Analyst John Newman of Canaccord takes yesterday's FDA approval of Novartis' chimeric antigen receptor T-cell (CAR-T) therapy Kymriah as a meaningful victory for Kite Pharma Inc's (NASDAQ:KITE) fellow CAR-T therapy candidate Axi-cel.
"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", said FDA Commissioner Scott Gottlieb.
An FDA advisory committee had recommended the therapy for approval in July to treat the relapse of a blood cancer known as B-cell acute lymphoblastic leukemia, or ALL. While this was a groundbreaking approval, the therapy will cost $475,000 for 1 treatment, according to Kaiser Health News.
The CAR-T cell treatment developed by Novartis and the University of Pennsylvania is the first type of gene therapy to hit the USA market - and one in a powerful but expensive wave of custom-made "living drugs" being tested against blood cancers and some other tumors, too.
Most patients with ALL recover through other treatments such as radiation, chemotherapy and stem cells. The FDA said hospitals and clinics must become certified to distribute the treatment, meaning they are prepared to recognize and treat CRS and other potentially fatal neurological events.
Each dose of Kymriah contains a patient's own immune cells, which are sent to a lab to be genetically modified using a virus. Once re-injected into the patient's body, the T cells modified to replicate quickly, and the remission is rapid.
The therapy is being licensed and brought to market by the pharmaceutical company Novartis.
"Novartis is collaborating with (Centers for Medicaid Services) to make an outcomes-based approach available to allow for payment only when pediatric and young adult ALL patients respond to Kymriah by the end of the first month".
The price of the therapy is tagged at around $500,000. An immune overreaction called "cytokine release syndrome" can trigger high fevers, plummeting blood pressure and in severe cases organ damage, requiring special care to tamp down those symptoms without blocking the cancer attack. Because Kymriah can have life-threatening side effects, including unsafe drops in blood pressure, the FDA is requiring that hospitals and doctors be specially trained and certified to administer it, and that they stock a certain drug needed to quell severe reactions.
For now, it is only approved for use on ALL.
Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, is excited by the drug's approval, but he has some reservations. This is elegant science. "There is still much more work to do", Lichtenfeld told Healthline. The safety and effectiveness of Kymriah was tested in one small clinical trial of 63 children and young adults with relapsed or refractory B-cell precursor ALL. Even then, it is prescribed only as a last resort when other forms of treatment have failed.
Still, "a far higher percentage of patients go into remission with this therapy than anything else we've seen to date with relapsed leukemia", said Dr. Ted Laetsch of the University of Texas Southwestern Medical Center, one of the study sites.
See more here:
FDA Approves New Cancer Treatment - Alive For Football
- Pompe Disease Treatment Market Supply Demand Report, Top Companies, Research Forecast, Analysis and (Volume and Value) and Growth to 2025 Shared in... - August 6th, 2020
- Molecular Diagnostics Market Economic Impact 2020: Key Trends, Challenges and Standardization, Research, Key Players with Market Dynamics and Forecast... - August 6th, 2020
- Edited Transcript of TECH.OQ earnings conference call or presentation 4-Aug-20 1:00pm GMT - Yahoo Finance - August 5th, 2020
- In Depth Analysis and Survey of COVID-19 Pandemic Impact on Global Precision Cancer Therapies Market Report 2020 Key Players Abbott Laboratories,... - August 5th, 2020
- Hemophilia Treatment Market 2020 By End-User Demand, Emerging Trend, New Innovations, Future Prospect, Detailed Analysis and Forecast 2027 - MR... - August 4th, 2020
