Optimizing the FDA's Project Optimus: Opportunities and Challenges

Overview

Journal Nat Rev Clin Oncol

Specialty Oncology

Date 2023 Dec 21

PMID 38129533

Authors

Simon Rodney

Udai Banerji

Affiliations

Soon will be listed here.

Citing Articles

Opportunities for Precision Dosing of Cytotoxic Drugs in Non-Small Cell Lung Cancer: Bridging the Gap in Precision Medicine.

Kicken M, Deenen M, van der Wekken A, van den Borne B, van den Heuvel M, Ter Heine R Clin Pharmacokinet. 2025; .

PMID: 40045151 DOI: 10.1007/s40262-025-01492-6.

Collaborative Innovations in Childhood Cancer Therapies.

Valtingojer I, Lievre S, Bordes P, Paranjpe K, Thompson W, Shah S Handb Exp Pharmacol. 2024; 286:33-50.

PMID: 39177748 DOI: 10.1007/164_2024_725.

A mechanistic PK/PD model of AZD0171 (anti-LIF) to support Phase II dose selection.

Shahraz A, Penney M, Candido J, Opoku-Ansah G, Neubauer M, Eyles J CPT Pharmacometrics Syst Pharmacol. 2024; 13(10):1670-1681.

PMID: 39041713 PMC: 11494920. DOI: 10.1002/psp4.13204.

Cytotoxicity and Multi-Enzyme Inhibition of Stem Extract on H838 Human Non-Small Cell Lung Cancer Cells and RPA32, Elastase, Tyrosinase, and Hyaluronidase Proteins.

Lee C, Chen Y, Huang Y, Lien Y, Huang C Plants (Basel). 2024; 13(6).

PMID: 38592804 PMC: 10974603. DOI: 10.3390/plants13060797.

References

Roda D, Jimenez B, Banerji U . Are Doses and Schedules of Small-Molecule Targeted Anticancer Drugs Recommended by Phase I Studies Realistic?. Clin Cancer Res. 2015; 22(9):2127-32. DOI: 10.1158/1078-0432.CCR-15-1855. View

Hong D, Fakih M, Strickler J, Desai J, Durm G, Shapiro G . KRAS Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020; 383(13):1207-1217. PMC: 7571518. DOI: 10.1056/NEJMoa1917239. View

Hennessy B, Gauthier A, Michaud L, Hortobagyi G, Valero V . Lower dose capecitabine has a more favorable therapeutic index in metastatic breast cancer: retrospective analysis of patients treated at M. D. Anderson Cancer Center and a review of capecitabine toxicity in the literature. Ann Oncol. 2005; 16(8):1289-96. DOI: 10.1093/annonc/mdi253. View

Brose M, Panaseykin Y, Konda B, De La Fouchardiere C, Hughes B, Gianoukakis A . A Randomized Study of Lenvatinib 18 mg vs 24 mg in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer. J Clin Endocrinol Metab. 2021; 107(3):776-787. PMC: 8852210. DOI: 10.1210/clinem/dgab731. View

Yap T, Kristeleit R, Michalarea V, Pettitt S, Lim J, Carreira S . Phase I Trial of the PARP Inhibitor Olaparib and AKT Inhibitor Capivasertib in Patients with - and Non--Mutant Cancers. Cancer Discov. 2020; 10(10):1528-1543. PMC: 7611385. DOI: 10.1158/2159-8290.CD-20-0163. View