With First US Approval, BeiGene’s Tevimbra To Start Small, Work Its Way Up

The FDA approved the PD-1 inhibitor for previously treated esophageal cancer, while BeiGene anticipates decisions on first-line ESCC as well as G/GEJ cancer later in the year.

• Source: Shutterstock

BeiGene, Ltd.’s initial US Food and Drug Administration approval of Tevimbra (tislelizumab) for a relatively small esophageal cancer indication offers a foot in the regulatory and commercial door before the company brings it into a much wider array of cancers affecting the esophagus, which could happen before the end of the year.

The drug maker announced FDA approval on 15 March for Tevimbra to treat esophageal squamous cell carcinoma (ESCC) as a...

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

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By 

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

Atai/Beckley Merger Comes At A Transformative Time For Psychedelics

 
• By 

All eyes are on the upcoming readout of BPL-003 for treatment-resistant depression.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
• By 

The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.

Sanofi Plays It Safer With Blueprint Buy After Bumpy 2025

 
• By 

But the French major is still keen on early-stage M&A.

More from Scrip

Deal Build-Up Amid Early ‘Deep’ Response For IGI’s Trispecific In Myeloma

 

IGI CEO tells Scrip about the “very encouraging” feedback at ASCO to promising early data for the firm's first-in-class investigational trispecific antibody in multiple myeloma. Is a licensing deal in the offing?

Ascletis Plans China Submission After Positive Denifanstat Phase III Acne Results

 

Once-daily oral FASN inhibitor denifanstat meets all endpoints in a Chinese Phase III trial for moderate-to-severe acne, paving the way for a regulatory submission in China.

Finance Watch: Vera Raises Debt, Taysha And Trevi Price Offering After Big Trial Wins

 
• By 

Public Company Edition: Public company funding in 2025 is down from 2024, but after recent positive data readouts Vera accessed up to $450m in new debt, while Taysha and Trevi grossed $200m and $100m, respectively, in stock offerings. Meanwhile, Keros, Stealth and others cut jobs.