Category Archives: Stem Cell Therapy

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By: Peter Marks, M.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration continues to facilitate the development and availability of innovative medical products, such as regenerative medicine therapies, that have the potential to treat or even cure diseases or conditions for which few effective treatment options exist. For example, the agency has recently licensed (approved) its first product that received Regenerative Medicine Advanced Therapy (RMAT) designation, underscoring our ongoing commitment to work with sponsors and manufacturers to bring these products to market.

Unapproved products marketed as regenerative medicine therapies may cause serious harm to patients. Cellular therapies, including stem-cell products, are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately or appropriately studied in clinical trials.

In 2017, the FDA issued guidance on the regulatory framework for regenerative medicine therapies and announced its intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products. This policy gave manufacturers three-and-a-half-years to determine the appropriate regulatory pathway for their products, and if an application is needed, ample time to prepare and submit the appropriate application to the FDA.

Now that we have reached the end of the compliance and enforcement discretion policy period, we are once again reminding manufacturers, clinics, and health care practitioners and providers that the compliance and enforcement discretion policy for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies, ended on May 31, 2021. If manufacturers continue to illegally market unapproved HCT/Ps, they do so at their own risk and may be subject to an enforcement action.

The FDA continues to receive consumer complaints and has warned consumers about unapproved regenerative medicine products and the unfounded claims made in advertisements and direct-to-patient marketing. Despite the FDAs warnings that an IND may be required for these products, many entities still ignore such warnings and offer these unapproved and unproven products, with some consumers subsequently experiencing serious adverse effects.

The compliance and enforcement discretion policy was never intended to excuse the violations of manufacturers or health care providers who are offering unapproved regenerative medicine products that have the potential to put patients at significant risk. The policy did not apply to products that have been associated with reported safety concerns or have the potential to cause significant safety concerns to patients.

Indeed, while the policy was in place, the FDA took swift and aggressive action in the face of serious violations of the law, including some involving patient harm. Since November 2017, the FDA has pursued two enforcement actions for injunction against manufacturers of such violative HCT/Ps.

The FDA prevailed in one of those cases, United States v. US Stem Cell Inc. et al., in June 2019, before the United States District Court for the Southern District of Florida. Earlier this week, the United States Court of Appeals for the Eleventh Circuit affirmed the lower courts judgment. The US Stem Cell decision is a victory for public health and an endorsement of the FDAs work to stop stem cell clinics that place patients at risk by marketing products that violate the law.

The other case for injunction, United States v. Cell Surgical Network et al., is currently being litigated in the United States District Court for the Central District of California. A third enforcement action pursued by the FDA was resolved in March 2018. That case involved the seizure of vials of Vaccinia Virus Vaccine, Live, used to create an unapproved and dangerous stem cell product (a combination of excess amounts of live virus and stromal vascular fraction a stem cell mixture derived from body fat).

The FDA also has taken numerous actions since the compliance and enforcement policy was announced. During this period, the agency issued 14 Warning Letters and 24 Untitled Letters involving violative HCT/Ps regulated under Section 351 of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act and applicable FDA regulations. Additionally, since December 2018, the FDA has issued 400 letters to manufacturers and health care providers who may be offering violative stem cell or related products since December 2018.

The FDA reminds all stakeholders that the agencys acceptance of an establishment registration and HCT/P listing does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or approved by the FDA. It is inappropriate and misleading to advertise establishment registration and product listing in any manner that may imply product approval or compliance with the law.

If manufacturers, clinics, and health care providers offering regenerative medicine products to patients did not contact the FDA about the need for an IND during the period the Tissue Reference Group Rapid Inquiry Program was offered, there remain three options that have been available for many years and these options continue to be available. We want to remind stakeholders that a product that requires but lacks premarket approval may not be lawfully marketed or offered for sale, including when a sponsor has an IND or is pursuing an IND or BLA for its HCT/P.

