NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies.EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
DLBCL is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, comprising of an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.1,2,3,4,5
"DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances."
AbbVie is committed to transforming standards of care across blood cancers and advancing a dynamic cancer research and treatment pipeline. EPKINLY marks the third approved blood cancer treatment available as part of AbbVie's growing oncology portfolio, aswe strive to make a remarkable impact for people living with cancer.
"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," said Tycel Philips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. "Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."
"The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication," said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.
Highlights of the Phase 1/2 EPCORE™ NHL-1 clinical trial supporting the approval:
In the expansion cohort of the EPCORE NHL-1 trial, 148 patients with CD20+ DLBCL were enrolled, 86 percent of which were diagnosed with DLBCL NOS, including 27 percent with DLBCL transformed from indolent lymphoma, and 14 percent with HGBL. The median number of prior therapies was three (range: 2 to 11), with 30 percent receiving two prior therapies, 30 percent receiving three prior therapies, and 40 percent receiving four or more prior therapies. Eighteen percent had prior autologous hematopoietic stem cell transplantation (HSCT), and 39 percent had prior chimeric antigen receptor (CAR)T-cell therapy. Eighty-two percent of patients had disease refractory to last therapy and 29 percent of patients were refractory to CAR T-cell therapy.
EPKINLY delivered an overall response rate of 61 percent, a complete response rate of 38 percent and median duration of response of 15.6 months in heavily pretreated R/R DLBCL patients.
The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Warnings and precautions include infections, cytopenias, and embryo-fetal toxicity. The most common (≥ 20 percent) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions,pyrexia, abdominal pain, nausea, and diarrhea. Please see additional Important Safety Information, below.
About EPKINLYTM (epcoritamab-bysp)
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer. EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.
EPKINLY is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards target cell types. It is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of CD20+ cells.5,6,7
AbbVie and Genmab are evaluating EPKINLY as a monotherapy, and in combination, across multiple lines of therapy in a range of hematologic malignancies. This includes an ongoing Phase 3, open-label, randomized controlled trial evaluating EPKINLY as a monotherapy in patients with R/R DLBCL (NCT: 04628494) and two Phase 3, open-label, randomized controlled trials evaluating EPKINLY combination regimens in patients with newly diagnosed DLBCL (NCT: 05660967) and R/R follicular lymphoma (NCT: 05409066). The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year.
IMPORTANT SAFETY INFORMATION
Important Warnings—EPKINLY can cause serious side effects, including:
Cytokine Release Syndrome (CRS). CRS is common during treatment with EPKINLY and can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop symptoms of CRS, including fever of 100.4°F (38°C) or higher, dizziness or lightheadedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), or problems with balance and movement, such as trouble walking.
Due to the risk of CRS, you will receive EPKINLY on a "step-up" dosing schedule. The step-up dosing schedule is when you receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any symptoms of neurologic problems, including trouble speaking or writing, confusion and disorientation, drowsiness, tiredness or lack of energy, muscle weakness, shaking (tremors), seizures, or memory loss.
Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.
Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems.
EPKINLY can also cause other serious side effects, including:
Infections. EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
Low blood cell counts. Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cell counts (neutropenia), which can increase your risk for infection; low red blood cell counts (anemia), which can cause tiredness and shortness of breath; and low platelet counts (thrombocytopenia), which can cause bruising or bleeding problems.
Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:
have an infection.
are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY.
are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.
These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.
You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatchor to GenmabUS, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see Medication Guide, including Important Warnings.
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visithttp://www.abbvie.com/oncologyand ourBlood Cancer Press Kit page.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
1 Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.
2 What is Lymphoma. Lymphoma Coalition. https://lymphomacoalition.org/what-is-lymphoma/. Accessed April 24, 2023.
3 Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma. 2022;63(1):54-63.
4 Crump M, Neelapu SS, Farooq U, et al. Blood. 2017;130(16):1800-1808.
5 Chao MP. Cancer Manag Res. 2013;5:251-269.
6 Engelberts PJ, Hiemstra IH, de Jong B, et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625
7 Rafiq S, Butchar JP, Cheney C, et al. "Comparative Assessment of Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage Properties." J. Immunol. 2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
8 Singh V, Gupta D, Almasan A."Development of Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels on Cell Surface: Looking to Improve Immunotherapy Response." J Cancer Sci Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373
SOURCE AbbVie
FAQs
Is epcoritamab FDA approved? ›
FDA Approves Epcoritamab for Relapsed/Refractory DLBCL and High-Grade B-Cell Lymphoma. Patients with relapsed/refractory diffuse large B-cell lymphoma can now receive epcoritamab following the FDA's approval of the agent.
