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Posted On: 08/13/2024 3:48:48 PM
Post# of 148870
In my opinion, this is how the richest man in LA treats bladder cancer or other cancers -
ImmunityBio, Inc., IBTX -
In May 2024, the National Comprehensive Cancer Network (NCCN) added Anktiva to its guidelines for bladder cancer. Anktiva has a list price of $35,800 per dose, and ImmunityBio offers a copay program for eligible patients that provides Anktiva at $100 per dose, with a maximum benefit of $25,000
ImmunityBio’s ANKTIVA® Now Covered By More Than a Dozen Insurance Plans Representing Over 100 Million Lives Within Months of FDA Approval
Business Wire
10–13 minutes
ANKTIVA® reaches U.S. commercial and Medicare insurance coverage milestone within three months of FDA approval
Global expansion of commercial and clinical bladder cancer programs
Filing process initiated with European Medicines Agency (EMA) for regulatory approval of ANKTIVA in European Union countries
Global filing for BCG naïve trial initiated (QUILT-2.005) in India
ANKTIVA Non-Small Cell Lung Cancer (NSCLC) FDA meeting held in June 2024
CULVER CITY, Calif., August 12, 2024--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), today announced significant progress in market access, making ANKTIVA® (nogapendekin alfa inbakicept-pmln) widely available to patients through both commercial and government insurance programs. The company also announced plans to expand its bladder cancer program globally, notably in the European Union and India.
Commercial Update
ImmunityBio’s commercial team continues to execute on key market access initiatives, which have resulted in more than 100 million medical lives being covered by medical reimbursement policies that include eligibility for ANKTIVA reimbursement since the therapeutic became available and was added to the National Comprehensive Cancer Network (NCCN) guidelines in May 2024. The company anticipates that it will achieve agreements to extend the number of lives covered in the coming months, and is currently working with the top insurance plans and academic institutions in the U.S. to increase ANKTIVA accessibility. This availability and reimbursement together have enabled the first patients to begin receiving ANKTIVA within eight weeks of FDA approval and resulted in initial product revenue for the company primarily in the last 30 days of Q2.
"We are encouraged by the keen interest that physicians are showing in ANKTIVA as a treatment option for their patients with non-muscle invasive bladder cancer with carcinoma in situ (CIS), as well as by our conversations with payers as we see them adding our approved product into their policies," said Richard Adcock, President and CEO of ImmunityBio. "Our team continues to focus on streamlining the processes for bringing this specialty medication to more qualified patients. We are acutely aware that with cancer, every day matters."
European Regulatory Filing
ImmunityBio has begun the filing process for obtaining regulatory approval for ANKTIVA in the European Union (EU) and United Kingdom. The filing will include 30 countries, including 27 in the EU and three in the European Economic Area. The company anticipates completing the submission of the initial EMA filing in Q4 2024.
BCG Naïve Trial Global Expansion
ImmunityBio continues to add U.S. sites to the BCG naïve trial (QUILT-2.005) and enroll patients in the study. Further, the company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India and the necessary medicines have been successfully imported into the country for use in the trial. Additionally, the company plans to submit an application to the South Africa regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.
NSCLC FDA Meeting Results
On April 25, 2024, the company announced positive overall survival results of ANKTIVA combined with checkpoint inhibitors in NSCLC from the completed QUILT 3.055 trial. In that trial, the median overall survival was almost double that of standard-of-care chemotherapy in second- and third-line NSCLC patients whose cancer did not respond to checkpoint inhibitors, with or without chemotherapy. After a meeting with the FDA in June 2024 to discuss a path to a registration filing for ANKTIVA plus checkpoint inhibitors for this indication, the company is preparing additional study information responsive to the Agency’s input on a NSCLC pivotal trial. ImmunityBio plans a subsequent meeting with the FDA to discuss the study end points for a potential approval on various timelines.
"The approval of ANKTIVA with a first-in-class mechanism of action of activating natural killer cells, CD8 killer T cells, and memory T cells, marks the beginning of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "The quest of developing a cancer vaccine by orchestrating the innate and adaptive immune system has begun and we look forward to developing ANKTIVA as the foundation across multiple tumor types and even in subjects without cancer but at high risk such as in Lynch syndrome."