The FDA is committed to helping advance the development of clinical trials for regenerative medicine products with the shared goal of safe and effective products for patients. We look forward to working with those who share this goal.

For more information: Important Patient and Consumer Information About Regenerative Medicine Therapies

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Innovative Regenerative Medicine Therapies Safety Comes First - FDA.gov

This acquisition expands the operational footprint of Generate Life Sciences across three countries, alongside its distribution network for frozen donor gametes in more than 40 countries. In particular, it further increases access to newborn stem cell preservation and genetic screening services across North America.

"Generate Life Sciences is the natural partner for Cell Care given our established industry and scientific leadership in our respective markets," says Brent Dennison, Chief Executive Officer of Cell Care. "As part of Generate, we will collaborate with Generate's scientific team to support the exciting therapeutic applications for newborn stem cells and deliver great value to the thousands of families who have banked their children's stem cells."

Stem cells derived from umbilical cord sources have numerous emerging clinical uses in regenerative medicine, given their potent anti-inflammatory, immune-modulating and tissue reparative properties. Investigational cellular therapies, derived from umbilical cord blood and tissue, are targeting clinical conditions such as autoimmune disease, acquired neurological diseases and lung disease. Generate and Cell Care have been actively working to research and develop cord blood and cord tissue based therapies through local and international partnerships with leading academic institutions and biotech firms. Most recently, Cell Care helped develop a cord blood trial for patients with COVID-19 respiratory complications and Generate established a biorepository to facilitate investigational studies in both acute and persistent COVID-19 using newborn stem cells through their established network of research partners.

"Newborn stem cells have unique properties which make them a preferred biological source material to adult stem cells for an increasing number of indications," said Jaime Shamonki, MD, Generate's Chief Medical Officer. "With the largest newborn stem cell banks in the United States, Canada and Australia uniting under the Generate Life Sciences family, we have an unprecedented opportunity to create a global infrastructure for collecting, researching and manufacturing newborn stem cells to meet current and future demands for this growing category of therapies."

In Canada and Australia, clients and healthcare professionals will continue working with their local teams at Cell Care, Insception, or Cells for Life. The banks will continue collecting, processing and storing newborn stem cells at their respective facilities, and no revisions will be made to existing processes. However, with their addition into Generate Life Sciences, clients will be able to soon access the full range of family health services offered by the company, which include frozen donor gametes, newborn stem cell preservation and genetic screening. There will be more to announce in this regard in the future.

*This transaction is still pending approval from the Foreign Investment Review Board (FIRB) of Australia, which governs Cell Care.

About Generate Life SciencesGenerate Life Sciences Inc. is a life sciences company helping to grow and protect families through reproductive, newborn stem cell, genetic screening, medical device, and healthcare technology services. We serve families from preconception to post-birth. Our brands CBR (Cord Blood Registry), California Cryobank, Donor Egg Bank USA, NW Cryobank, ReadyGen, Kitazato USA, and Donor Application are pioneering leaders that have helped nearly one million families. Headquartered in Los Angeles, Generate operates facilities in Tucson, New York, Boston, Palo Alto, and Rockville, MD. Generate is a portfolio company of GI Partners, a private investment firm based in San Francisco.

About the Cell Care groupThe Cell Care group comprises Cell Care in Australia, Insception Lifebank, Cells for Life and the Victoria Angel public bank in Canada. The combined group is one of the world's top 10 companies in the sector with more than 200,000 cord blood and tissue samples stored. Cell Care has invested in Australian clinical trials investigating the impact of autologous cord blood in type-1 diabetes and sibling cord blood in cerebral palsy, and has supported research into expansion technologies for a number of years. Prior to the acquisition, Cell Care was a portfolio company of CPE Capital, a private investment firm based in Sydney. Visit http://www.insception.com for more information.

