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Alimta Lung Cancer Label Expanded To Include Longer Use

 
• By Emily Hayes

FDA has set a high bar for maintenance indications, which allow longer term use. With overall survival data, Eli Lilly’s Alimta (pemetrexed) has met that hurdle and is now approved for longer use in first-line nonsquamous non-small cell lung cancer.

Eli Lilly & Co.’s Alimta (pemetrexed) now has a new indication allowing longer-term use in first-line treatment of nonsquamous non-small cell lung cancer under its blockbuster belt.

Maintenance therapy – treatment given for longer periods of time to prevent disease progression – has obvious benefits for the...

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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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Publisher’s Spotlight: Shortlist Unveiled For Citeline Japan Awards

 
• By Ian Haydock

Shortlists of potential winners in all categories of the Citeline Japan Awards 2025 have now been released. Join us at the event in Tokyo on October 21, it’s not too late to book your table!

Ex-CDC Leaders Reveal New Details Of Kennedy’s Plans For ACIP, Vaccine Schedule

 
• By Sarah Karlin-Smith

The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.

More NME Reviews, Reduced Costs Combine To Lower US FDA Voucher Fee

 
• By Derrick Gingery

The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.