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit: www.immunitybio.com
ImmunityBio, Inc., IBTX -
In May 2024, the National Comprehensive Cancer Network (NCCN) added Anktiva to its guidelines for bladder cancer. Anktiva has a list price of $35,800 per dose, and ImmunityBio offers a copay program for eligible patients that provides Anktiva at $100 per dose, with a maximum benefit of $25,000
ImmunityBio’s ANKTIVA® Now Covered By More Than a Dozen Insurance Plans Representing Over 100 Million Lives Within Months of FDA Approval
Business Wire
10–13 minutes
ANKTIVA® reaches U.S. commercial and Medicare insurance coverage milestone within three months of FDA approval
Global expansion of commercial and clinical bladder cancer programs
Filing process initiated with European Medicines Agency (EMA) for regulatory approval of ANKTIVA in European Union countries
Global filing for BCG naïve trial initiated (QUILT-2.005) in India
ANKTIVA Non-Small Cell Lung Cancer (NSCLC) FDA meeting held in June 2024
CULVER CITY, Calif., August 12, 2024--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), today announced significant progress in market access, making ANKTIVA® (nogapendekin alfa inbakicept-pmln) widely available to patients through both commercial and government insurance programs. The company also announced plans to expand its bladder cancer program globally, notably in the European Union and India.
Commercial Update
ImmunityBio’s commercial team continues to execute on key market access initiatives, which have resulted in more than 100 million medical lives being covered by medical reimbursement policies that include eligibility for ANKTIVA reimbursement since the therapeutic became available and was added to the National Comprehensive Cancer Network (NCCN) guidelines in May 2024. The company anticipates that it will achieve agreements to extend the number of lives covered in the coming months, and is currently working with the top insurance plans and academic institutions in the U.S. to increase ANKTIVA accessibility. This availability and reimbursement together have enabled the first patients to begin receiving ANKTIVA within eight weeks of FDA approval and resulted in initial product revenue for the company primarily in the last 30 days of Q2.
"We are encouraged by the keen interest that physicians are showing in ANKTIVA as a treatment option for their patients with non-muscle invasive bladder cancer with carcinoma in situ (CIS), as well as by our conversations with payers as we see them adding our approved product into their policies," said Richard Adcock, President and CEO of ImmunityBio. "Our team continues to focus on streamlining the processes for bringing this specialty medication to more qualified patients. We are acutely aware that with cancer, every day matters."
European Regulatory Filing
ImmunityBio has begun the filing process for obtaining regulatory approval for ANKTIVA in the European Union (EU) and United Kingdom. The filing will include 30 countries, including 27 in the EU and three in the European Economic Area. The company anticipates completing the submission of the initial EMA filing in Q4 2024.
BCG Naïve Trial Global Expansion
ImmunityBio continues to add U.S. sites to the BCG naïve trial (QUILT-2.005) and enroll patients in the study. Further, the company has received regulatory approval to begin patient enrollment in QUILT-2.005 in India and the necessary medicines have been successfully imported into the country for use in the trial. Additionally, the company plans to submit an application to the South Africa regulatory authorities in Q3 2024 to initiate the QUILT-2.005 trial in that country.
NSCLC FDA Meeting Results
On April 25, 2024, the company announced positive overall survival results of ANKTIVA combined with checkpoint inhibitors in NSCLC from the completed QUILT 3.055 trial. In that trial, the median overall survival was almost double that of standard-of-care chemotherapy in second- and third-line NSCLC patients whose cancer did not respond to checkpoint inhibitors, with or without chemotherapy. After a meeting with the FDA in June 2024 to discuss a path to a registration filing for ANKTIVA plus checkpoint inhibitors for this indication, the company is preparing additional study information responsive to the Agency’s input on a NSCLC pivotal trial. ImmunityBio plans a subsequent meeting with the FDA to discuss the study end points for a potential approval on various timelines.
"The approval of ANKTIVA with a first-in-class mechanism of action of activating natural killer cells, CD8 killer T cells, and memory T cells, marks the beginning of a next-generation immunotherapy beyond checkpoint inhibitors," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "The quest of developing a cancer vaccine by orchestrating the innate and adaptive immune system has begun and we look forward to developing ANKTIVA as the foundation across multiple tumor types and even in subjects without cancer but at high risk such as in Lynch syndrome."
About ImmunityBio
ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit: www.immunitybio.com
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