Media ContactAzeem ZeekryaHDMZ [emailprotected] 312-506-5244

SOURCE Generate Life Sciences

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The Generate Life Sciences Family of Companies Grows With the Addition of the Cell Care Group of Cord Blood Banks - PRNewswire

Canine Stem Cell Therapy Market research report documents in-depth analysis of the global and the regional markets on various parameters that drives the market. Market analysis, factual data, and market forecasts are few areas covered in this report. This report also outlines the growth of the markets over the span of years, the changing dynamics of the markets, rules, and laws that govern the regional and international markets, revenue generation and production cost variations, and much more.

The Canine Stem Cell Therapy was valued at 48500 Billion US$ in 2021 and is projected to reach 59700 Billion US$ by 2025, at a CAGR of 6.3% during the forecast period.

The non-invasive stem cell obtaining procedure augmented the possibility of accomplishing high-quality cells, and the lower price of therapy coupled with a high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

Top Key Players Profiled in This Report:VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics,

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The purpose of this study is to define the overview of the Rising Demand for Canine Stem Cell Therapy Market with respect to market size, shares, sales patterns, and pricing structures. Primary and secondary research refer collect the desired data of the target market. Different global regions such as North America, Latin America, Asia-Pacific, Africa, and the Middle East are examined to evaluate the facts about productivity.

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Canine Stem Cell Therapy Market 2021 Analysis and Precise Outlook Therapeutics, Medivet Biologics, Okyanos The Courier - The Courier

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The information made available in the Stem Cell Therapy report will definitely facilitate to increase the knowledge and decision-making skills of the business, thus providing an immense opportunity for growth. This will at last increase the return rate and drive the competitive edge within. Being a custom market report, it provides services tailored to the exact challenge. Whether it is survey work, in-depth interviewing, or a combination of multiple methods, marketing report will match the right methodology and personnel to the business need. Proficient team of analysts gather, analyze, and synthesize the data to accomplish challenging tasks while not setting unrealistic expectations.

The report focuses on the major players that are in operation within the market and their competitive landscape present in the market. The report includes an inventory of initiatives taken by the businesses within the past years. The report has mentioned growth parameters in the regional markets along with major players dominating the regional growth such as North America, Europe, China, Japan, Southeast Asia and India.

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Stem Cell Therapy Market Scenario

The report throws light on the competitive landscape, segmentation, geographical expansion, and revenue, production, and consumption growth of the Stem Cell Therapy market. Stem Cell Therapy Market Size, Growth Analysis, Industry Trend, and Forecast, offers details of the factors influencing the global business scope. This report provides future products, joint ventures, marketing strategy, developments, mergers and acquisitions, marketing, promotions, revenue, import, export, CAGR values, the industry as a whole, and the particular competitors faced are also studied in the large-scale market.

Stem Cell Therapy Market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breath, application dominance, technology lifeline curve. The data points provided are only related to the companys focus related to Stem Cell Therapy market. Leading global Stem Cell Therapy market players and manufacturers are studied to give a brief idea about competitions.

The Following Manufacturers Are Covered In This Report:

Gilead,Novartis,Organogenesis,Vericel

Global Stem Cell Therapy Market Segmented By:

Product Type: Adult Stem Cells, Human Embryonic Stem Cells (hESC), Induced Pluripotent Stem Cells, Very Small Embryonic Like Stem Cells

Application: Regenerative Medicine, Drug Discovery and Development

Latest news and industry developments in terms of market expansions, acquisitions, growth strategies, joint ventures and collaborations, product launches, market expansions etc. are included in the report. The report focuses on the operation and their competitive landscape present within the market. Identification of numerous key players of the market will help the reader perceive the ways and collaborations that players will need to understand the competition within the global Stem Cell Therapy market.

Stem Cell Therapy Market report provides depth analysis of the market recent developments and comprehensive competitive landscape created by the COVID19/CORONA Virus pandemic. Stem Cell Therapy Market report is helpful for strategists, marketers and senior management, And Key Players in Stem Cell Therapy Industry.

