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7 episodes with afinitor
2 episodes with afinitor
7 episodes with afinitor
2 episodes with afinitor
3 episodes with afinitor
4 episodes with afinitor
2 episodes with afinitor
The FDA is certainly staying busy as 2023 comes to a close, approving three treatments for patients with cancer last week alone. Additionally, exciting study findings were released regarding a cancer vaccine for the treatment of melanoma. FDA Approves Iwilfin for High-Risk Neuroblastoma in Adults and Children The FDA approved has Iwilfin (eflornithine) for the treatment of adult and pediatric patients with high-risk neuroblastoma who have shown at least a partial response to a previous multiagent modality therapy, which includes anti-GD2 immunotherapy. Notably, the FDA reported that this drug is the first approval of a therapy used to reduce the risk of relapse in children with high-risk neuroblastoma. Neuroblastoma, as the National Cancer Institute explained on its website, is a cancer of immature nerve cells that most typically occurs in children, and often begins in the adrenal glands. The FDA said the major efficacy outcome measure behind the approval was event-free survival (EFS; time after treatment when cancer does not come back or worsen; disease progression), while other notable findings included overall survival (OS; length of time from diagnosis or start of treatment when a patient is still alive). FDA Approves Welireg for Advanced Kidney Cancer Subtype The FDA approved Welireg ((beluztifan) for patients with advanced renal cell carcinoma (RCC) who have been previously treated with a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The approval was based on findings from the LITESPARK-005 trial. Trial findings presented earlier this year at the European Society of Medical Oncology Annual Congress (ESMO) showed that at a median follow-up of 18.4 months, patients treated with Welireg experienced objective response rates (patients whose disease responded partially or completely to treatment) of 21.9%, compared with 3.5% among patients treated with Afinitor (everolimus), and 12-month progression-free survival (PFS; the time a patient lives without their disease spreading or worsening) rates were 33.7% on Welireg versus 17.6% with Afinitor, and 18-month PFS rates were 22.5% and 9%, respectively. FDA Approves Padcev-Keytruda Combo in Advanced Bladder Cancer The FDA has additionally approved Padcev (enfortumab vedotin-ejfv) plus Ketruda (pembrolizumab) for patients with locally advanced or metastatic bladder cancer. Alongside this, the FDA previously granted an accelerated approval for this patient population who are unable to be treated with cisplatin-containing chemotherapy. In the recent EV-302/KN-A39 trial, both OS and PFS showed significant improvements among the Padcev plus Keytruda group of patients, as the median overall survival for these patients was 31.5 months, while a cohort treated with chemotherapy experienced a median OS of 16.1 months. Regarding progression-free survival, the median was 12.5 months for the Padcev-Keytruda combination group and 6.3 months in the chemotherapy group. Cancer Vaccine Plus Keytruda Reduces Risk of Recurrence or Death in Melanoma Patients with advanced-stage melanoma continue to experience reduced risk of recurrence or death following treatment with a combination of mRNA vaccine mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), and Keytruda, according to recent study findings. The mRNA-4157 (V940) and Keytruda combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 52% when compared with treatment with Keytruda alone in patients with stage 3 or 4 melanoma with high risk of recurrence following complete resection, as determined by the phase 2b KEYNOTE-942/mRNA-4157-P201 study, according to a news release from drug manufacturers Moderna and Merck. The latest findings, from a median planned follow-up of approximately three years, build on previously announced primarily analysis data from a median planned follow-up of approximately two years which showed that the combination reduced the risk of recurrence or death by 44% and the risk of distance metastasis or death by 65% when compared with Keytruda alone. Based on the trial's findings, the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to the combination for the post-surgical treatment of patients with high-risk melanoma earlier this year. Moderna and Merck have also announced the phase 3 INTerpath-001 (V940-001) clinical trial to evaluate the combination as an adjuvant treatment for patients with resected, high-risk stage 3B to 4 melanoma, which is currently enrolling participants, as well as a phase 3 trial for the treatment of patients with non-small cell lung cancer treated with the combination regimen. For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.
