CAR-T Companies Hang Onto Novartis' Coat-Tails After Historic FDA Panel Vote

The FDA panel landmark recommendation for Novartis' CTL019 should provide a fillip for the other players in the CAR-T field but the response from the investment community has been lukewarm compared with researchers and patients.

Human tower
Standing strong: FDA panel nod may boost other CAR-T players • Source: Shutterstock

The momentous news that the FDA's Oncologic Drugs Advisory Committee has recommended approval of Novartis AG’s CTL019 has provided a boost not only for the Swiss major but for the rest of the players in the chimeric antigen receptor T cell (CAR-T) market.

The ODAC voted 10-0 in favor of CTL019 (tisagenlecleucel) for pediatric leukemia, a decision that as good as guarantees that the therapy, developed by extracting cells, reengineering them to target CD19 to fight cancer and

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 Immuno-oncology

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

Merck Set To Add Perioperative Head-And-Neck Cancer To Keytruda Label

 
• By 

With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.

Akeso Explains Ivonescimab Prelim OS Data After Investors’ Negative Reactions

 

Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.

Gilead Pipeline Progress Offsets Oncology Sales Slowdown

 

Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.

More from Anticancer

BioNTech Aims To Diversify BNT323 Manufacturing As Filing Nears

 

The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.

In Brief: Genmab To Seek FDA Nod For Epkinly In Lymphoma

 

Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.

Merck & Co. CMO Barr On Breaking Into Immunology And Ophthalmology

 

Chief medical officer Eliav Barr discussed Merck’s investment in new therapeutic areas and business development in an interview with Scrip.