Market Dynamics Of Stem Cell Therapy Market

Global Stem Cell Therapy market report has the best research offerings and the required critical information for looking new product trends or competitive analysis of an existing or emerging market. Companies can sharpen their competitive edge again and again with this business report. The report comprises of expert insights on global industries, products, company profiles, and market trends. Users can gain unlimited, company-wide access to a comprehensive catalog of industry-specific market research from this industry analysis report. The market report examines industries at a much higher level than an industry study.

Table of Content: Global Stem Cell Therapy Market Research Report

Chapter 1: Global Stem Cell Therapy Industry Overview

Chapter 2: Global Economic Impact on Stem Cell Therapy Market

Chapter 3: Global Market Size Competition by Industry Producers

Chapter 4: Global Productions, Revenue (Value), according to Regions

Chapter 5: Global Supplies (Production), Consumption, Export, Import, geographically

Chapter 6: Global Productions, Revenue (Value), Price Trend, Product Type

Chapter 7: Global Market Analysis, on the basis of Application

Chapter 8: Stem Cell Therapy Market Industry Value Chain

Chapter 9: Stem Cell Therapy Market Chain, Sourcing Strategy, and Downstream Buyers

Chapter 10: Strategies and key policies by Distributors/Suppliers/Traders

Chapter 11: Key Economic Indicators, by Market Vendors

Chapter 12: Market Effect Factors Analysis

Chapter 13: Global Stem Cell Therapy Market Forecast Period

Chapter 14: Future Of The Market

Chapter 15: Appendix

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Substantial research & development activities carry out by some players that comprises offering training to covering recent information on new technology, materials and techniques to innovative practice solutions, will complement the market growth is also explained. Frequent technological advances, superior portability, and ease of handling for Stem Cell Therapy are boosting adoption in home and alternate care settings as well. Furthermore, non-profit and government initiatives, and awareness programs, and an influx of funding for research studies have positively influenced developments within the industry.

Competitive Landscape and Stem Cell Therapy Market Share Analysis

The major players covered in the Stem Cell Therapy market report are Terumo Medical Corporation, Getinge AB., Medtronic, Edwards Lifesciences Corporation., Smiths Medical, Teleflex Incorporated., Johnson & Johnson Services, Inc., Abbott., Dispocard GmbH, Coloplast Corp., Boston Scientific Corporation or its affiliates., GENERAL ELECTRIC COMPANY, Astler Medicss., Tinomed Healthcare Private Limited., S N Medical Systems, Paras Healthcare, Elesonic Healthcare Private Limited., Ansh Healthcare., Omega Medsurge and Hi Tech Medi Systems. among other domestic and global players.

Global Stem Cell Therapy Market Scope And Market Size

By type, the Stem Cell Therapy market is segmented intoelectron beam computed tomography, nuclear Stem Cell Therapy, echocardiogram (ECG), cardiac catheterization, coronary arteriography, angiocardiography, and others.

By indication, the Stem Cell Therapy market is segmented into congenital heart diseases, coronary artery blockage, defects or injuries to the hearts fourprimary valves, blood clots within the heart, tumours in or on the heart, and others.

By end use, the Stem Cell Therapy market is segmented into hospitals and clinics, diagnostic centres, cardiac care centres, ambulatory centres and home care, academic institutes, and others.

Global Stem Cell Therapy Market: Regional Analysis

The research report includes specific segments by region (country), by company, by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2021 to 2027. Understanding the segments helps in identifying the importance of different factors that aid the market growth.

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Stem Cell Therapy Market Share, Size Global Forthcoming Developments, Updates, Leading Players,Future Growth, Business Prospects and Future...