Last week, the European Society of Medical Oncology (EMSO) held their annual Congress in Madrid. The conference brought together cancer researchers from around the globe, who presented their clinical trial data — some of which has the potential to change the way cancers are treated. For example, the Food and Drug Administration (FDA) approves therapies based on study data that proves that the regimen in question is safe, effective and superior to what is currently being used in that indication. While we don't have a crystal ball and can't say for sure if and when the FDA will approve a regimen, we can reflect on data presented at ESMO that we know the agency is considering and give our audience some potential oncology approvals that they should look out for. Welireg Outperforms Afinitor in Advanced Clear Cell Kidney Cancer The FDA is currently reviewing the phase 3 LIFESPARK-005 trial, comparing Welireg to Afinitor for patients with pretreated advanced clear cell renal carcinoma. Data from LIFESPARK-005, which were presented at the ESMO Congress, showed that Welireg outperformed Afinitor when it came to progression-free survival (that's the time a patient lives after treatment without their disease worsening) and objective response rate (which describes the percentage of patients whose disease shrinks or disappears from treatment). However, there was no significant difference in overall survival (time from treatment unitl death of any cause) observed between the Welireg and Afinitor groups. The FDA is set to make their decision on this Welireg indication by Jan. 17, 2024. Keytruda Plus Chemoradiotherapy Bests Standard of Care in Advanced Cervical Cancer Also on the FDA's docket for review is findings from the phase 3 KEYNOTE-A18 trial, investigating the addition of Keytruda to external beam radiotherapy — known as EBRT — and concurrent chemotherapy and followed by brachytherapy, for the treatment of patients with newly diagnosed, high-risk locally advanced cervical cancer. Study findings, which were presented at the ESMO Congress, showed that adding the immunotherapy agent to the regimen improved progression-free survival, overall survival and response rates. One expert, Dr. Bradley J. Monk, even commented, “This is a celebration for patients because we're challenging a treatment paradigm that has stood for more than two decades.” The FDA stated that it plans to make its approval decision of Keytruda in this indication by Jan. 20, 2024. Data Supporting FDA Approval of Pre- and Postsurgical Keytruda for Advanced Lung Cancer Presented Days before ESMO, the FDA also approved Keytruda for the pre- and postsurgical treatment of patients with resectable (able to be removed via surgery) stage 2, 3A or 3B non-small cell lung cancer (NSCLC). The approval is based off findings from the phase 3 KEYNOTE-671 trial, which compared treatment with presurgical Keytruda plus chemotherapy followed by postsurgical Keytruda against presurgical placebo plus chemotherapy, followed by placebo. According to the FDA, overall survival (the time from treatment until death of any cause) was not reached in the Keytruda group, meaning not enough patients in that cohort had died to determine an average time until death. The median overall survival time was 52.4 months in the placebo group. Study findings presented at EMSO showed improvements in event-free survival (the time a patient lives without any disease-related occurrences, such as a recurrence/relapse or death), which was also not yet reached among patients in the Keytruda arm of the study. For more news on cancer updates, research and education, don't forget to subscribe to CURE®'s newsletters here.
In this episode, Simi speaks with Gaurav Shah, Co-Founder and CEO of Rocket Pharmaceuticals, a company developing first-in-class gene-modified cell therapies to treat rare diseases. Gaurav is also a Grammy Award Winner.Prior to his role as founding CEO, Gaurav was a Global Program Head in the Cell & Gene Therapies Unit at Novartis, where he had strategic oversight of 12 functions and helped spearhead pivotal trials for patients with leukemia and lymphoma. His earlier roles at Novartis span being a Global Clinical Program Head for CART-19 and Biosimilars, and lead physician for Afinitor in several global oncology submissions. Gaurav started his career in industry at ImClone/Eli Lilly as a Medical Director overseeing oncology trials.Gaurav graduated from Harvard College with a degree in Behavioral Neuroscience. He received his M.D. from Columbia University, completed his internal medicine residency at Brigham and Women's Hospital, and hematology/oncology fellowship training at Memorial-Sloan Kettering. After receiving board certification in medical oncology, he served as an Adjunct Assistant Professor of Oncology at Columbia.To find balance, Gaurav also has long explored his passion for Indian classical music. In 2019, he and his wife were Grammy nominees and in 2022, they won the Grammy for Best Children's Album, for their album entitled A Colorful World. In this conversation, Simi explore's multidimensional career from medicine to music.For more episodes, visit us at southasiantrailblazers.com. Subscribe to our newsletter to get new episodes and updates on our latest events in your inbox. Follow us @southasiantrailblazers on Instagram, LinkedIn, Facebook, and Youtube.
