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Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons

 
• By Sarah Karlin-Smith

Merck’s path forward is less clear than Genentech’s after US FDA’s Oncologic Drugs Advisory Committee says Keytruda and Tecentriq should hold on to their accelerated approvals for locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy. FDA has to figure out a confirmatory study for Merck and weigh potentially limiting indication. 

two different, diverging roads
Keytruda and Tecentriq took different paths to positive ODAC votes • Source: Alamy

Two different US Food and Drug Administration panels voted in favor of keeping Merck & Co., Inc. and Genentech, Inc. ’s accelerated approvals for their respective PD-1/L1 inhibitors in bladder cancer, but the reasoning for the two 28 April votes was quite different despite the similarity of the immunotherapies and the indications.

For Merck’s Keytruda (pembrolizumab) the Oncologic Drugs Advisory Committee members were persuaded by the unmet need of a fraction of...

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More from US FDA Performance Tracker

October US FDA User Fee Goals: Few Novel Agents, But Many New Indications As Shutdown Looms

 
• By Bridget Silverman

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

J&J’s Inlexzo Is A Rare 505(b)(2) NDA To Qualify For US FDA’s Real-Time Oncology Review

 
• By Bridget Silverman

A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

More from Regulatory Trackers

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency

 
• By Bridget Silverman

The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.

Rare Disease Tests Aplenty On US FDA’s September User Fee Calendar

 
• By Bridget Silverman

US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.

US FDA Emphasizes Primary Endpoint Primacy In Vatiquinone, Lytenava CRLs

 
• By Bridget Silverman

The complete response letters call for a new trial for PTC’s vatiquinone and more confirmatory evidence for Outlook Therapeutics’ Lytenava, while Telix’s Zircaix CRL shows quality challenges for a novel radiopharmaceutical approach.