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Complete Response Letter For Outlook’s Bevacizumab Is Both Straightforward And Elusive

Low On Cash, Rush Is On To Clarify US FDA’s Concerns

 
• By Mandy Jackson

Paralleling the challenges of the wet AMD market it hopes to enter, the CRL for Lytenava cites manufacturing issues, which Outlook Therapeutics feels it can easily address, as well as the need for confirmatory clinical evidence, which has left the firm scrambling for a meeting with FDA.

Close up cropped shot, face of senior woman eye looking straight, into distance.
Outlook will request at Type A meeting with the FDA to discuss the CRL • Source: Shutterstock

The complete response letter for Lytenava that Outlook Therapeutics, Inc. revealed on 30 August parallels in many ways the challenges of the wet age-related macular degeneration market that firm is trying to enter with its proprietary formulation of bevacizumab: It is both straightforward and elusive.

About 50% of the wet AMD patients in the US are treated with compounded versions of I.V. bevacizumab, which leads to safety and efficacy issues due to contamination and inconsistencies, according to Outlook

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More from Complete Response Letters

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

US FDA Miss On Stealth’s Elamipretide Boosts Signal Of Broader Delays Due To Staff Cuts

 
• By Sue Sutter

Failing to meet the 29 April user fee date for the Barth syndrome treatment, and CDER’s request for a delay in responding to Vanda’s appeal of a tradipitant complete response letter, suggest a slowdown in review work due to layoffs and other recent changes.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 
• By Dexter Jie Yan

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

More from Product Reviews

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.