Dr. Bing Yuan is an entrepreneur and a seasoned business executive in business development and licensing (BD&L), marketing and new product strategy. He has made significant contributions to 13 approved global oncology drugs at various stages of product life cycle, including blockbusters such as Keytruda and Glivec. Before founding OnCusp, he was Chief Strategy and Business Officer at CStone Pharmaceuticals. As a senior executive from the beginning, he helped to build the company from scratch to successful IPO and a fully integrated biopharma. At CStone, he established and managed over 10 departments, such as BD&L, public relations, R&D project management and commercial organization. He successfully reached close to 10 strategic partnerships with Pfizer, Bayer, Blueprint, Agios, EQRx, etc. Before joining CStone in November 2016, he spent 22 years in the USA. He was Executive Director and Global Lead of Oncology BD&L at Merck (MSD), Global Head of Life Cycle Strategy and Executive Director at Novartis Oncology, Global Oncology Marketing Lead at Eisai, and Product Manager at Thermo-Fisher. He successfully led or contributed to over 40 M&A, licensing and Keytruda clinical collaboration deals. As a core member of the global project team (GPT), he played a key role in designing development strategy for 5 oncology drugs. He used to lead Glivec and Afinitor brand life cycle strategy, and participated in global launch of Zykadia in ALK+ lung cancer. Dr. Yuan holds a Ph.D. in Molecular Biology from Columbia University, an MBA from Cornell University and B.S. of Biochemistry from Nanjing University. In this episode of Behind Biotech with Bing, we discussed: Bing's professional journey from China to the US and back to China Catalysts behind the striking growth of the Chinese Biotech industry starting in 2015 Pioneering new models of global outlicensing of Chinese Biotech with OnCusp Therapeutics
My guest Briana Johnson is 21 years old and lives in Scottsdale Arizona. She'll be graduating this month from Grand Canyon University with a bachelors degree in marketing. Over the past few months, she had the opportunity to be a national Junior Leader for the TS Alliance and represent Arizona advocating in DC this past March. She was diagnosed with Tuberous Sclerosis Complex at age 3, initially with skin symptoms. Brianna discusses the challenges related to transitioning to adult care, kidney issues and surgery, and how the Mayo Clinic created a clinic based on their experience with Brianna! We touch on her go-to coping mechanisms, humor and sarcasm, transitioning to college and managing her medical needs, her experience as an advocate representing Arizona at the March on Capitol Hill and the exciting new Facebook group she helped create for young adults with TSC to be a safe space for other young adults with TSC (age 16-24) to share their stories, to make connections and discuss aspects of dealing with the disease and provide peer support to one another, and to share resources. "Our goal is to make sure no young adult with TSC has to face this fight alone" Thanks Briana! (music credit: www.woodywoodworth.com "peace like a river")
My guest Briana Johnson is 21 years old and lives in Scottsdale Arizona. She'll be graduating this month from Grand Canyon University with a bachelors degree in marketing. Over the past few months, she had the opportunity to be a national Junior Leader for the TS Alliance and represent Arizona advocating in DC this past March. She was diagnosed with Tuberous Sclerosis Complex at age 3, initially with skin symptoms. Brianna discusses the challenges related to transitioning to adult care, kidney issues and surgery, and how the Mayo Clinic created a clinic based on their experience with Brianna! We touch on her go-to coping mechanisms, humor and sarcasm, transitioning to college and managing her medical needs, her experience as an advocate representing Arizona at the March on Capitol Hill and the exciting new Facebook group she helped create for young adults with TSC to be a safe space for other young adults with TSC (age 16-24) to share their stories, to make connections and discuss aspects of dealing with the disease and provide peer support to one another, and to share resources. "Our goal is to make sure no young adult with TSC has to face this fight alone" Thanks Briana! (music credit: www.woodywoodworth.com "peace like a river")
Debora Moritz is a Grassroots Advocate, Chair of TS Alliance of Arizona, Member of the Government Relations Committee, and most importantly "just Griffin's mom trying to make things better for him and few other folks along the way." From diagnosis of TSC at 5 months, vigabatrin failure, ACTH treatment success, early frustrations with lack of knowledge, Debora kept asking questions everywhere she went with Griffin. Leaving no stone unturned in terms of trying anything and everything that she could discover that may help stop the seizures, her perseverance led to Griffin's getting chosen to participate in a clinical trial of an investigational medication in to shrink the SEGAs, and as a result, a significant reduction occurred in the size of his tumors. The exceptional results of this trial led to the rapid FDA approval of Afinitor, the first drug designated to specifically treat SEGAs associated with tuberous sclerosis complex (TSC) in 2010. We discuss Debora's government advocacy in the evolution of the March on Capitol Hill, growing from a handful of people to well over 100 volunteers last year and getting 200 Democratic & Republican Representatives signing on to support TSCRP funding. We hit some of the highlights from successes over the years, working with other volunteers, making personal connections and continually asking the tough questions that demand better answers are part of Debora's methods of grassroots advocacy. In her own words, " We cannot wait for others to keep the momentum going for us; we must do so together. "We can change lives. And we can get to a place where no one has to suffer from the devastating effects of tuberous sclerosis complex, but it takes action." (music credit: https://www.purple-planet.com/)