What bispecific antibody is approved by the FDA? ›On 22 December 2022, the US Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb, Genentech's full-length bispecific monoclonal antibody that targets the B cell–specific surface antigen CD20 and the T cell surface protein CD3, for adults with relapsed or refractory follicular lymphoma.
What are bispecific antibodies for lymphoma? ›Bispecific antibodies (BsAb) are a novel class of off-the-shelf T-cell redirecting drugs and are among the most promising immunotherapeutics for lymphoma today. BsAb may target various cell-surface antigens and exist in different formats.
Is glofitamab approved by the FDA? ›The FDA has accepted Genentech's biologics license application (BLA) and granted priority review for glofitamab to treat adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
What are the side effects of epcoritamab? ›- Cytokine Release Syndrome (CRS) CRS can occur. ...
- Neurologic Toxicity including ICANS. ...
- Infection and Low White Blood Cell Count (Leukopenia/Neutropenia) ...
- Diarrhea. ...
- Injection Site Reactions. ...
- Muscle or Joint Pain/Aches. ...
- Nausea and/or Vomiting. ...
- Fatigue.
FDA has approved Epkinly (epcoritamab-bysp) injection for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma after two or more lines of systemic therapy.
How much does bispecific antibody cost? ›In the clinical trial, the average patient was treated for 9 to 10 months. Based on this, the total cost of therapy ranges between a list price of $355,000-$395,000, the spokesperson said.
What is the difference between monoclonal and bispecific antibody? ›Monoclonal antibodies have two arms that each recognize the same target antigen. In contrast, bispecific antibodies are engineered hybrid molecules with two unique binding domains, each of which recognizes a unique target.
How many bispecific antibodies have been approved? ›Currently, there are nine bispecific antibodies approved worldwide, more than 180 BsAbs are in preclinical development, and over 50 BsAbs have been investigated in clinical trials.
What is the new antibody for lymphoma? ›The U.S. Food and Drug Administration (FDA) today granted approval of mosunetuzumab (Lunsumio®) for the treatment of adults with advanced follicular lymphoma. This is the first bispecific antibody, a type of immunotherapy, approved to treat any type of non-Hodgkin lymphoma.
What is the new antibody treatment for lymphoma? ›
Brentuximab and rituximab are a type of monoclonal antibody. They target specific proteins on lymphoma cells and help the immune system to pick out these cells and kill them. Because of the way they work they are sometimes called a targeted immunotherapy drug.
Why are bispecific antibodies better? ›These bispecific antibodies treat cancer by engaging the tumor-specific antigen CD20 and the CD3 antigen on T cells. "Bispecifics allows us to overcome the limitations of the immune system failing at its job: recognize and eliminate cancer cells,” says lymphoma specialist Loretta Nastoupil, M.D.
What is the brand name for glofitamab? ›Glofitamab, sold under the brand name Columvi is a bispecific monoclonal antibody used for the treatment of diffuse large B-cell lymphoma.
What is the new FDA approved antiviral? ›Remdesivir is the only antiviral drug that is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19.
Is FDA granted priority review to Roche's bispecific antibody glofitamab? ›The US Food and Drug Administration (FDA) has granted priority review for glofitamab, Roche's CD20xCD3 T-cell engaging bispecific antibody. The decision for the FDA priority review of glofitamab is for adults with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
When will epcoritamab be approved? ›On May 19, 2023, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab US, Inc.) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines ...
What class of drug is epcoritamab? ›| Monoclonal antibody | |
|---|---|
| Drug class | Antineoplastic |
| ATC code | None |
| Legal status | |
| Legal status | US : ℞-only |
A bispecific monoclonal antibody, with potential immunomodulating and antineoplastic activities.
What is the most difficult lymphoma to treat? ›Blastic NK cell lymphoma
This very rare type of T cell lymphoma only affects a few people each year. It usually affects adults. Blastic NK cell lymphoma tends to grow very quickly and can be difficult to treat. It can start almost anywhere in the body.
Hodgkin lymphoma is one of the most curable forms of cancer. After treatment is complete, your care team will develop a survivorship plan that minimizes long-term side effects of treatment. Those risks include infertility, secondary cancers or toxicities to vital organs such as the heart and lungs.
Which lymphoma is easier to cure? ›
Hodgkin lymphoma is considered one of the most treatable cancers, with more than 90 percent of patients surviving more than five years. Most patients with Hodgkin lymphoma live long and healthy lives following successful treatment.
How much does a gram of monoclonal antibody cost? ›The cost of goods to produce mAbs is dependent on the amount of mAb(s) per dose, the regimen (how many doses are needed) as well as the demand and production scale. Current production costs are estimated at $US 95-200 per gram.