- Poignant photos reveal how sickness and healthcare touch so many facets of life - CNN - August 4th, 2020
- Cancer Biological Theraphy Market Future Prospects 2020 Business Growth, Development Factors, Applications, Dynamics, Segments, Size and Demand... - August 4th, 2020
- US Parkinsons disease treatment Market set to grow with massive rate by 2020 to 2025 - Galus Australis - August 3rd, 2020
- Precision Cancer Therapies Market Size of Dynamics, Products, Application, Forecast Report 2019-2025 - The Daily Chronicle - August 3rd, 2020
- Global Age Related Macular Degeneration (AMD) Market: Industry Analysis and Forecast (2019-2026) By Type, Drug, Stages, Route of Administration, Age... - August 3rd, 2020
- BioMarin (BMRN) to Report Q2 Earnings: What's in the Cards? - Zacks.com - August 2nd, 2020
- Trending Now: Retinal Dystrophy Treatment Market Size, Analytical Overview, Growth Factors, Demand, Trends and Forecast to 2026|, Spark Therapeutics... - August 1st, 2020
- BioMarin (BMRN) to Report Q2 Earnings: What's in the Cards? - Yahoo Finance - July 31st, 2020
- Cancer Therapy Market Projected Growth Rate 2020 | Demand Status, Future Scope, Upcoming Trends of Manufacturers, Global Share with Industry Size... - July 31st, 2020
- Global Huntington's Disease Treatment Market- Industry Analysis and Forecast (2019-2027)- By Drug Type, Treatment, End-Users, and Region. - Red &... - July 29th, 2020
- Global Blood Screening Market Size, Share, Industry Growth Survey by Types, Applications and Top Key Players Enzo Biochem Inc., Meridian Bioscience,... - July 28th, 2020
- Global EPrescription Market Research Along With COVID-19 Impact Analysis, Advancement and Outlook 2027|eclinicalworks, Henry Schein, Inc., Drfirst,... - July 28th, 2020
- Hemophilia Treatment Market Size & Share 2020 Analysis and Oulook Report till 2026 - Northwest Trail - July 27th, 2020
- Clinical Laboratory Services Market - Detailed Analysis of Current and Future Industry Figures till 2027 | Global Players Mayo Foundation for Medical... - July 27th, 2020
- Global Ventilators Market Projections & Future Opportunities Recorded for the Period until 2027|ResMed., Medtronic, BD, Getinge AB., Drgerwerk AG... - July 27th, 2020
- Cancer Biological Theraphy Market Size, Share Global Opportunities, Trends, Regional Overview, Global Growth, Leading Company Analysis, And Key... - July 27th, 2020
- Ligament Repair Procedures Market 2020 Global Industry Analysis By Size, Growth Rate, Share and Trends With Forecast To 2027 - Owned - July 27th, 2020
- Global Cell Therapy Technologies Market : Industry Analysis and Forecast (2019-2026) by Product, Technique, End Users and Region. - Red & Black... - July 27th, 2020
- 2027 Projections: Gene Therapy for CNS Disorders Market Report By Type, Application And Regional Outlook - Bulletin Line - July 26th, 2020
- Report: The Impact of COVID-19 On Global Angelman Syndrome Treatment Market : Dynamics, Segments, Size and Demand, 2018 2028 - The Cloud Tribune - July 25th, 2020
- Deep Brain Stimulation Systems Market Growth, Scope, Future Trends, Industry Outlook: Post COVID Investors Eye Bigger-Than-Expected: Beijing PINS... - July 24th, 2020
- Cannabis Can Relieve the Pain Associated With Sickle Cell Anemia Study Shows - Gilmore Health News - July 24th, 2020
- Global Medical Transcription Market Impact of COVID-19 Outbreak on Business Opportunities and Future Scope till 2027|iMedX, Inc., Global Medical... - July 24th, 2020
- Gene Therapy Market Share Analysis, Future Insights, Growth Projection and Industry Trends By 2025 - Jewish Life News - July 23rd, 2020
- Neuroblastoma Drug Market Trend Analysis by 2026 | Cellectar Biosciences, INC, United Therapeutics Corporation, APEIRON Biologics AG - Cole of Duty - July 22nd, 2020