Debora Moritz is a Grassroots Advocate, Chair of TS Alliance of Arizona, Member of the Government Relations Committee, and most importantly "just Griffin's mom trying to make things better for him and few other folks along the way." From diagnosis of TSC at 5 months, vigabatrin failure, ACTH treatment success, early frustrations with lack of knowledge, Debora kept asking questions everywhere she went with Griffin. Leaving no stone unturned in terms of trying anything and everything that she could discover that may help stop the seizures, her perseverance led to Griffin's getting chosen to participate in a clinical trial of an investigational medication in to shrink the SEGAs, and as a result, a significant reduction occurred in the size of his tumors. The exceptional results of this trial led to the rapid FDA approval of Afinitor, the first drug designated to specifically treat SEGAs associated with tuberous sclerosis complex (TSC) in 2010. We discuss Debora's government advocacy in the evolution of the March on Capitol Hill, growing from a handful of people to well over 100 volunteers last year and getting 200 Democratic & Republican Representatives signing on to support TSCRP funding. We hit some of the highlights from successes over the years, working with other volunteers, making personal connections and continually asking the tough questions that demand better answers are part of Debora's methods of grassroots advocacy. In her own words, " We cannot wait for others to keep the momentum going for us; we must do so together. "We can change lives. And we can get to a place where no one has to suffer from the devastating effects of tuberous sclerosis complex, but it takes action." (music credit: https://www.purple-planet.com/)
Dr. Guru Sonpavde highlights the top research news in immunotherapy for kidney cancer from the ASCO 2014 Annual Meeting.
Dr. Guru Sonpavde highlights the top research news in immunotherapy for kidney cancer from the ASCO 2014 Annual Meeting.
Dr. Guru Sonpavde highlights the top research news in immunotherapy for kidney cancer from the ASCO 2014 Annual Meeting.
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Cometriq (cabozantinib) is already approved for thyroid cancer and is showing promise for late stage kidney cancer.
Dr. Lauren Harshman explains what PD1 (an immune T-cell) and PDL1 (a protein on the PD1 T-cell) are and how new drugs impact them to fight kidney cancer.
Dr. Lauren Harshman explains what PD1 (an immune T-cell) and PDL1 (a protein on the PD1 T-cell) are and how new drugs impact them to fight kidney cancer.
Dr. Lauren Harshman explains what PD1 (an immune T-cell) and PDL1 (a protein on the PD1 T-cell) are and how new drugs impact them to fight kidney cancer.
Drugs in early stage clinical trials seem to show benefit for non-clear cell kidney cancer, but more trials must take place and patients are desperately needed to enroll in them.
Drugs in early stage clinical trials seem to show benefit for non-clear cell kidney cancer, but more trials must take place and patients are desperately needed to enroll in them.
Drugs in early stage clinical trials seem to show benefit for non-clear cell kidney cancer, but more trials must take place and patients are desperately needed to enroll in them.
Dr. Guru Sonpavde discusses what he does when he first begins treating a patient recently diagnosed with late stage kidney cancer.
Dr. Guru Sonpavde discusses what he does when he first begins treating a patient recently diagnosed with late stage kidney cancer.
Dr. Guru Sonpavde discusses what he does when he first begins treating a patient recently diagnosed with late stage kidney cancer.
Patients are responding very well to the next generation of immunotherapy drugs currently in clinical trials to treat kidney cancer.
Patients are responding very well to the next generation of immunotherapy drugs currently in clinical trials to treat kidney cancer.
Patients are responding very well to the next generation of immunotherapy drugs currently in clinical trials to treat kidney cancer.
Results from recent clinical trials looking into PD1 inhibitors of kidney cancer are giving patients and doctors reasons to be hopeful.
Results from recent clinical trials looking into PD1 inhibitors of kidney cancer are giving patients and doctors reasons to be hopeful.
Results from recent clinical trials looking into PD1 inhibitors of kidney cancer are giving patients and doctors reasons to be hopeful.
Today in FirstWord:
Today in FirstWord:
Stepping up health care: New report
Stepping up health care: New report
Today in FirstWord:
New treatment for advanced breast cancer patients improves quality of life.
New treatment for advanced breast cancer patients improves quality of life.
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