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Oncopeptides’ Melflufen: Same Data, Different Conclusions From EMA, US FDA

 
• By Francesca Bruce

The two regulators were an OCEAN apart on their interpretation of the overall survival and progression-fee survival data from the Phase III confirmatory trial. European regulators saw fit to recommend Pepaxti’s approval, even after the drug was voluntarily discontinued in the US market due to FDA concerns.

Atlantic Ocean
EU and US regulators were an OCEAN apart in their conclusions on melflufen's efficacy. • Source: Shutterstock

The future of Oncopeptides AB’s multiple myeloma treatment Pepaxto (melphalan flufenamide) in the US remains hazy given the company’s decision in 2021 to discontinue marketing the drug, although it has not yet formally agreed to the Food and Drug Administration’s request to withdraw the new drug application.

However, the same drug, branded as Pepaxti, lives on in the EU, where regulators overcame several concerns that the FDA...

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More from Approvals

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

More from Product Reviews

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 
• By Eliza Slawther

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.