- Kubota Vision Announces Research Agreement with The Research Foundation for the State University of New York for a Wearable Myopia Control Device -... - July 22nd, 2020
- Tumor Infiltrating Lymphocytes Market Growth Analysis by Juno Therapeutics, Inc., Novartis AG, Oxford Biomedica, Pfizer Inc., Precision Biosciences -... - July 22nd, 2020
- Global EPrescription Market (Covid 19 Update) Future Growth Analysis, Business Demand and Opportunities to 2027|Drfirst, Relayhealth, CPSI,... - July 22nd, 2020
- Clinical Laboratory Services Market 2020 Strategies and Insight Driven Transformation to 2027 | Global Players Mayo Foundation for Medical Education... - July 21st, 2020
- Short Read Sequencing Market Share Analysis to 2027 | GenScript., 10x Genomics., Macrogen Inc, QIAGEN, Agilent Technologies, Inc., BGI - Cole of Duty - July 21st, 2020
- Annual Review 2020 highlights impact on growth and productivity in the UK cell and gene therapy industry - PharmiWeb.com - July 20th, 2020
- Epigenetics Market to Witness an Outstanding Growth by 2025 - Cole of Duty - July 20th, 2020
- Cancer Therapy Market Overview, Cost Structure Analysis, Growth Opportunities and Forecast to 2024 - 3rd Watch News - July 18th, 2020
- Cancer Therapy Market 2020 | Remarkable Growth Factors with Industry Size & Share, New Innovations of Leading Players & Forecast till 2024 -... - July 18th, 2020
- Gene Therapy Market Size Is Expected to Grow at a CAGR of 40.7% By 2025 | Share Analysis, Growth Outlook, COVID-19 Impact and Size Estimation -... - July 17th, 2020
- Choroideremia Treatment Market Business Growth by Copernicus Therapeutics, Inc, Wize Pharma Inc, Spark Therapeutics, Inc - 3rd Watch News - July 17th, 2020
- Juvenile Macular Degeneration (Stargardt Disease) Treatment Market to Generate Huge Revenue in Industry by 2025 - 3rd Watch News - July 17th, 2020
- Pompe Disease Treatment Market Trends, Demand, Global Analysis and Forecast to 2030 - Cole of Duty - July 17th, 2020
- Edited Transcript of HMED.ST earnings conference call or presentation 16-Jul-20 12:00pm GMT - Yahoo Finance - July 17th, 2020
- Oxygen Therapy Market 2020-2027 | Need for High-Speed Transport to Boost Growth | Technavio - 3rd Watch News - July 16th, 2020
- Precision Cancer Therapies Market 10-year Forecast and Trends Analysis Research Report - Jewish Life News - July 16th, 2020
- ORTHOPEDIC BRACES AND SUPPORTS MARKET IS THRIVING WORLDWIDE WITH DJO GLOBAL, ZIMMER BIOMET, MEDTRONIC, SMITH AND NEPHEW, STRYKER, SSUR, NUVASIVE, INC... - July 16th, 2020
- Clinical Perinatal Software Market Share Analysis With Top 10 Companies of Industry like Huntleigh Healthcare Limited; GENERAL ELECTRIC COMPANY;... - July 16th, 2020
- Global Negative Pressure Wound Therapy Market Segmentation, Trends, Growth, Competitive Analysis and Geographical Outlook till 2024 - Cole of Duty - July 16th, 2020
- Bone Wax Market Size to Represent 3.5% CAGR By 2023 | COVID-19 Impact Analysis, Competitive Outlook, Share Estimation and Industry Insights - Press... - July 16th, 2020
- Alpha Thalassemia Market 2019 | Analyzing The Impact Followed By Restraints, Opportunities And Projected Developments | DataIntelo - Jewish Life News - July 15th, 2020
- Covid 19- Impact Alpha Thalassemia Market Estimated To Experience A Hike in Growth | Global Industry Size, Growth, Segments, Revenue, Manufacturers -... - July 15th, 2020
- Covid-19 Outbreak: Gene Therapy for Age-related Macular Degeneration Market Insights and Forecast 2020 to 2025 - Owned - July 15th, 2020
- Covid-19 Outbreak: Hemophilia Treatment Market 2020 to 2025: Industry Scope of the Research - Owned - July 15th, 2020
- Gene Therapy Market Size Is Projected to Register a CAGR of 40.7% By 2025 - Jewish Life News - July 14th, 2020
- Orthopedic Prosthetics Market Trend Analysis by Smith and Nephew, Touch Bionics Inc, Zimmer Boimet Holdings Inc., Stryker Corp - Jewish Life News - July 14th, 2020
