Fluorouracil

3D printing revolutionized manufacturing, including pharmaceuticals, enabling rapid production of complex objects and personalized medicine. SPRITAM, the first 3D printed oral suspension tablet, was approved in 2015. The technique offers flexibility in dosage forms and drug release profiles. Clinical trials for 3D-printed treatments are limited but promising, with potential market growth. Excipients like HPMC play a crucial role in 3D printing, supporting various release profiles. Challenges include regulatory requirements, quality control, cost, and excipient selection.

FY 2025 appropriations negotiations are on hold due to the general election; NIH funding remains a focus for the medical research community. The FDA's Oncologic Drugs Advisory Committee discussed PD-L1 expression as a biomarker for anti-PD-1 therapies, potentially leading to changes in drug labeling. An FDA-AACR workshop on DPD deficiency testing before chemotherapy with fluoropyrimidines is scheduled for January 16, 2025. Representatives Wasserman Schultz and DeGette urged the FDA to finalize e-cigarette PMTA reviews. The FDA approved five oncology drugs and new indications between September 21 and October 25, 2024.

The October issue of Dermatology Times covers intralesional 5-fluorouracil for SCC in older patients, new AD treatment targets, evolving aesthetics, and distinguishing medical vs. cosmetic hyperpigmentation.

Cindy Medina Pabon discusses the FDA approval of zolbetuximab-clzb (Vyloy) for HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. Zolbetuximab, combined with chemotherapy, was approved based on SPOTLIGHT and GLOW trials, showing survival benefits. This marks a significant advancement in targeted therapy for gastric cancer.

Merrimack Pharmaceuticals, a biotech company focused on cancer treatment, has five oncology candidates in clinical development. Its most advanced candidate, MM-398, is in a global phase III study for pancreatic cancer. Merrimack also has candidates like MM-121, developed with Sanofi, in various cancer trials. Despite significant operating losses, the company's IPO raised $100.5 million, funding operations into the second half of 2013.

FDA approves 420-mg trastuzumab-strf for HER2-overexpressing cancers, and zolbetuximab for CLDN18.2-positive gastric/GEJ adenocarcinoma. FDA delays decision on sotorasib plus panitumumab for KRAS G12C-mutated CRC to Jan 2025. LP-184 granted fast track designation for glioblastoma treatment.

Study compares 5-Fu-DEB-TACE and 5-Fu-cTACE for unresectable HCC, finding 5-Fu-DEB-TACE more effective with better tumor response, longer PFS, less liver function damage, but higher pain incidence. BCLC stage, MELD score, and ascites are independent predictors for PFS. 5-Fu-DEB-TACE using CSMs shows superior short-term efficacy and PFS. Liver function and tumor burden significantly impact prognosis, with 5-Fu-DEB-TACE more effective in lower tumor burden and better liver function cases. No treatment-related deaths, with comparable safety profiles between methods. Study limitations include insufficient follow-up, single-center sample, and challenges in tumor response assessment.

Revolution Medicines, Inc. announced the first patient dosed in RASolute 302, a Phase 3 study of RMC-6236, a RAS(ON) inhibitor for metastatic pancreatic ductal adenocarcinoma (PDAC). The study aims to evaluate RMC-6236's safety and efficacy compared to standard chemotherapy, enrolling 460 patients worldwide with RAS mutations. Primary endpoints are progression-free survival (PFS) and overall survival (OS) in RAS-mutated PDAC patients.

Revolution Medicines, Inc. announced the first patient dosed in RASolute 302, a Phase 3 study of RMC-6236, a RAS(ON) inhibitor for metastatic pancreatic ductal adenocarcinoma (PDAC). The trial aims to evaluate RMC-6236's safety and efficacy compared to standard chemotherapy, enrolling 460 patients globally. Primary endpoints are progression-free survival (PFS) and overall survival (OS) in patients with RAS mutations.