1. Scrip
  2. >>New Products

Aadi Starts Small With Fyarro, But Has Tumor-Agnostic Strategy In Mind

 
• By Alaric DeArment

The approval of Fyarro marks the first for advanced malignant PEComa, a rare cancer that affects only 100-300 people in the US; it's also the first launch for Aadi Biosciences.

Digital illustration of Cancer cell in colour background
Aadi won FDA approval for Fyarro in PEComa, a rare form of sarcoma • Source: Shutterstock

AADi Bioscience, Inc.’s Fyarro (nab-sirolimus) is the first drug approved by the US Food and Drug Administration for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), a rare and aggressive sarcoma with limited treatment options. The market for PEComa is very niche, but Aadi expects to expand the commercial market for Fyarro over time through a tumor-agnostic strategy targeting patients with cancers harboring TSC1 and TSC2 mutations

The approval, which marks the first for Aadi, came on 23 November, days ahead of the 26 November action date

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
Start Free Trial

Already a subscriber?

More from New Products

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

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.

Merck KGaA Seals SpringWorks Buy

 
• By Kevin Grogan

The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
• By Dexter Jie Yan

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

More from Scrip

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

 
• By Sushmita Panda

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

Pharma Predicts Modest Impact From Tariffs, But It Depends On What Comes Next

 
• By Jessica Merrill

Drugmakers aren’t expecting a big financial hit from tariffs for now, but a report commissioned by PhRMA suggests the cost of pharma-sector tariffs could be steep.

OPPI’s Matai On Section 3(d) Of India’s Patent Regulations: Now’s The Time To Open Up

 
• By Anju Ghangurde

Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.