Abecma (idecabtagene vicleucel ; ide-cel; formerly bb2121), a chimeric antigen receptor (CAR)-T cell therapy, led to improved survival in patients with multiple myeloma who have been treated with many other lines of therapy, according to updated results from the KarMMa trial presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.1

The favorable benefit risk profile of ide-cel, regardless of the number of prior lines of therapy, supports its role as a treatment option for heavily pretreated relapse refractory multiple myeloma, Dr. Larry D. Anderson, associate professor, UT Southwestern Medical Center, said during a presentation of the poster.

At the December 21, 2020, data cutoff, the average follow-up was 24.8 months (range, 1.7-33.6).

Overall response rate (ORR) the percentage of patients who responded to the treatment was 73% in the overall population, including a 33% complete response rate, where disease could not be detected (CRR; complete response [CR] or stringent complete response [sCR]), 20% with a very good partial response (VGPR), and 20% who had a partial response (PR). ORR rates were 50%, 69%, and 81%, respectively, across the 150, 300, and 450 million CAR T cell-dose arms, including CR/sCR rates of 25%, 29%, and 39%.

Of note, ORR did not vary by the number of prior lines of therapy received. For those who received three prior lines of therapy (a total of 15 patients), the ORR was 73%, including a CRR of 53% and VGPR of 20%, compared with an ORR of 73% in those who received four or more (112 patients) lines of therapy, including a CRR of 30%, VGPR of 23%, and PR of 20%.

Average duration of response (DOR; the time patients disease was stable or in remission after being treated) was 10.9 months, including 9.9 months for the 300 million CAR T cells-dose arm and 11.3 months for the 450 million CAR T cells-dose arm -dose arm. Median DOR was 21.5 months in patients who experienced a CR or sCR. Median DOR by response were 21.5 months among those who experienced a CR; 10.4 months for those with VGPR; and 4.5 months in those with PRs.

Moreover, the rate of event-free 24-month DOR appeared to be similar in patients who received three or four or more lines of therapy. For those who received three lines of prior therapy, median DOR was eight months, compared with 10.9 months in those who received four or more lines of therapy.

Average progression-free survival (PFS) meaning the length of time after treatment when the disease does not get worse was 8.6 months across all target doses, including 5.8 months for the 300 million CAR T cells-dose arm and 12.2 months for the 450 million CAR T cells-dose arm -dose arm. Similarly, average PFS was similar among those who previously received three lines of therapy, compared with four or more prior lines of therapy (8.6 months vs 8.9 months, respectively).

On average, it took patients about one month to respond to therapy and about 2.8 months to experience a CR.

Median overall survival (OS) was 24.8 months, including a median OS of 22.0 months in those who received three lines of prior therapy and 25.2 months in those who received four or more lines of prior therapy. Moreover, OS was 20 months or longer across several key high-risk subgroups, including those aged 65 or older (21.7 months), those with extramedullary disease (20.2 months), and those with triple refractory disease (21.7 months).

Regarding side effects, cytokine release syndrome (CRS; the effect of many inflammatory cytokine immune cells being release into the blood stream) and neurotoxicity (brain and/or nervous system damage) rates were similar, regardless of prior lines of therapy received, and were mostly low grade. In total, 85% and 18% of the overall population experienced at least 1 CRS or neurotoxicity event, respectively.

The safety profile of Abecma was consistent with long-term follow-up, with similar rates of infections and secondary primary malignancies, and no unexpected gene therapy related toxicities were observed. The most common grade 3 to 4 side effects in the overall population were neutropenia (89%), anemia (61%), thrombocytopenia (52%), leukopenia (39%), lymphopenia (27%) and infections (27%).

Long-term results from the KarMMA trial continue to demonstrate frequent, deep, and durable responses in heavily pretreated patients with [relapsed/refractory multiple myeloma], the study authors write in the poster. ORR, CRR, DOR and PFS were consistent with previous reports and patients received similar benefit regardless of the number of prior lines of therapy.

