Dr. Leona Saunders’ Post

EU access to oncology medicines lags behind in the Netherlands In the study, funded by the European Fair Pricing Network (EFPN), time-to-patient access was assessed at the hospital level, including those products that entered markets initially under early access programmes. - https://lnkd.in/dSbVUtrQ #pharma #oncology #medicineaccess #marketaccess

The cancer drug shortage has been a critical issue, with significant impacts on patient care and clinical trials. Crystal Denlinger, MD, FACP, CEO of the National Comprehensive Cancer Network® (NCCN®), highlights the primary causes, including manufacturing issues, supply chain disruptions, and regulatory delays. Watch here! #CancerCare #DrugShortage #Oncology #ClinicalTrials #NCCN #Pharmaceuticals

🧬 Celltrion has received approval from the US FDA for IND application for a phase 3 clinical trial of CT-P51, its biosimilar to Keytruda (pembrolizumab). 💉 With this IND approval, Celltrion plans to initiate a global phase 3 clinical trial involving 606 patients with metastatic non-small cell lung cancer (NSCLC). 🌍 The trial aims to demonstrate that CT-P51 is as effective as Keytruda, the original drug.

We're pleased to announce a significant milestone: the FDA's clearance for our next-generation selective RET inhibitor, EP0031/A400, to enter Phase 2 clinical development. This potential treatment for RET-altered tumors has shown promising efficacy in patients with NSCLC, thyroid, and other solid tumors. EP0031/A400's clinical data will be presented at American Society of Clinical Oncology (ASCO) 2024 in Chicago on June 3rd, showcasing its potential to transform the treatment landscape for patients worldwide. This drug, jointly developed by Ellipses Pharma and Sichuan Kelun Pharmaceutical Co., Ltd. has already received Orphan Drug Designation and Fast Track Designation from the FDA. Our Chief Executive Officer, Dr Rajan Jethwa MA MRCS expressed optimism about this milestone, highlighting our commitment to developing EP0031 as a potential next-generation treatment for RET-altered NSCLC and other cancers. As we move forward, our Global Head of Drug Development and Chief Medical Officer, Professor Tobias Arkenau underscores the significance of EP0031/A400 in addressing the unmet medical needs of patients with RET fusion-positive NSCLC. This achievement represents our dedication to advancing innovative cancer treatments and bringing hope to patients and their families worldwide. Follow us for further updates. https://lnkd.in/eyj7dkyz #ClinicalTrials #CancerResearch #EllipsesPharma #EP0031

🌟 Exciting Breakthroughs in Blood Cancer Treatment 🌟 As a product launch strategist in the pharmaceutical realm, witnessing the strides made by Servier Pharmaceuticals with Tibsovo's FDA approvals is nothing short of inspirational. From its initial nod in 2018 for relapsed or refractory AML to the recent green light for treating IDH1-mutated MDS, Tibsovo is a game-changer. 🏆 Big kudos to Servier for their relentless pursuit of innovation and patient care. Their ability to navigate the complexities of product launch and regulatory approval is a testament to their commitment to transforming lives. It's a privilege to support such groundbreaking work that offers new hope to patients fighting blood cancers. 1A Servier Pharmaceuticals drug acquired as part of a $1.8 billion deal has won an additional FDA approval as a treatment for a rare type of blood cancer carrying a specific mutation. https://wllw.co/ghQxQvZe9y #InnovationInOncology #ProductLaunchExcellence #pharmaceuticalproctlaunchsucces #Lynndonaldsonconnecta

📢 FDA converts 2021 accelerated approval of tepotinib (EMD Serono, Inc.) in MET exon 14 NSCLC ➤ Initial AA granted on ORR & DOR in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study ➤ The conversion to traditional approval was based on an additional 161 patients and an added 28 months of follow-up time to assess DOR ➤ ORR was 57% with 40% of responders having a DOR ≥12 months; among 149 previously treated patients, ORR was 45% (95% CI: 37, 53), with 36% of responders having a DOR ≥12 months #oncology #biotech #biotechnology #regulatoryaffairs #pharma #drugdevelopment #oncologytrials #oncologyresearch #cancer #oncology #regulatoryintelligence #regulatoryprecedent #nsclc https://lnkd.in/emKGTXpb

Merck & Co Inc (NYSE:MRK) announced Friday that its drug Keytruda has been backed by the European Medicines Agency’s Committee for Medicinal Products in Human Use (CHMP) for use in certain patients with biliary tract cancer. The CHMP’s recommendation to approve Keytruda in combination with gemcitabine and cisplatin for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma will now be reviewed by the European Commission for marketing authorization in the European Union, with a final decision expected by the year-end. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has shown an overall survival benefit compared to chemotherapy alone, to these patients in the European Union,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research laboratories. More at #Proactive #ProactiveInvestors #NYSE #MRK #Merk http://ow.ly/HeTI1050Xew

As we come to a close on #GlobalBiosimilarsWeek, check out our 3-part series exploring how oncology #biosmilars are being used in different global markets. Part 1 focuses on the clinical benefits, price changes, and uptake associated with #oncology biosimilars in China. Part 2 covers a cost-effectiveness analysis regarding oncology biosimilars in France, and part 3 analyzes whether clinical efficacy studies can predict EMA regulatory approvals. 🌍💉🥼 Check out Part 1 here: https://lnkd.in/e97J4xMX

📢 Queries Raised During Oncology Business Pipeline Meetings at the European Medicines Agency: A 5- Year Retrospective Analysis 📍The study shows how the business pipeline meeting platform represents a valuable tool for the developers of medicinal products and provide insight on key challenges in the development of oncology medicines. #ema #medicinalproducts #oncology #businesspipelinemeetingplatform

“Amgen secure widely anticipated FDA clearance for watershed lung cancer treatment” American biopharmaceutical giant Amgen have received FDA approval for their breakthrough small-cell lung cancer (SCLC) treatment, Imdelltra. This release will represent a first of its kind treatment alternative for patients suffering from SCLC, a particularly aggressive and difficult to diagnose strain of lung cancer that affects roughly 30,000 people in the US every year. This drug acts by signalling T-Cells to attack and kill certain tumour expressions, with clinical trial results showing tumour reduction in 40% of exposed patients. CEO and co-founder of GO2 for Lung Cancer, Laurie Fenton, had the following to say around the approval: "After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available. Today's FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease”. For more bi-weekly updates on the biggest happenings in the pharmaceutical industry, sign up to our newsletter in the link below! 🔬 #lifesciences #pharmaceuticals #biotechnology #underthemicroscope