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Premarket Dose Optimization Precedent In Oncology Likely Not Available Yet

 
• By Derrick Gingery

The current crop of cancer drug approvals were well along in development when Project Optimus launched, meaning they may not have been able to implement the Oncology Center of Excellence’s premarket dose optimization policy.

Mirat Shah at the Friends of Cancer Research Annual Meeting
The FDA's Mirat Shah discusses Project Optimus during the Friends of Cancer Research Annual Meeting. • Source: Screenshot of internet broadcast

The current class of oncology drug approvals may not be the best example of the US Food and Drug Administration’s evolving approach to dose optimization policy.

Agency officials began pushing oncology sponsors more than a year ago to change from looking for the maximum tolerated dose to finding the optimal dose prior to approval.

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More from Approval Standards

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

More from Pathways & Standards

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EMA Rejects Treatments For Pediatric Myopia & CTCL

 
• By Vibha Sharma

EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.