The Center for Advancing Innovation Inc.’s Post

Bowel Cancer Funding Proposal by Pharmac Marks Significant Step Forward PHARMAC has initiated a public consultation on its proposal to fund cetuximab (Erbitux) by Eli Lilly and Company for patients with left-sided metastatic bowel cancer, potentially benefiting around 180 patients in the first year. Cetuximab, a targeted therapy that inhibits the epidermal growth factor receptor, aims to prevent the growth and spread of bowel cancer in cases without specific genetic mutations. Geraldine MacGibbon, PHARMAC’s Director of Pharmaceuticals, emphasized the importance of this medicine in treating bowel cancer. The funding consideration follows a boost received in June 2024, allowing PHARMAC to progress with essential medicines. Additionally, PHARMAC is evaluating the potential funding of pembrolizumab, an immunotherapy for bowel cancer. For more details please click the link! https://lnkd.in/dy4i2zKr #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

FDA’s Endorsement: The Marvel of MRD Minimal Residual Disease (MRD) “Elevating MRD to the Forefront” and Revolutionizing Cancer Treatment Approaches The FDA’s Oncologic Drugs Advisory Committee’s recent meeting in April 2024 has cast a spotlight on Minimal Residual Disease (MRD), underscoring its critical role in the advancement of cancer therapies. Here’s how the FDA’s recognition is reshaping the future: 1. Multiple Myeloma: The FDA’s committee has officially recognized MRD as a valid endpoint for accelerated drug approvals. This pivotal decision by the FDA is a testament to MRD’s potential in changing the treatment paradigm for multiple myeloma. 2. Acute Lymphocytic Leukemia (ALL): MRD serves as a vital prognostic indicator, and the FDA’s stance influences treatment choices and regulatory approvals of new medications. It’s a significant step forward, with the FDA’s backing enhancing the credibility of MRD in clinical settings. 3. Chronic Lymphocytic Leukemia (CLL): The MRD status is integral to treatment planning, and the FDA’s consideration is crucial during the approval process of new treatments. The FDA’s involvement ensures that MRD remains a key factor in CLL therapy strategies. 4. Acute Myeloid Leukemia (AML): MRD is being considered by the FDA as a potential surrogate endpoint in trials, which could expedite the approval of innovative AML therapies. The FDA’s support could pave the way for quicker access to new treatments. These examples underscore the vital role of MRD as a clinical endpoint across various cancer types. It’s not just a measure; it’s a movement towards enhancing patient care and fast-tracking the introduction of innovative treatments. The FDA’s Oncologic Drugs Advisory Committee’s discussions and decisions highlight the indispensable role of MRD, now backed by the FDA’s authoritative support. It’s a monumental stride in enhancing patient care and introducing cutting-edge treatments more swiftly, all through the FDA’s visionary lens. For more details, please contact, [email protected] #oncology #oncolotrials #clinicaltrials #pharma #drugapproval #FDA #minimalresidualdisease #cancer #approval #aacr #esmo #ash Dr. Simone SeiterMoussa Ahmed AmerMou ChatterjeeAnshu Mittal Roy PhD (She/Her)Reena KhuranaKarnik RampalKriti ArnejaMolekule Consulting LLCDavid AldermanAmaninder Singh DhillonVikas SarangalRicha S.Nidhi DhingraYogesh VadepalliBruno LarvolAmit GuptaDr.Hamid Hasan Faridi, MD MBAMichele SpinettaRobert F. Siegmund, PhD MBASabih BeckDr. Timos PapagatsiasSalvador CarlucciDIWAKAR JHA, M.PHARM, M.B.A

