSA® (erdafitinib) versus chemotherapy in patients with metastatic or unresectable urothelial carcinoma (UC) and selected fibroblast growth factor receptor (FGFR) gene alterations who had received prior treatment with an anti-programmed death ligand 1 (PD-[L]1) agent. In this cohort, the study met its primary endpoint of overall survival (OS) and reduced the risk of death by 36 percent.1 Following the accelerated approval of BALVERSA® in 2019, these confirmatory data were featured in a Late-Breaking Presentation Session (Abstract # LBA4619) at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • "The use of BALVERSA® in this setting supports recommendations for FGFR testing in all patients with metastatic urothelial cancer."
  • THOR ( NCT03390504 ) is a Phase 3 randomized, open-label, multicenter study evaluating the efficacy and safety of BALVERSA®.
  • Among the 64 responding patients, three percent of patients had a complete response and 27 percent of patients had a partial response.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.4

Janssen Data at ASCO GU Support Ambition to Transform Treatment of Prostate and Bladder Cancer Through Precision Medicine and Early Intervention

Retrieved on: 
Monday, February 13, 2023
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RARITAN, N.J., Feb. 13, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced plans to present more than 20 abstracts featuring seven oncology therapies from its robust portfolio and pipeline at the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place in San Francisco on February 16-18. Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence and innovative development approaches across all stages of prostate and bladder cancer.  

Key Points: 
  • Building on more than a decade of leadership in the development of medicines for people diagnosed with GU cancers, Janssen will present data demonstrating its ambition to advance patient-centered treatment through precision medicine, real-world evidence and innovative development approaches across all stages of prostate and bladder cancer.
  • "At Janssen, we are focused on early intervention in prostate and bladder cancer and optimizing outcomes through treatment approaches based on the genetic profiles of tumors," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC.
  • "Data featured at this year's ASCO GU reflect the cutting-edge therapies in our portfolio and pipeline and illustrate how Janssen's science is advancing our vision to eliminate cancer."
  • "Presentations at this year's ASCO GU underscore our continuing commitment to addressing the needs of patients living with prostate and bladder cancer at all stages of their disease."

Imagene AI to Demonstrate Real-Time Biomarker Detection From H&E Images at ASCO 2022

Retrieved on: 
Wednesday, June 1, 2022
Science, Ovary, Biomarker, Precision medicine, EGFR, Erdafitinib, Research, Society, H&E, FGFR3, Lung, Deep learning, Marie Cassidy, CEO, ASCO, Biopsy, HER2, Breast, American Society of Clinical Oncology, HRD, GLOBE, Patient, Technology, Oncology, Diagnosis, Gold, AUC, CNS, Lymphatic system, Cancer, McCormick Place, Medical imaging, Medical device, Eosin

CHICAGO, June 01, 2022 (GLOBE NEWSWIRE) -- Imagene AI, an emerging leader in the field of AI-based precision medicine for cancer, today announced that it will demonstrate its molecular and spatial intelligence platform at the 2022 American Society of Clinical Oncology (ASCO) conference.

Key Points: 
  • CHICAGO, June 01, 2022 (GLOBE NEWSWIRE) -- Imagene AI, an emerging leader in the field of AI-based precision medicine for cancer, today announced that it will demonstrate its molecular and spatial intelligence platform at the 2022 American Society of Clinical Oncology (ASCO) conference.
  • Imagene leadership team will offer individual presentations in its ASCO booth, #2086, June 4-6 during exhibiting hours (9:00 a.m. to 5:00 p.m. CDT) at McCormick Place in Chicago.
  • As example of Imagenes biomarker detection capabilities, its abstract, Image-based detection of FGFR3-fusion in urothelial bladder cancer, was accepted for ASCO poster presentation ( Abstract No.
  • Its molecular and spatial intelligence platform delivers real-time biomarker reports using only digitized biopsy images, leading to faster diagnosis and better identification of treatment for patients.