When was the first bispecific antibody approved? ›In addition, research on a different class of antibody therapeutics, bispecific antibodies, has recently led to outstanding clinical results, and the first approval of the bispecific antibody catumaxomab, a T cell retargeting agent that was approved in the European Union in April 2009.
Can bispecific antibodies be monoclonal? ›A bispecific monoclonal antibody (BsMAb, BsAb) is an artificial protein that can simultaneously bind to two different types of antigen or two different epitopes on the same antigen. Naturally occurring antibodies typically only target one antigen.
Are monoclonal antibodies better than vaccine? ›Another difference is that antibodies produced naturally by your body in response to a vaccine can last for a long time, but these laboratory-made monoclonal antibodies usually only last for a few months, thus requiring people to get multiple infusions or injections on a regular schedule.
What are the three monoclonal antibody treatments? ›- ACTEMRA® (tocilizumab) (EUA issued June, 24 2021, latest update December 21, 2022). ...
- Bamlanivimab (EUA issued November 9, 2020, EUA revoked April 16, 2021). ...
- Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021, latest update January 24, 2022).
Monoclonal antibody therapies are used to treat or prevent an increasingly broad range of diseases, including various cancers, auto-immune and metabolic diseases. Some examples include Crohn's disease, asthma, rheumatoid arthritis and bladder cancer.
Did Biden limit monoclonal antibodies? ›The Food and Drug Administration (FDA) on Monday significantly restricted the use of a pair of monoclonal antibody treatments for COVID-19 because they are ineffective against the omicron variant.
What was the first monoclonal antibody approved? ›The first licenced monoclonal antibody was Orthoclone OKT3 (muromonab-CD3) which was approved in 1986 for use in preventing kidney transplant rejection [7].
Has the US developed a monoclonal antibodies? ›Palivizumab was the first antiviral monoclonal antibody approved by the US Food and Drug Administration (FDA) for prophylaxis of respiratory syncytial virus (RSV) in high-risk infants.
What kills lymphoma cells? ›
Chemotherapy is one of the main tools used to treat lymphoma. Chemotherapy medications are chemicals that kill lymphoma cells. They may be taken as pills or infusions into your veins.
What is the newest treatment for non-Hodgkin's lymphoma? ›A drug called ibrutinib (Imbruvica) has been developed to shut down that pathway. It is being used and tested in a number of ways: In the last several years, the drug has been approved for the treatment of small lymphocytic lymphoma and Waldenstrom macroglobulinemia, both indolent non-Hodgkin lymphomas.
What is the new monoclonal antibody for lupus? ›What is Benlysta? Benlysta is a human monoclonal antibody that was approved for the treatment of lupus in adults by the U.S. Food and Drug Administration (FDA) in 2011 and for lupus nephritis in adults in 2020. Benlysta was approved to treat lupus in children in 2019 and lupus nephritis in children in 2022.
How long is your immune system compromised after rituximab? ›Complete B cell-depletion for up to 48 weeks can be observed after a single dose of rituximab (5).
What is the success rate of immunotherapy for lymphoma? ›Treatment with chemo-immunotherapy for aggressive lymphomas such as diffuse large B-cell (DLBCL) obtains complete responses in 75–80% of patients.
Can lymphoma be cured with immunotherapy? ›Immunotherapies help fight cancer by enhancing or replacing parts of the immune response so that it can do its job and eliminate cancer cells from the body. Immunotherapy agents have been approved for the treatment of many types of cancer, including lymphoma.
What are the side effects of bispecific antibodies? ›Side effects of bispecific antibodies include cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, cytopenias, and infections, which can be managed by supportive care.
What is an example of a bispecific antibody? ›Mode of action of therapeutic bispecific antibodies (bsAbs). (a) Recruiting of T cells or natural killer (NK) cells to tumors is achieved by entities that bind to tumor cell surface antigens as well as to immune cells. Examples are TrioMabs (catumaxomab), BiTEs (blinatumomab), DARTs, and TandAbs.
What are the problems with bispecific antibody production? ›There are mainly two problems that must be solved to produce the desired IgG-like bispecific antibody—the heterodimerization of two different heavy chains and the discrimination between the two light-chain/heavy-chain interactions [142].
What drugs are approved for T-cell lymphoma? ›GDP (gemcitabine, dexamethasone, and cisplatin) Lenalidomide (Revlimid) Nivolumab (Opdivo) Panobinostat (Farydak)
What are the bispecific antibodies in glofitamab? ›
Glofitamab is a CD20xCD3 T-cell-engaging, bispecific antibody capable of recruiting T cells to tumor cells. We have summarized several of the latest reports on glofitamab use in B cell lymphoma therapy from the 2022 ASH Annual Meeting (ASH2022).
What class of drug is glofitamab? ›Classes: Antineoplastics, Anti-CD20 Monoclonal Antibodies.