BIG PHARMA AIMS TO SHORTEN MANUFACTURING TIMES FOR CAR-T BLOOD CANCER THERAPIES - List prices in the 1/2 million dollar range - Time means organs or life KEY TAKEAWAYS: "Big pharmaceutical companies that make personalized blood cancer treatments are working to cut the manufacturing turnaround time by as much as half in coming years, as they try to deliver them sooner in a patient's disease course." "These treatments known as CAR-T therapies are used for the sickest patients for whom standard treatments have failed." "Prices for the one-time treatment range from $400,000 to nearly $600,000, and analysts estimate they currently have profit margins of about 50%, so expanding the patient population is not insignificant." "Time to treatment, which was as long as 37 days when the first CAR-T therapy was launched in 2017 by Novartis, are now down to 14 days at Gilead. Improvements in automation and regulatory adjustments could help companies further trim that time." "To make the treatments, a patient's T cells are isolated, frozen and shipped to manufacturers. Once received, the cells are purified, modified and expanded to large enough numbers to treat the patient. They then go through quality control processes before being re-frozen and shipped back for infusion." "Novartis is aiming for 10 days or less in the U.S. for its next generation of treatments through its rapid manufacturing platform T-Charge. Its treatment, Kymriah, currently takes 3 to 4 weeks with a target of 22 days." "Since 2017, over 42,000 people globally have received CAR-T treatments. Six are approved in the U.S. for the treatment of blood cancers, including lymphomas and some forms of leukemia." #cart #bloodcancer #lymphoma #leukemia #bigpharma #pharma #pharmaceuticalindustry #cancer #fightingcancer #bristolmyerssquibb #jnj #novartis #gilead #advancedcancers #aggressivecancers #healthcare #stem #tcells #biotech #biotechadvancements #cancerresearch #nih #cancertherapies #pharmamanufacturing #advanceddrugs #advancedtherapies https://lnkd.in/eRN8E5Cn

𝐊𝐢𝐝𝐧𝐞𝐲 𝐂𝐚𝐧𝐜𝐞𝐫 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐃𝐫𝐮𝐠𝐬 𝐌𝐚𝐫𝐤𝐞𝐭 size to be valued at USD 6.3 billion by 2022 and is expected to grow at a compound annual growth rate (CAGR) of 5.4% during the forecast period. 𝐂𝐥𝐢𝐜𝐤 𝐇𝐞𝐫𝐞, 𝐓𝐨 𝐆𝐞𝐭 𝐅𝐫𝐞𝐞 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐩𝐨𝐫𝐭 https://lnkd.in/djRUjdaj Kidney cancer treatment drugs are at the forefront of oncology, offering hope and improved outcomes for patients battling this disease. Join us as we explore the dynamic Kidney Cancer Treatment Drugs Market, where innovation, research, and patient care intersect to redefine the landscape of kidney cancer therapy. 💪🌐 🔬 Advancing Treatment Options: The Kidney Cancer Treatment Drugs Market encompasses a diverse array of therapeutic agents, including targeted therapies, immunotherapies, and combination regimens. These drugs work to inhibit cancer growth, disrupt tumor progression, and bolster the immune system's ability to recognize and attack cancer cells, offering patients personalized and effective treatment options. 🌍 Global Impact: Kidney cancer affects individuals worldwide, and access to effective treatment is critical for improving patient outcomes and survival rates. The Kidney Cancer Treatment Drugs Market plays a pivotal role in addressing this global health challenge by ensuring that patients have access to innovative therapies, regardless of geographic location or socioeconomic status. 💡 Innovation and Collaboration: Ongoing research efforts and collaboration between academia, industry, and regulatory agencies drive innovation in the Kidney Cancer Treatment Drugs Market. Advances in drug development, biomarker identification, and combination therapy strategies are expanding treatment options and improving response rates, offering new hope to patients with advanced or refractory disease. 🚀 Future Directions: As our understanding of kidney cancer biology and treatment continues to evolve, the Kidney Cancer Treatment Drugs Market holds promise for further innovation and progress. Emerging trends such as precision medicine approaches, targeted drug delivery systems, and novel immunotherapeutic modalities are reshaping the future of kidney cancer therapy, paving the way for improved outcomes and quality of life for patients. #Company Amgen AstraZeneca Aveo Pharmaceuticals Pvt Ltd Exelixis Incyte Merck Group Roche Pfizer Bristol Myers Squibb Eisai US Novartis #Type • Angiogenesis Inhibitors • mTOR Inhibitors • Monoclonal Antibodies • Cytokine Immunotherapy (IL-2) #KidneyCancer #CancerTreatment #PrecisionMedicine #GlobalHealth #HopeAndHealing

