BIG Change Regarding Dosing as per the FDA!

Bestbird

Great news! The decades-long paradigm of leveraging the highest and most toxic dose of a cancer drug, called the Maximum Tolerated Dose (MTD), may be coming to an end.

Shortly after the Patient-Centered Dosing Initiative's presentation about MBC patients' treatment-related side effects at ASCO's 2021 worldwide conference, Richard Pazdur, Director of the FDA's Oncology Center of Excellence, stated that the FDA will start requiring drug companies to test the efficacy of multiple drug doses during clinical trials instead of identifying and moving forward with the MTD.

This is a game-changer because the MTD, which is identified in Phase 1 clinical trials that focus solely on toxicity, is the dose that generally causes the most severe side effects. In today's world, whenever patients with MBC begin a new treatment, they are generally prescribed the MTD unless there's a medical contraindication. But in tomorrow's world, at least two doses will be identified in Phase 1 clinical trials for further study so that ultimately the optimal dose - based upon a balance of efficacy and toxicity - will be given to patients.

Please join a webinar hosted by Friends of Cancer Research on Wednesday, Nov. 10th at 12PM ET. Panelists including the FDA, pharmaceutical companies, Friends of Cancer Research, and myself, will be discussing the transformation of MTD-based oncology studies. If interested, register here: https://friendsofcancerresearch.org/events/friends...

Moissy

This is wonderful news! Thank you, Anne, for your efforts!

Tina2

This is HUGE!

Speaking as someone who nearly bought the farm on the highest dose of Ibrance, I appreciate this development more than I can say.

Great work, Anne. Thank you!

Tina

cowgal

Thanks Bestbird for posting this! I certainly think that since some of us are are these long term, it would be great to have an optimal dose that may be less than the MTD and maybe help us lessen some of the side effects and improve QOL!

Bestbird

I'm glad you're encouraged as much as I am!

Even with this new, fantastic direction, the Patient-Centered Dosing's mission of encouraging dosage-related discussions between oncologists and patients will still be needed because:

1) Patients' responses in the real-world differ from those of participants in clinical trials because the former are not subject to rigid inclusion and exclusion criteria

2) It will take a while for new drugs being developed to leverage the new paradigm, and drugs currently on the market will still be prescribed based upon the MTD

3) Patients will always have unique personal attributes (co-morbidities, drug sensitivities, etc.)

That said, identifiying and leveraging the optimal dose in lieu of the MTD is an enormous step forward that will substantially improve quality of life!

LGP1111

Wow! This is a timely update for me. I just started Ibrance at the highest dose (125 mg) and my counts TANKED. ANC = 0.30 and WBC = 0.91. Obviously intolerable, and who knows if I can even tolerate the next lowest dose. We will see. But optimal dosing is critical.

Thanks,

Lisa