|
The PCDI, an MBC patient-led initiative recently brought under the Alliance umbrella, encourages physicians and patients to jointly discuss dosages upon treatment initiation and throughout treatment, taking into account the patient’s personal wishes and unique characteristics such as age, availability of at-home care, history of side effects and more. Most MBC treatments are generally provided in a range of dosages. When starting a treatment, patients are usually placed on the standard (highest) dose – which can cause the most side effects.
Just months after the PCDI delivered an oral presentation at ASCO 2021 about the results of its MBC Patient Survey in which 86% of 1,221 respondents indicated they had experienced at least one bad treatment-related side effect, the FDA declared, “It’s loud and clear from our patients that the drugs are too toxic… patients deserve a more tolerable dose.”
And the FDA is putting actions to these words. The FDA launched “Project Optimus” to halt the decades-old practice of identifying and leveraging the MTD, and is issuing guidance to pharmaceutical companies to identify two or more doses based on efficacy and tolerability. So the longstanding practice of leveraging the most toxic “tolerable” dose is being terminated.
Furthermore, the FDA has begun scrutinizing existing oncology drugs that were based upon the MTD. To this end, the FDA’s “Project Renewal” initiative is working to ensure that labeling information for older oncology drugs is clinically meaningful and up to date. As a direct result of Project Renewal’s efforts, the labeled starting dose of the oral chemotherapy drug capecitabine (Xeloda) has been adjusted to render it more tolerable.
Join us for a webinar targeted specifically to our Pharma/Biotech members to learn more about the initiative from PCDI patient advocate Julia Maués — how it came about, the incredible work that the team has already done, and how it has now become a project of the Alliance. Please feel free to forward this to any of your colleagues who might be interested in attending.
After registering, you will receive an immediate, on-screen confirmation containing the unique link you'll need to join. Just click on "Add to calendar" on that screen —
| 
