Janice Cowden: We Must Keep Pushing Until Tolerability, Quality of Life, and Individualized Dosing

Janice Cowden, Cancer patient and MBC Cancer Advocate, shared a post by Friends of Cancer Research on LinkedIn:

“Reposting this important update from FDA and American Society of Clinical Oncology (ASCO) on cancer drug dosing principles — but even more so, I want to shine a light on Anne Loeser (top right of the video screenshot).

Anne, who passed away from MBC in October 2023, was a brilliant and fierce patient advocate living with metastatic breast cancer, an author (Insider’s Guide to Metastatic Breast Cancer), and the founder of the Patient-Centered Dosing Initiative (PCDI). She was ahead of her time in pushing for optimized, patient-focused dosing for Oncology drugs.

In 2019, she founded PCDI because she knew what too many of us living with MBC already felt firsthand — dosing is not one-size-fits-all. Her groundbreaking 2020 survey of 1,200+ patients showed clearly that oncology drugs are too toxic at standard trial doses (MTD).

After Anne’s powerful presentation at American Society of Clinical Oncology (ASCO) annual meeting in 2021, her mission and vision for dose optimization moved beyond the patient community and began shaping conversations across the oncology field. What had started as a patient-driven call for change quickly gained traction with regulators, researchers, and industry leaders. Later that year, Anne was invited to join FDA leaders as a patient advocate panelist at the Friends of Cancer Research Annual Meeting, helping ensure that the patient voice remained central to this pivotal discussion.

And yet, despite this progress, clinical trials still default to the archaic maximum tolerated dose (MTD) model. Patients don’t just want to live longer — we want to live better.

Anne’s brilliance, courage, and relentless patient-centered focus laid the foundation for this shift. Today’s FDA/ASCO guidance is a step forward, but the work Anne started reminds us we must keep pushing until tolerability, quality of life, and individualized dosing are central to every trial.

Seeing this post from Friends of Cancer Research brings hope that we’re making progress, yet bittersweet seeing Anne in this video, remembering and missing my dear friend whose legacy we continue to honor by advocating for Dose Optimization through the patient-founded, patient-led organization she created 6 years ago (the Patient-Centered Dosing Initiative – PCDI).”

Quoting Friends of Cancer Research’s post:

“The FDA and American Society of Clinical Oncology (ASCO) recently published five principles on tolerability and dosing of oncologic therapies for drug sponsors, advocating for a paradigm shift away from the traditional maximum tolerated dose (MTD) approach. These principles encourage the use of modern clinical trial designs, comprehensive patient safety and tolerability data, and broader eligibility criteria in dose optimization trials to increase the generalizability of results to real-world patients.

Over the years, the FDA Oncology Center of Excellence (OCE) has refined its recommendations for drug toxicity and dosing, including launching Project Optimus, a collaborative initiative with industry, academia, and patients to reform the dose optimization and dose selection paradigm in oncology drug development, which Friends of Cancer Research’s work supports.

Our ongoing dosing and tolerability portfolio spans over a decade of work. We have convened stakeholders in government, academia, advocacy, and industry to explore optimal dosing strategies, incorporate patient-reported outcomes in early-phase trials, and advance tools that help identify doses that balance efficacy and tolerability.

Our 2021 Annual Meeting panel on ‘Maximizing Benefit and Improving Tolerability’ highlighted dose optimization efforts in action. Hear Dr. Mirat Shah, Medical Oncologist and Clinical Reviewer at the FDA, emphasize the importance of drug makers considering dose optimization early as a key component for ensuring drug safety and effectiveness and discussing these strategies with the FDA at milestone meetings.

Optimizing dosing to support patient tolerability is critical for extending survival outcomes while also improving quality of life. Through more structured regulatory guidance, we can ensure these principles translate into more efficacious, better-tolerated therapeutic interventions. Read the full story from Regulatory Focus, a Regulatory Affairs Professionals Society (RAPS) publication.”

Read more.

Proceed to the video attached to the post.

More posts featuring Janice Cowden on OncoDaily.