Global Fibroblast Growth Factor Receptor Inhibitor Drug Market to 2026 - Opportunity & Clinical Trials Insights - ResearchAndMarkets.com

Retrieved on: 
Friday, August 13, 2021
Health, Pharmaceutical, Time, Mutation, FGFR, Cros, Bladder cancer, BMS, CAGR, Company, Roche, Cancer, Erdafitinib, Multiple myeloma, AstraZeneca, Novartis, Lymphoma, Breast cancer, Pemigatinib, Pharmaceutical industry

Global Fibroblast Growth Factor Receptor Inhibitor Drug Market Opportunity & Clinical Trials Insight 2026 Report Highlights:

Key Points: 
  • Global Fibroblast Growth Factor Receptor Inhibitor Drug Market Opportunity & Clinical Trials Insight 2026 Report Highlights:
    Global FGFR Inhibitors Market Opportunity: > USD 4 Billion by 2026
    Clinical & Sales Insight on Approved FGFR Inhibitors: 3 (Belvesra, Pemazyre & Truseltiq)
    Comprehensive Clinical Trials Insight by Company, Country, Phase & Patient Segment: 53 Drugs in Trials
    Recent breakthrough with respect to small molecule-based therapy in the oncology segment has set up remarkable achievements in terms of improving the cancer survival rate.
  • Currently, the market of FGFR inhibitors is at nascent stage, which is driven by the sales of 3 approved products of this class i.e.
  • Many new drugs of this class are also believed to get orphan designation in upcoming years, which further boost the market size of this segment.
  • Further, US will lead the FGFR market due to the availability of a huge cancer burden and leading pharmaceutical companies.

Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Pemigatinib as a First-Line Therapy for Cholangiocarcinoma

Retrieved on: 
Tuesday, June 4, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, Research, Other Science, Science, Hepatology, Cancer, Medical specialties, Medicine, RTT, Cholangiocarcinoma, Tyrosine kinase receptors, Fibroblast growth factor receptor 2, Erdafitinib

It is most common in those over 70 years old and is more common in men than women.

Key Points: 
  • It is most common in those over 70 years old and is more common in men than women.
  • FGFR2 fusion genes are drivers of the disease occurring almost exclusively in patients with intrahepatic cholangiocarcinoma (iCCA), a subset of the disease.
  • The incidence of cholangiocarcinoma with FGFR2 rearrangements is increasing and is currently estimated at 2,000-3,000 patients in the U.S., Europe and Japan.
  • The U.S. Food and Drug Administration (FDA) has granted pemigatinib Breakthrough Therapy designation for the second-line treatment of cholangiocarcinoma.

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval

Retrieved on: 
Friday, April 12, 2019
Health, Biotechnology, Oncology, Pharmaceutical, FDA, Otsuka Pharmaceutical, Health, Articles, Astex, Erdafitinib, Cancer, Pharmaceutical industry, Transitional epithelium, Urinary bladder, Taiho Pharmaceutical

Under the ongoing collaboration, Janssen isresponsible for the clinical development and commercialisation of all products, including erdafitinib.

Key Points: 
  • Under the ongoing collaboration, Janssen isresponsible for the clinical development and commercialisation of all products, including erdafitinib.
  • Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.
  • Astex is a leader in innovative drug discovery anddevelopment, committed to the fight against cancer and diseases of the central nervous system.
  • Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: Otsuka people creating new products for better health worldwide.

Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer

Retrieved on: 
Tuesday, September 18, 2018
Cancer, Erdafitinib, Pyrazoles, Quinoxalines, Clinical medicine, Medicine, Janssen Pharmaceutica, Transitional cell carcinoma

Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.

Key Points: 
  • Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.
  • "Erdafitinib has demonstrated promising results in the treatment of metastatic urothelial cancer, a disease where patients unfortunately have limited treatment options today," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.
  • "The erdafitinib FDA submission is an important milestone as we work to bring a new treatment option to patients diagnosed with metastatic urothelial cancer," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.
  • In 2008, Janssen entered into an exclusive worldwide license and collaboration agreement with Astex Pharmaceuticals to develop and commercialize erdafitinib.