Progression Free Survival & Overall Survival in Cancer Therapy Evaluation: FDA's Recent Thoughts & the Need for Methodological Development While writing a manuscript on the data and methodological challenges in estimating progression free survival (PFS) from #realworlddata in #cancerresearch, I was going through the BioSpace article on the #fda push for overall survival (OS) as outcome while evaluating efficacy & safety of #cancertherapies – thanks to Maddie Bender. The regulator’s pivot on OS for approval decisions going forward would of course have significant strategic & logistic impact on the design & conduct of outcome trials & the overall clinical development plan, particularly for the smaller pharma companies. This also brings new challenge in developing design & analysis methodologies, along with smarter approaches to data collection – in the context of robust estimation of PFS followed by OS assessment. The reason for raising this otherwise obvious point is – we know while PFS is acceptable “Accelerated Approval” designation, favorable OS analysis would be essential for confirmatory study for full approval – AND over the last decade, several  cancer outcome trials have reported efficiency based on PFS, but subsequently failed to establish OS benefit or showed adverse survival outcome.  For example, the Phase III BELLINI Trial in patients with relapsed/refractory multiple myeloma, evaluating efficacy & safety of venetoclax combined with bortezomib and dexamethasone, reported significantly positive PFS (HR CI: 0.44-0.90), but revealed completely oppositive unfavorable OS (HR CI: 1.04 – 3.95) [Lancet Oncol. 2020;21:1630-1642)]. While few attempts were made to evaluate the reason for such converse OS/PFS results from clinical explorations, the core aspects of confounder dynamics in the pathway between PFS and subsequent OS were never addressed. This brings a complex challenge in how we statistically evaluate the pathway between PFS and OS timeline. I believe, we need to develop methodologies along with revisiting the way we collect data of different domain, to (1) evaluate the potential #mediation effects of various observed / un-observed confounders in association with the treatment effect(s) post randomization AND post PFS estimation, (2) how #multimorbidity along with concomitant medications’ interactions during the course of follow-up play the role in differentiable PFS & OS. This is essential to ensure that an otherwise beneficial therapy is not denied for wrong reasons. Further challenges add while dealing with single-arm studies (#synthetictrial). Clearly this is an urgent unmet need requiring focused collaboration between academia, industry, and regulatory / payer. Jennifer Webster Josh Gagne Matthew Reynolds Anusha Kheir Anu Kalsekar Nathan Hubbard Robert Reynolds Maartje Smulders Christian Nguyen Puja Myles Cancer Research UK (CRUK) NICE - National Institute for Health and Care Excellence Asha Pillai MD Motiur Rahman

In the rapidly evolving area of cancer therapeutics, CAR-T has shown great promise and has changed the lives of many patients who have exhausted all other treatment options. This relatively new approach reprograms a patient’s own immune cells to target and destroy cancer cells, and has marked a tremendous step forward in personalised medicine. However, the FDA has issued a new warning about the possible risk of secondary cancers in patients who have been treated with this CAR-T therapy, highlighting the complexities and challenges that accompany medical innovation. Two main takeaways from a Market Access/HEOR perspective I have are: -Regulatory bodies, healthcare providers, and payers are likely to scrutinise these therapies even more closely going forward underscoring the critical need for experienced market access experts -The FDA’s recent mandate for extended 15-year follow-up studies on CAR-T therapies are a clear reminder of the importance of real-world evidence (RWE) and HEOR beyond the initial clinical trial and approval phases to ensure the highest level of patient safety For the full story, here is a recent article: https://lnkd.in/eijGj2mJ #HEOR #MarketAccess #oncology #RWE

📃Scientific paper: Development and Challenges of Diclofenac-Based Novel Therapeutics: Targeting Cancer and Complex Diseases Abstract: SIMPLE SUMMARY: Diclofenac is a widely used drug for its anti-inflammatory and pain alleviating properties. This review summarizes the current understanding about the drug diclofenac. The potential applications of diclofenac beyond its well-known anti-inflammatory properties for other diseases such as cancer are discussed, along with existing limitations. ABSTRACT: Diclofenac is a highly prescribed non-steroidal anti-inflammatory drug (NSAID) that relieves inflammation, pain, fever, and aches, used at different doses depending on clinical conditions. This drug inhibits cyclooxygenase-1 and cyclooxygenase-2 enzymes, which are responsible for the generation of prostaglandin synthesis. To improve current diclofenac-based therapies, we require new molecular systematic therapeutic approaches to reduce complex multifactorial effects. However, the critical challenge that appears with diclofenac and other drugs of the same class is their side effects, such as signs of stomach injuries, kidney problems, cardiovascular issues, hepatic issues, and diarrhea. In this article, we discuss why defining diclofenac-based mechanisms, pharmacological features, and its medicinal properties are needed to direct future drug development against neurodegeneration and imperfect ageing and to improve cancer therapy. In addition, we describe various advance molecular mechanisms and fundamental aspects linked with diclofenac which can strengthen and enable the better designing of new derivative... Continued on ES/IODE ➡️ https://etcse.fr/BQlC6 ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

