Subcutaneous on-body device delivery of anti-CD38 antibodies like isatuximab nearly eliminates the high risk of infusion-related reactions common with intravenous administration, especially during the first dose. This significantly enhances patient safety and comfort in the clinic.
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Non-human primate models are poor predictors of human immunogenicity. The industry has shifted to human-relevant ex vivo assays using whole blood or PBMCs. These tests can assess risks like complement activation upfront, enabling proactive protein engineering to improve a drug's safety profile.
The on-body injector's fixed, flat-rate dosage simplifies clinical workflow and improves safety by eliminating the need for constant, error-prone dose recalculations based on patient weight changes, which is standard for many body surface area (BSA)-based cancer therapies.
Administering complex biologics at home via on-body devices can bridge significant healthcare disparities. This model can eliminate the physical, financial, and geographic barriers faced by patients in rural areas or those reliant on caregivers for transport to infusion centers.
The rapid and successful rollout of complex bispecific therapies into community settings is primarily driven by enhanced nursing staff skills and protocols for risk stratification. This combination allows for safe outpatient administration, preventing hospital admissions and broadening patient access beyond large academic centers.
A key trend in 2025's drug approvals is that "best-in-class" therapies are distinguished not just by efficacy, but by innovations in formulation and delivery that improve the patient experience. Examples include subcutaneous versions of IV drugs and new delivery methods that expand patient access.
While personalized cancer vaccines require extracting and processing a patient's tumor, Create Medicines' in vivo approach is entirely off-the-shelf. By delivering the programming directly into the body, they enable the patient's own immune system to do the complex, personalized work of attacking the cancer itself.
Early data from an in vivo CAR-T therapy suggests a paradigm shift is possible. By engineering T-cells directly inside the patient with a simple infusion, this approach could eliminate the need for leukapheresis and external manufacturing, completely disrupting the current cell therapy model.
When efficacy and safety profiles are comparable between ADCs like sacituzumab and datopotamab, the final choice can be guided by patient logistics. Factors include infusion frequency (Day 1 & 8 vs. every 3 weeks) and total time spent at the infusion center.
Recent FDA approvals for Milestone's Cardamist nasal spray and J&J's subcutaneous Ribrevent Fastpro highlight a key industry trend: improving patient convenience. These products shift treatment from clinical settings to on-demand, at-home use or reduce administration time, creating value beyond just clinical efficacy.
Clinical trial data shows that despite specific toxicities, antibody-drug conjugates (ADCs) can be better tolerated overall than standard chemotherapy. For example, trials for both sacituzumab govitecan and dato-DXd reported fewer patients discontinuing treatment in the ADC arm compared to the chemotherapy arm.