- Brain Tumor Treatment Market 2020 Review, Future Growth, Global Survey, impact of COVID-19 on Indepth Analysis, Share, Key Findings, Company Profiles,... - July 14th, 2020
- Vision Care Market Size Projection, Cost Structure Analysis, Sales Statistics, Growth Estimation and Industry Insights By 2025 - Daily Research... - July 14th, 2020
- Osteoarthritic Pain Management Treatment Market Trend Analysis by Boehringer Ingelheim International GmbH, Abbott, AbbVie Inc., Astellas Pharma -... - July 14th, 2020
- Impact on COVID-19 Medical Tapes and Bandages Industry : Identify the types of companies that could potentially benefit from the impact of COVID-19 |... - July 14th, 2020
- Choroideremia Treatment Market Share Analysis by Copernicus Therapeutics, Inc, Wize Pharma Inc, Spark Therapeutics, Inc - Daily Research Advisor - July 13th, 2020
- Magnetic Resonance Imaging (MRI) Market Applications, Future Trends, Size Value, Growth Statistics, Sales Projection and COVID-19 Impact Analysis By... - July 13th, 2020
- Anastomosis Device Market Size, Product, Application, Trends, Growth Opportunities, Analysis and Forecast to 2027 - Daily Research Chronicles - July 13th, 2020
- Hemophilia Treatment Market Size & Share 2020 Research Report Covering COVID-19 Impact on Growth Analysis and Outlook till 2026 - Red & Black... - July 13th, 2020
- 3 Top Healthcare Stocks to Buy Right Now - The Motley Fool - July 12th, 2020
- Global Precision Cancer Therapies Market Growth is Projected to Grow at Sluggish Rate by 2027 Post COVID 19 Pandemic Abbott Laboratories, Bayer... - July 12th, 2020
- Medical Imaging Market Outlook and in-Depth Analysis 2020 by Top Players: Spectrum Health, RamSoft, Inc., InHealth Group, Radiology Reports online -... - July 12th, 2020
- MEDICAL ANIMATION MARKET COMPETITIVE STRATEGIES AND WORLDWIDE DEMAND WITH TOP PLAYERS-INFUSE MEDIA GROUP, LLC., HYBRID MEDICAL ANIMATION, GHOST... - July 11th, 2020
- HEALTH INSURANCE MARKET Analysis 2020 With COVID 19 Impact Analysis| Leading Players, Industry Updates, Future Growth, Business Prospects, In-depth... - July 11th, 2020
- Global Carrier Screening Market 2020 Business Outlook with Pandemic Scenario Analysis and Forecast 2027|Myriad Genetics, Inc., Pathway Genomics,... - July 11th, 2020
- Global Brain Tumor Treatment Market Market Size, Trends, Technological Advancement And Growth Analysis With Forecast to 2027 - Cole of Duty - July 10th, 2020
- Global Nicotine Addiction Treatment Market 2020 Business Outlook with Pandemic Scenario Analysis and Forecast 2026|Sosei Group Corporation, CV... - July 10th, 2020
- Global Precision Cancer Therapies Market Briefing 2020, Trends, Applications, Types, Research, Forecast To 2025 - Red & Black Student Newspaper - July 10th, 2020
- Global Tissue-Replacement Products Market to Witness Rapid Development During the Period 2017 2025 - Lake Shore Gazette - July 10th, 2020
- Global Ethical Pharmaceuticals Market Leading Manufacturers Profiles by Industry Size, Share, Trends and Forecast 2027|GlaxoSmithKline plc, Johnson... - July 10th, 2020
- Menkes Syndrome Market 2020 Industry Overview, Key Players Analysis, Emerging Opportunities, Comprehensive Research Study, Competitive Landscape and... - July 10th, 2020
- SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK TREATMENT MARKET TO 2025: SANOFI, PFIZER INC., ELI LILLY AND COMPANY, BRISTOL-MYERS SQUIBB COMPANY -... - July 10th, 2020
- Gene Therapy for Age-related Macular Degeneration Market Size : Industry Growth, Competitive Analysis, Future Prospects and Forecast 2025 - Jewish... - July 8th, 2020
- Autolus: Progress Developing Next Generation Car-T Therapies Ought To Lift Share Price - Seeking Alpha - July 8th, 2020
- Pharmaceutical and Biotechnology Machines Market: How the Business Will Grow in 2027? - Apsters News - July 8th, 2020