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Teva’s Synribo Clears FDA For Third-Line Chronic Myeloid Leukemia

 
• By Sue Sutter

Omacetaxine, which was originally submitted by ChemGenex as Omapro, demonstrated response rates of 14% to 18% in patients who had failed two or more tyrosine kinase inhibitors. It enters a crowded space that is likely to add a new member, Ariad’s ponatinib, in the coming months.

FDA approval of Teva Pharmaceutical Industries Ltd.’s Synribo (omacetaxine mepesuccinate) is a validation of the chronic myeloid leukemia drug’s efficacy in a salvage setting, but its commercial prospects may be limited by a narrow population, modest efficacy and an increasingly crowded therapeutic space that is expected to grow even more so in the coming months.

The agency granted accelerated approval to Synribo, a protein synthesis inhibitor that is administered subcutaneously, on Oct. 26 for treatment...

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More from United States

Cancer Drug Combos: US FDA Guidance Offers Options Beyond Factorial Trials

 
• By Manas Mishra

Acknowledging the risks and limitations of factorial designs, draft guidance outlines how sponsors might employ external data, such as registries or patient-level real-world data, for combination cancer therapies.

US FDA Rare Disease Hub RISEs After Slow Start

 
• By Michael McCaughan

The first “Rare disease Innovation, Science and Exploration (RISE) meeting to discuss the choice of control arms for studies in small populations will be Sept. 3 after plans were delayed by ongoing changes at the FDA.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

More from North America

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions

 
• By Sarah Karlin-Smith

Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

Inside Elamipretide’s CRL: Clinical And Surrogate Evidence Deficiencies, And A Path Forward

 
• By Sue Sutter

The Pink Sheet takes an exclusive look at the complete response letter, which shows the information on application deficiencies that could become widely available if FDA leaders succeed in releasing CRLs in real time.