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Keeping Track: Opdivo, Keytruda Continue Adjuvant Push As Cancer Dominates Recent Applications

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The expansion of oncology drug classes into earlier stages of cancer has been on display in the US FDA approval queue, from adjuvant indication submissions for Bristol Myers Squibb Company’s Opdivo in completely resected stage IIB or IIIC melanoma and Merck & Co., Inc.’s Keytruda in resectable stage II, IIIA or IIIB non-small cell lung cancer to the US FDA approval of an expanded early breast cancer indication for Eli Lilly and Company’s Verzenio.

The agency also received oncology applications for Pfizer Inc.’s elranatamab, Checkpoint Therapeutics, Inc.’s cosibelimab, Aldeyra Therapeutics, Inc.’s...

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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.