Prevail InfoWorks’ Post

𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭: 𝐏𝐟𝐢𝐳𝐞𝐫'𝐬 𝐀𝐝𝐜𝐞𝐭𝐫𝐢𝐬 𝐁𝐨𝐨𝐬𝐭𝐬 𝐒𝐮𝐫𝐯𝐢𝐯𝐚𝐥 𝐢𝐧 𝐃𝐢𝐟𝐟𝐮𝐬𝐞 𝐋𝐚𝐫𝐠𝐞 𝐁-𝐜𝐞𝐥𝐥 𝐋𝐲𝐦𝐩𝐡𝐨𝐦𝐚 𝐏𝐚𝐭𝐢𝐞𝐧𝐭𝐬 Pfizer Pfizer announced promising results from the Phase III ECHELON-3 study, showing that the antibody-drug conjugate Adcetris significantly improved survival rates in relapsed/refractory diffuse large B-cell lymphoma patients when combined with lenalidomide and rituximab. The study demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to the lenalidomide and rituximab plus placebo group. Adcetris also showed positive outcomes in secondary endpoints like overall response rate and progression-free survival. Safety profiles were consistent with previous findings, reassuring regarding Adcetris' tolerability. Roger Dansey Roger Dansey, Pfizer's Chief Development Officer of Oncology, emphasized the potential of Adcetris in addressing the unmet needs of patients, even those previously treated with CAR-T therapy. Originally developed by Seagen in collaboration with Takeda, Adcetris targets the CD30 surface protein, carrying a toxic payload that triggers cell death in malignant cells while sparing healthy ones. Pfizer acquired access to Adcetris through its acquisition of Seagen in March 2023. Adcetris, initially approved for Hodgkin lymphoma and rare systemic anaplastic large cell lymphoma, has gained additional approvals for various treatment settings and patient populations in these cancers. Pfizer is expanding Adcetris' applications in Hodgkin lymphoma, peripheral T-cell lymphoma, non-small cell lung cancer, and melanoma. This progress aligns with Pfizer's broader strategy of focusing on four cancer types, including hematologic malignancies. The company aims to bolster its biologics business, anticipating it to constitute 65% of its cancer franchise by 2030, with the Seagen acquisition playing a significant role in achieving this target. In addition to Seagen Seagen, Pfizer has partnered with Nona Biosciences to develop the mesothelin-targeting ADC HBM9033 in solid tumors, further enriching its oncology pipeline. #Adcetris #DLBCL #CancerSurvival #OncologyResearch #MedicalBreakthroughs #Pfizer #ClinicalTrials #HealthcareInnovation

Exciting developments in pancreatic cancer research revealed in Novotech's 2024 report! Over 2,000 clinical trials have been initiated globally since 2019, with North America and Asia-Pacific leading the charge. The drug development pipeline is robust, featuring 164 preclinical candidates and 233 in early-phase trials. 𝗞𝗲𝘆 𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗺𝗲𝗻𝘁𝘀 - 𝘙𝘈𝘚-𝘥𝘪𝘳𝘦𝘤𝘵𝘦𝘥 𝘵𝘩𝘦𝘳𝘢𝘱𝘪𝘦𝘴 𝘢𝘯𝘥 𝘪𝘮𝘮𝘶𝘯𝘰𝘵𝘩𝘦𝘳𝘢𝘱𝘪𝘦𝘴 𝘴𝘩𝘰𝘸 𝘱𝘳𝘰𝘮𝘪𝘴𝘦 - 𝘚𝘩𝘪𝘧𝘵 𝘵𝘰𝘸𝘢𝘳𝘥𝘴 𝘱𝘦𝘳𝘴𝘰𝘯𝘢𝘭𝘪𝘻𝘦𝘥 𝘮𝘦𝘥𝘪𝘤𝘪𝘯𝘦 𝘢𝘯𝘥 𝘵𝘢𝘳𝘨𝘦𝘵𝘦𝘥 𝘵𝘳𝘦𝘢𝘵𝘮𝘦𝘯𝘵𝘴 - 𝘎𝘳𝘰𝘸𝘪𝘯𝘨 𝘧𝘰𝘤𝘶𝘴 𝘰𝘯 𝘯𝘦𝘰𝘢𝘥𝘫𝘶𝘷𝘢𝘯𝘵 𝘤𝘩𝘦𝘮𝘰𝘵𝘩𝘦𝘳𝘢𝘱𝘺 North America and Asia-Pacific each contribute 38% and 37% of trials, respectively, with Europe following at 20%. The United States leads in North America, while China dominates in APAC. The surge in research activity marks a promising era for pancreatic cancer care, offering new hope to patients and their families. As we move towards more tailored and effective treatments, the future looks brighter for those affected by this challenging disease. CC: Business Wire

🌟 JUST OUT 🌟 in Cancers MDPI! Proud to have contributed to this special issue, “Research on Targeted Drugs in Cancer”. Targeted therapies comprised the largest proportion of #oncology drugs approved by the FDA over the past 25 years, and have become standard of care for the treatment of many cancers. However, despite the transformation of the therapeutic landscape, #dosefinding methodology originally developed for cytotoxic chemotherapy drugs has continued to be employed during #drugdevelopment. In recognition of the need to adapt the dose selection process for modern #cancer therapies and design alternative strategies, the #FDA has undertaken several initiatives in recent years (including the launch of #ProjectOptimus in 2021 and the release of draft guidance for industry on #doseoptimization of oncology drugs in 2023). In this paper, I present case studies for 6 different targeted cancer therapies, highlighting how dose-finding challenges have been managed to date by oncologists, sponsors, and regulators. This manuscript is dedicated to the memory of Anne Loeser (founder of the Patient-Centered Dosing Initiative), and to all the other patient advocates working tirelessly to improve outcomes and quality of life for those living with cancer. https://lnkd.in/eKhEf4WF