More Pluses for GLP-1s 6/4/24 GLP-1 drugs have revolutionized the treatment of obesity demonstrating - in several RCTs - significant benefits for weight loss, diabetic control, as well as a reduction in strokes, heart attacks and cardiovascular-related deaths among people qualified to take them. Now, at the American Society of Clinical Oncology (ASCO), the largest cancer annual meeting in the world, several presentations are now suggesting 1) a reduction in the incidence of obesity related cancers like ovarian, liver, colorectal, pancreatic, bowel and breast cancer, and 2) a reduction in the recurrence of certain cancers. Whether their effects are due solely to the weight loss or associated with other mechanisms yet unknown - this is terrific news that will cement these group of drugs as the best sellers ever. While at present, only Wegovy, Ozempic (same Novo Nordisk drug, different indications), Mounjaro and Zepbound (same Eli Lilly drug, different indications) are available - numerous other agents are undergoing clinical trials. An oral agent (all others require injection) was recently proven to be very effective https://lnkd.in/eGDeaCck and it’s just a matter of time before we see this and other pill-form GLP-1s approved. #glp1 #cancer https://lnkd.in/exGBk9Mj

📢 FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy (GSK) ➤ Jemperli with carboplatin and paclitaxel, followed by single-agent Jemperli for adult patients with primary advanced or recurrent endometrial cancer (EC); previously approved in dMMR or MSI-H EC. ➤ Efficacy was evaluated in RUBY (NCT03981796), in 494 patients with primary advanced or recurrent EC. Patients were randomized (1:1) to either dostarlimab-gxly with carboplatin and paclitaxel, followed by dostarlimab-gxly, or placebo with carboplatin and paclitaxel, followed by placebo. ➤ In the overall population, a statistically significant OS improvement was observed with a median OS of 44.6 months vs. and 28.2 months (Hazard Ratio=0.69, 1-sided p-value=0.002). Median PFS in the overall population was 11.8 months vs. 7.9 months (HR=0.64; 1-sided p-value <0.0001). #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent https://lnkd.in/eV2P4yVJ

🚀 Breaking News Alert! 🚀 🎉 Exciting news for multiple myeloma patients! A groundbreaking CAR-T therapy has been approved for launch in China! 🎉 🔍On March 1st, 2024, CARsgen, a leading Chinese pharmaceutical company, proudly announced the official approval by the National Medical Products Administration (NMPA) of their innovative CAR-T cell immunotherapy product, Zevor-cel, targeting BCMA. This revolutionary treatment is specifically designed for adult patients with relapsed or refractory multiple myeloma who have undergone at least three prior lines of treatment, including a proteasome inhibitor and an immunomodulatory agent. 🌟 Zevor-cel marks CARsgen's debut commercial product, promising a new ray of hope for patients. While the price remains undisclosed, anticipation is high as it is expected to be competitive with its counterparts. Stay tuned as we eagerly await the reveal of its pricing strategy! 💪At the 2023 ASH Annual Meeting, Zevor-cel's impressive three-year follow-up data stole the spotlight, boasting a remarkable Overall Response Rate (ORR) of 100% and a median Progression-Free Survival (PFS) of 25.0 months. With a median Overall Survival (OS) yet to be reached, the two-year OS rate has already hit 100%, and the three-year OS rate stands at a remarkable 92.9%, underscoring its outstanding safety profile and offering renewed hope for patients battling relapsed or refractory multiple myeloma. 👍In terms of approved indications, it's worth noting that the current portfolio of domestic CAR-T therapies in China caters to various hematologic malignancies. While FOSUNKITE and JW Therapeutics target lymphomas, JUVENTAS focuses on leukemia. CARsgen and IASO Bio, however, have set their sights on multiple myeloma, aligning perfectly with the pressing medical needs of patients in this category. 👏Let's celebrate this remarkable milestone in the fight against multiple myeloma, as we continue to strive for better, more effective treatments to improve patients' lives worldwide! 🌍 #TogetherWeCanBeatCancer If you are interested in the latest cancer-fighting technologies and treatment methods in China, or if any of patients wish to learn more, our team is available to support and advise you and your patients at any time. Website：[https://www.medtourcn.com/] Whatsapp：+8613717959070 Email: [email protected] 🔍 #Zevorcel #CARsgen #MultipleMyeloma #CARTTherapy #MedicalBreakthrough #NMPAApproval #HopeForPatients #HealthcareInnovation #CancerTreatment #MedicalAdvancement