AJMC - The American Journal of Managed Care’s 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

Oncology Drug Development - Navigating The Timeframe Dynamics Oncology trials can be fast, just 5 months longer than others. Smart tactics like targeted therapies and FDA pathways can speed things up. Non-oncology trials are measured due to crowded markets and regulations. Here's a Strategy: explore rare diseases, innovate trial designs. Read more on the Pharma Leaders Blog. #OncologyTrials #TimeTravel #FluxCapacitor

Through Project Optimus, the FDA is taking aim at revising dose-ranging studies for oncology drug development. The future of oncology is here! While our team published this article in 2022 when the project was introduced, we've made recent revisions, offering new recommendations and insights. If you are developing an oncology drug, we recommend you collaborate with the FDA and to review the January 2023 guidance shared in this content – it is full of insights and a strong step in a positive direction for patients and industry. https://hubs.la/Q02lYyPQ0 Questions about your oncology development plan and your regulatory strategy? Connect with Halloran. We’re ready when you are. #Oncology #OncologyResearch #DrugDevelopment #ProjectOptimus #FDA #ClinicalTrials

Today the FDA approved updated labeling for temozolomide (Temodar, Merck) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the second drug to receive a labeling update under this pilot program. The first drug that received approval under Project Renewal was capecitabine (Xeloda). #FDA, #drugdevelopment #Regulatoryscience #cancer

FDA's Oncology Center of Excellence has a "Real Time Oncology Review" that will accelerate the review process for oncology related marketing applications. Sponsors need to submit topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application. Submissions to be considered for the RTOR program should meet the following criteria: 1. Drugs likely to demonstrate substantial improvements over available therapy or meeting criteria for Expedited Programs. 2. Straightforward study designs. 3. Endpoints that can be easily interpreted (e.g., overall survival, response rates, etc.). This program supported approvals of 20, 9 and 4 original applications in 2020, 2021 and 2022 respectively. More information can be found here: https://lnkd.in/g_ACXT8G # FDA # Regulatoryaffairs #oncology

In our recent blog, Dr Katherine Bowen, Senior Director of Regulatory Affairs, and Dr Julie Warner, Vice President of Regulatory Affairs, explore the ever-evolving world of oncology drug development and the regulatory landscape in the US and EU. Read more: https://lnkd.in/eb2-NtXB #oncology #regulatoryaffairs #US #Europe #oncologydrugdevelopment

NCCN Guidelines Favor Cancer Drugs Granted Regular Approval This cross-sectional study found that cancer drug indications with accelerated approval had lower evidence and treatment preference ratings in the NCCN guidelines than indications with regular approval from the FDA; however, even among drugs with regular approval, most indications were supported by lower-level evidence. Indications with accelerated approval were significantly less likely than indications with regular approval to receive category 1 recommendations — 3% and 47%, respectively (P <.001) — or to be categorized as preferred — 40% and 58%, respectively (P =.008). #cancertreatment #oncologyresearch #cancercare #oncologyguidelines #oncologyapprovals

It is remarkable that in less than a week, the Food and Drug Administration has granted approval to two novel B-call maturation antigen (BCMA) drugs for Multiple Myeloma. On August 9, the FDA granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Today Augsut 14th, the FDA granted approval to Pfizer's Elrexfio, or elranatamab for MM patients for have received at least four lines of therapy. Both drugs are bispecific antibodies, delivered under the skin and engaging T cells to target BCMA-expressing cancer cells. Consult the FDA Approval alerts link for details for Oncology (Cancer) / Hematologic Malignancies Approval Notifications | FDA for details on the drugs. These approvals should bring new hopes and therapeutic options to Multiple Myeloma patients. #fdaapproval #antibodies #multiplemyeloma

There is no debate the price-setting provisions in the Inflation Reduction Act (IRA) will lead to fewer new medicines, and the ones that are likely to be hit first — and hit hardest — are the ones developing the next generation of breakthrough cancer medicines. This policy — the “pill penalty” — will further discourage companies from moving forward with the types of advances highlighted at American Society of Clinical Oncology (ASCO) and removes incentives for companies to continue investing in research as products mature. That’s exactly the opposite of what patients want and need. #inflationreductionact #pharmaceuticals #oncologyresearch #Sodakbionews https://lnkd.in/gmXGxrtu

Exciting developments in the biopharmaceutical industry – Race Oncology Ltd witnessed an 11% stock increase as the FDA awards Rare Pediatric Disease Designation to their drug, RC220 bisantrene. This marks a significant leap forward in pediatric acute myeloid leukemia treatment options.🎗️ Such designations are pivotal in expediting the development of treatments for life-threatening diseases with limited prevalence. The potential of obtaining a Priority Review Voucher upon marketing approval could mean game-changing outcomes for patients and investors alike. R&D in pediatric care gets an impactful boost, providing hope for effective remedies where they're deeply needed. 💡 CEO Dr Daniel Tillett and CMO Dr Michelle Rashford underline the designation's value, emphasizing speedier reviews and rewarding incentives to tackle complex pediatric diseases. Investors, take note: Race Oncology's trajectory is one to watch! 🚀 #RaceOncology #FDAApproval #Biopharmaceuticals #StockMarket #PediatricCancer #MedicalInnovation #AML #HealthcareInvesting Read more about this stride in medical science here: https://lnkd.in/gQbaskeF