Who should not take Paxlovid? ›Paxlovid is not suitable for some people. Tell your doctor before starting to take this medicine if you: are pregnant, trying to get pregnant or breastfeeding.
What is the newest antiviral for COVID? ›Remdesivir is an antiviral medication administered by an intravenous (IV) method that works against the COVID-19 virus by directly stopping the viral replication process. It interferes with one of the key enzymes the virus needs to replicate and stops the infection from progressing.
What are the two new oral antivirals for COVID-19? ›Molnupiravir and nirmatrelvir plus ritonavir have been licensed by the Medicines and Healthcare products Regulatory Agency for the treatment of covid-19 in adults.
Which bispecific antibody is approved by FDA? ›On 22 December 2022, the US Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb, Genentech's full-length bispecific monoclonal antibody that targets the B cell–specific surface antigen CD20 and the T cell surface protein CD3, for adults with relapsed or refractory follicular lymphoma.
Which bispecific antibodies are FDA approved? ›EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Which nanobody drug is FDA approved? ›Caplacizumab, a von Willebrand factor–directed antibody fragment, is the first targeted, nanobody-based therapy that inhibits blood clots formation to receive approval for adults with acquired TTP. The FDA granted caplacizumab an orphan drug designation.
When was amivantamab FDA approved? ›The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal–epithelial transition receptor, on May 21, 2021, for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with ...
Are there any FDA approved stem cell therapies? ›Currently, the only stem cell treatments approved by the Food and Drug Administration (FDA) are products that treat certain cancers and disorders of the blood and immune system.
What gene therapy is FDA approved? ›
| Name | Type |
|---|---|
| BREYANZI (2021) | Cell (autologous, modified) |
| CARVYKTI (2022) | Cell (autologous, modified) |
| CLEVECORD (2016) | Cell (allogeneic) |
| DUCORD (2012) | Cell (allogeneic) |
On September 20, 2021, the FDA approved tisotumab vedotin-tftv (brand name Tivdak), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
What kind of drug is amivantamab? ›Amivantamab-vmjw injection is in a class of medications called bispecific antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.
Who is amivantamab made by? ›The applicant for this medicinal product is Janssen-Cilag International N.V. Amivantamab was approved for medical use in the European Union in December 2021.
What is the difference between amivantamab and mobocertinib? ›The key difference [between them] is that mobocertinib is an oral agent while amivantamab is an infusional agent, and… some patients prefer oral therapies [because they minimize] visits to the doctor's office.
Why does insurance not pay for stem cell therapy? ›However, stem cell therapy still qualifies as an experimental medical procedure, so health insurance carriers will not cover it. If you are interested in stem cell therapy but are concerned about its ineligibility for coverage under your current health insurance plan, don't worry.
What is the best stem cell clinic in the world? ›- Stem Cell Institute, Panama. Enquire Now. Stem Cell Institute is one of the best stem cell hospitals in the world. ...
- GIOSTAR. Enquire Now. GIOSTAR is among the leading stem cell therapy providers in the world. ...
- Mayo Clinic. Enquire Now. ...
- OHSU Knight Cancer Institute.
The most common FDA-approved stem cell-based therapy is hematopoietic stem cell transplantation, which treats blood cancers like leukemia. Stem cells can also be regenerative therapy for severe skin burns and seriously damaged corneas.
What is the most recently approved gene therapy? ›Zynteglo®, approved by the FDA in August 2022, delivers a functioning copy of the beta-globin gene into patients' blood stem cells.
What is the $3 million dollar prescription? ›$3.5-Million Hemophilia Gene Therapy Is World's Most Expensive Drug. On 22 November, the US Food and Drug Administration (FDA) approved the first gene therapy for the genetic blood-clotting disorder haemophilia B—a one-time treatment that costs US$3.5 million.
What is the most expensive drug approved by the FDA? ›
The Food and Drug Administration approved late last year CSL Behring's hemophilia B gene therapy Hemgenix, a one-off infusion that costs $3.5 million a dose, making it the world's most expensive drug.
What are the side effects of Tivdak? ›- Decreased red blood cell and white blood cell counts.
- Tiredness.
- Nausea.
- Numbness or tingling in your hands or feet, or muscle weakness (peripheral neuropathy)
- Hair loss (alopecia)
- Nosebleed (epistaxis)
- Eye problems (conjunctival disorders)
- Bleeding (hemorrhage)
...
Intravenous Powder For Injection.
| Quantity | Per unit | Price |
|---|---|---|
| 1 | $6,698.16 | $6,698.16 |
Tivdak is a medicine that consists of two parts that are connected: an antibody that attaches to a molecule called tissue factor on the surface of cancer cells, and a chemotherapy drug called monomethyl auristatin E (MMAE).