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Inlyta Approval Expands Pfizer Kidney Cancer Options, But With Unique Safety Profile

 
• By Shirley Haley

Second-generation VEGF inhibitor Inlyta (axitinib) gained approval based as much on its complementary safety profile as its superiority in a head-to-head comparison with Bayer/Onyx’s Nexavar .

FDA’s approval of Pfizer Inc.’s oral second generation VEGF inhibitor Inlyta (axitinib) for advanced kidney cancer appears to have been motivated not as much by its superiority in a head-to-head comparison with Bayer HealthCare LLC/Onyx Pharmaceuticals Inc.’s Nexavar as its safety profile, which was broadly similar to Nexavar’s but oddly complementary in that the toxicities associated with the two drugs were quite different, making it an attractive addition to the armamentarium.

Inlyta’s Jan. 27 clearance for treatment of patients with advanced kidney cancer who have not responded to earlier therapies makes...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.