In his presentation, Anderson presented data on long-term efficacy and safety following treatment with Abecma in the pivotal phase 2 KarMMa trial (NCT03361748)-including overall data and by prior line of therapy that patients had received (three compared to four or more), since the FDA label is requiring at least four prior lines, and this study only required three, he added.

In total, 140 patients who had received at least three prior lines of therapy for multiple myeloma including an IMiD, a PI, and an anti-CD38 antibody and were refractory to their last treatment regimen, were enrolled in the study. However, only 128 patients received infusion with Abecma.

Patients were treated with Abecma across the target dose range of 150 (four patients), 300 (70 patients), and 450 (54 patients) million CAR T cells.

ORR served as the primary end point of the study. Secondary end points included CRR, safety, DOR, PFS, OS, pharmacokinetics, minimal residual disease, quality of life and health economics and outcomes research.

At the start of the trial, the average patient age was 61 years (range, 33-78) and patients had a median of six years (range, 1-18) since their diagnosis. A majority of the patients were male (59%), had high tumor burden (51%), B-cell maturation antigen (BCMA) expression 50% or more at screening (85%), ECOG performance status which measures how functional a patient is on a range of 1 (fully functioning) to 5 (dead) of 1 (53%), and Revised International Staging System disease stage of II (70%). Thirty-five percent of patients had high-risk features.2

The median number of prior therapies was six (range, 3-16) and 94% had previously undergone at least one autologous hematopoietic stem cell transplant (94%). Eighty-eight percent of patients required bridging therapy, a kind of pre-treatment before CAR-T cell thearpy. Eighty-nine percent of patients had double-refractory disease, 84% were triple-refractory and 26% were penta-refractory.

Patients who had received three prior lines of therapy had similar baseline characteristics, compared with those who received four or more prior lines, including differences in extramedullary disease, high-risk cytogenetics, prior refractoriness and time since the initial diagnosis to screening.

Patients with relapsed/refractory multiple myeloma previously exposed to immunomodulatory agents, protease inhibitors, and anti-CD38 antibodies have poor outcomes with subsequent therapy using previously approved regimens, with expected response rates in the 26% to 31% range, PFS in the two- to four-month range, and overall survival less than nine months, Anderson explained.

However, the BCMA-directed CAR-T cell therapy previously demonstrated favorable tolerability with deep, durable responses in patients who were heavily pretreated with relapsed/refractory multiple myeloma.As a result, the FDA approved the agent for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, representing the first BCMAdirected CAR T-cell therapy approved.

The study authors noted that is being explored in ongoing clinical trials, including the following:

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Abecma Continues to Improve Survival in Heavily Pretreated Patients With Multiple Myeloma - Curetoday.com

Michael Bishop, MD, a professor of medicine and director of Hematopoietic Stem Cell Transplantation Program at The University of Chicago Medicine, discussesthe different settings where chimeric antigen receptor (CAR) T-cell therapy are used.

Bishop thinks CAR T-cell therapy made a significant impact upon patient care. CAR T cells are indicated for 3 main groups of patients. The first is for non-Hodgkin lymphoma and for pediatric and young adult acute lymphoblastic leukemia (ALL), which has FDA-approved agents. More recent approvals have been for patients with mantle cell lymphoma. Physicians are waiting for what they expect to be the first indication for CAR T-cell therapy in multiple myeloma.

Starting with ALL for the pediatric population, CAR T cells have been a game changer, according to Bishop. These young patients have median overall survivals of less than 6 months, but the high response rates with CAR T are enabling them to potentially go on to an allogeneic stem cell transplant and in some cases, be free of disease.

In the non-Hodgkin lymphoma setting, there are now 3 products indicated for advanced B-cell non-Hodgkin lymphoma, which is significant for patients with totally refractory disease. There is this therapeutic option that is potentially curative. Bishop says investigators are seeing patients out to 5 years without any further therapy after receiving CAR T cells.

Excerpt from:
CAR T Cells Have Reshaped the Hematologic Cancer Landscape - Targeted Oncology