1. Scrip
  2. >>New Products

Lead Daiichi/Merck ADC Collab HER3-DXd Hit With CRL

Manufacturing Findings

 
• By Ian Haydock and Lisa Takagi

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.

The CRL is related to the inspection of a third-party manufacturer, Daiichi Sankyo and Merck noted.
patritumab CRL related to inspection of third-party manufacturer • Source: Shutterstock

Daiichi Sankyo Co., Ltd./Merck & Co., Inc.’s first collaborative antibody-drug conjugate (ADC) asset, patritumab deruxtecan (HER3-DXd), has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA), the two firms disclosed on 26 June, the original action date under the Prescription Drug User Fee Act (PDUFA).

The CRL for the potentially first-in-class HER3-targeting therapy was related solely to (unspecified) findings in an inspection of a third-party...

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

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

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 Kevin Grogan

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 Andy Smith

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 Kevin Grogan

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

More from Scrip

Executives On The Move: Three New CEOs And CFOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Mitsubishi Tanabe Pharma and MC2 Therapeutics, plus MindMed acquires chief financial officer from Longboard Pharma.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 
• By Sushmita Panda

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

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

 
• By Anju Ghangurde

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?