Breyanzi (lisocabtagene maraleucel) from Juno/Bristol Myers Squibb achieved FDA approval on February 5, 2021 for the treatment of adults with relapsed/refractory large B-cell lymphomas. It is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy and is made up of autologous T cells that are genetically modified to produce the CAR protein. This then activates T cells to kill CD19-expressing normal and lymphoma cells in cancer patients. Breyanzi is now the third CAR-T therapy approved after Yescarta and Kymriah which entered the market in 2017.
According to Peter Marks, who is the director of the FDA’s Center for Biologics Evaluation and Research, this is‘another milestone in the rapidly progressing field of gene therapy’ as it provides an ‘additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes”.
Breyanzi, like the other CAR-T therapies, is a personalized immunotherapeutic that is generated from a patient’s own T-cells which are then genetically modified in vitro, and then infused back into the patient. In a multicenter clinical trial in over 250 relapsed/refractory large B-cell lymphoma adult patients, a complete remission rate of 54% was seen in the Breyanzi treated group. Several severe side effects are noted however, including cytokine release syndrome (CRS) and subsequent neurologic toxicities, serious infections, low blood counts and an immunocompromised status in patients. Therefore, the FDA approved Breyanzi with a risk evaluation and mitigation strategy (REMS), and health professionals that administer and prescribe the drug must be able to identify and manage CRS symptoms.
CAR-T Immunotherapies Address Significant Unmet Needs
The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? Some patients do indeed show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as CRS and neurotoxicity. The main players within the CAR-T market are Juno Therapeutics and Kite Pharma, and now BMS. The market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies. Since the FDA approved Kymriah and Yescarta in 2017, the market has expanded and strengthened.
Kelly Scientific forecasts that the CAR T therapy industry will become more streamlined in the near future, with faster manufacturing times as advances in technologies take hold. Clinical trials are continuing to provide more evidence that this immunotherapy is robust, and with the approval of Breyanzi in 2021, the industry will strengthen further.
These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis and BMS taking stage will push CAR T therapy ahead. Manufacturing challenges are one of the most discussed points on CAR T therapy at present. Advice from regulators mainly indicates as to having an effective product and robust manufacturing process in place and to communicate effectively with regulators as early as possible. Relying on a single manufacturing plant is also a significant risk, as most stakeholders are entering unchartered waters if reviews halt progress. Overall, the CAR T space is well on its way to overcoming challenges such as toxicities, streamlining manufacturing, increasing cell persistence and efficiency and subsequently understanding the mechanisms behind relapse.
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This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials. Kelly Scientific analysis indicates that the global regenerative medicine market was worth $35.3 billion in 2019 and will grow to over $124 billion by 2025, with a CAGR of 23.3% between this time frame. This report describes the evolution of such a huge market in 15 chapters supported by over 350 tables and figures in over 700 pages.
- An overview of regenerative medicine that includes: stem cells, allogenic and autogenic cells, umbilical cord blood banking, tissue engineering and CAR T therapies.
- Global regenerative medicine market, global breakdown, application breakdown and leading market players
- Detailed account of the stem cell industry market by geography, indication and company profiles
- Profiles, marketed/pipeline products, financial analysis and business strategy of the major companies in this space
- Focus on current trends, business environment, pipeline products, clinical trials, and future market forecast for regenerative medicine
- Insight into the challenges faced by stakeholders, particularly about the success failure ratios in developing regenerative medicine drugs and therapies.
- Insight into the biobanking industry globally and its impact on the overall market
- Description and data for the prevalence of disease types that are addressed by regenerative medicine, stem cells, tissue engineering and CAR-T therapies
- Financial market forecast through 2025 with CAGR values of all market segments outlined in the objective
- SWOT analysis of the global market
- Geographical analysis and challenges within key topographies including the USA, Japan, South Korea, China and Europe
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