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With Iclusig’s Return, Ariad Gets A Second Chance To Get The Dose Right

 
• By Sue Sutter

In allowing ponatinib back on the market, FDA is requiring the sponsor to address a gap in the original development program – failure to identify the optimal dose. However, Ariad is also looking at the post-marketing requirements as a step in the pathway to use in earlier treatment settings.

Post-marketing requirements attached to FDA’s recent decision allowing Ariad Pharmaceuticals Inc.’s Iclusig (ponatinib) back on the market offer a second chance to clarify dosing of the leukemia drug, which has been linked to increasing rates of serious cardiovascular events since its December 2012 accelerated approval.

The requirement for a clinical trial comparing the safety of different ponatinib doses is aimed at addressing what FDA has...

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More from United States

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

 
• By Bridget Silverman

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

Pink Sheet Podcast: CBER Director’s Political Spin On COVID-19 Vaccines And US FDA RIFs Finalized

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

More from North America

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 
• By Alaric DeArment and Cathy Kelly

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

Part B Negotiation Proposal Would Lower Prices In MA, Private Plans Too, Stakeholders Complain

 
• By Cathy Kelly

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.

‘Missed Opportunity’: GSK Failed To Optimize Blenrep Dosage, US FDA Panel Says

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee said the benefit-risk of belantamab mafoditin for two second-line multiple myeloma indications is not favorable at the proposed dosages and raised concerns about applicability of trial results to US patients.