Pfizer's Lung Cancer Drug Expected to Exceed $1 Billion in Sales! Pfizer forecasts its lung cancer drug will surpass $1 billion in sales following impressive five-year survival data. This breakthrough treatment has shown significant efficacy, promising a brighter future for lung cancer patients. With these results, Pfizer strengthens its position in the oncology. Pfizer's Lung Cancer Drug Expected to Surpass $1 Billion in Sales! Pfizer predicts its lung cancer drug will exceed $1 billion in sales following impressive five-year survival data. This promising treatment has demonstrated significant efficacy, offering hope for lung cancer patients and solidifying Pfizer's position in the oncology market. With such groundbreaking results, Pfizer continues to lead in innovative cancer therapies. #Pfizer #LungCancer #Oncology #Pharmaceuticals #HealthcareInnovation #CancerTreatment #Recrutis Read more:

Clinical Trials Updated: The FDA grants priority review to Tagrisso for specific subtype of NSCLC Straight after ASCO, AstraZeneca's lung cancer drug Tagrisso has received priority review from the FDA for treating unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy. If approved, it would be the first targeted treatment for this condition. Tagrisso showed promising results in a clinical trial, reducing the risk of disease progression or death by 84% compared to placebo. Patients taking Tagrisso had a median progression-free survival of 39.1 months compared to 5.6 months for those on placebo. Safety data was consistent with Tagrisso's known profile. AstraZeneca is seeking a fast-track approval and hopes to establish Tagrisso as a new standard treatment for this type of NSCLC. https://lnkd.in/ewtsc7Xz #oncology #medicalaffairs #clinicaldevelopment #clinicaljobs #medicaljobs

FDA Advances Treatment Options for Colorectal Cancer with KRAZATI® and Cetuximab Combo The FDA has approved a supplemental new drug application for KRAZATI® (adagrasib) in combination with cetuximab for the treatment of KRAS G12C-mutated colorectal cancer (CRC). The decision is seen as significant for patients with limited treatment options. The FDA target date for a decision on the application is June 21, 2024. Bristol Myers Squibb, the company behind the therapy, is dedicated to innovative cancer treatments and hopes for a positive outcome from the FDA's review. The approval is based on the positive results of the KRYSTAL-1 study, which showed encouraging clinical activity. KRAZATI® is a targeted treatment for colorectal cancer and non-small cell lung cancers with the KRAS G12C mutation. Bristol Myers Squibb is committed to redefining cancer care through research and innovation. The healthcare community is hopeful that this combination therapy will provide a new option for those with advanced CRC. For more details please click the link! https://lnkd.in/dEy9E4Rx #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Cancer Therapy Breakthrough with Claudin 18.2-Targeted Drug Approved in European Union Astellas Pharma's Vyloy (zolbetuximab) has been approved by the European Commission for treating advanced or metastatic HER2-negative, Claudin 18.2-positive gastric and gastroesophageal junction cancers, following similar approvals in Japan and Great Britain. Vyloy, combined with chemotherapy, has shown significant survival benefits in the SPOTLIGHT and GLOW trials, extending life expectancy for patients. This targeted therapy could generate over $1 billion in sales, contingent on widespread adoption of Claudin 18.2 testing. Astellas Pharma acquired Vyloy through its purchase of Ganymed Robotics in 2016, and it is also being tested for Claudin 18.2-positive pancreatic cancer. For more details please click the link! https://lnkd.in/dZzvi3t5 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Carcinoma Treatment Advances: PT217 Receives FDA Orphan Drug Designation for Neuroendocrine Carcinoma Phanes Therapeutics, Inc. has received orphan drug designation from the FDA for its bispecific antibody, PT217, targeting neuroendocrine carcinoma, a highly aggressive cancer with limited treatment options. PT217 targets DLL3, overexpressed in NEC tumors, and CD47, blocking a cancer cell's "don't eat me" signal to enhance immune response. Previously granted ODD for small cell lung cancer and Fast Track designation for extensive-stage SCLC, PT217's development is further accelerated through a clinical supply agreement with Roche to study its combination with anti-PD-L1 therapy atezolizumab. The FDA's ODD provides Phanes Therapeutics, Inc. with financial incentives and potential market exclusivity, advancing the promise of PT217 in addressing the unmet needs of NEC and other aggressive cancers. For more details please click the link! https://lnkd.in/dMqZzkDJ #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

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 

Revolution Medicines has shared promising updates from their ongoing studies on RMC-6236, a novel pan-KRAS inhibitor, which targets various KRAS mutations found in pancreatic and other cancers💡 Their phase 1/1b clinical trial revealed that RMC-6236 shows significant anti-tumour activity and manageable side effects, such as rashes and gastrointestinal issues, in patients with advanced solid tumours. This drug targets multiple KRAS mutations, including KRAS G12D, most common in pancreatic cancer, and has shown encouraging results in reducing tumour sizes in preclinical models and early human trials. The trial aims to determine the optimal dosage for future studies, with the hope of providing a new effective treatment option for patients with KRAS-driven cancers. Read the full story here: https://lnkd.in/evQ27ijg. #CancerResearch #KRAS #DrugDevelopment