Spectrum Sees Potential Path For Poziotinib In NSCLC Despite Expected CRL

The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.

The FDA sent a complete response letter to Spectrum for poziotinib in NSCLC • Source: Shutterstock

The US Food and Drug Administration handing a complete response letter (CRL) to Spectrum Pharmaceuticals Inc. for poziotinib in previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations came as little surprise. But despite the company deprioritizing the program and laying off most of its R&D workforce, it still sees poziotinib as having a potential future, perhaps by partnering or selling it to a company that could take it forward.

Spectrum announced its receipt of the CRL on 25 November, adding that based on the letter, the company would have to generate additional data, including a randomized, controlled trial, to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from New Products

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.

Pipeline Watch: Eight Approvals And Nineteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Delay Sends Biohaven Shares Down

 

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

More from Scrip

Merus Bispecific Impresses In Head And Neck Cancer

 

Updated Phase II results from petosemtamab have impressed ahead of ASCO, outshining Keytruda monotherapy and its bispecific rival from Bicara.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
• By 

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

Challenging Environment For Biopharma Is A Tailwind For Royalty Pharma

 

The royalty revenue stream acquirer has around 40 products in its portfolio and expects to generate roughly $3bn this year. Head of R&D and investments Marshall Urist talked about the investment strategy at the RBC Healthcare Conference.