AstraZeneca Tries Plan B For Dato-DXd After Regulator Feedback

The FDA has indicated that the antibody-drug conjugate looks more promising in a subgroup of EGFR mutated lung cancer patients and AstraZeneca has refiled accordingly.

AstraZeneca and partner Daiichi Sankyo have unveiled a major change of plan for the first filing of their closely-watched lung cancer therapy datopotamab deruxtecan (Dato- DXd).

The companies filed Dato-DXd with the US Food and Drug Administration for patients with advanced or metastatic nonsquamous non-small cell...

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 Scrip

Regulatory Setbacks Dim Otherwise Strong Quarter For Regeneron

 

Eylea HD saw significant sales growth, but the company reported delays in FDA approvals for the drug and a CRL for its CD20xCD3-targeting bispecific for lymphomas.

Metabolic Disease-Focused Poxel Teeters On The Edge

 

The Lyon, France-based company has filed for insolvency and is running out of time to find new funding for its metabolic disease pipeline.

UCB Takes A Bow as Bimzelx HS Launch Achieves Lift-Off

 
• By 

The Belgian company has raised its outlook for full-year sales following a strong launch for Bimzelx in hidradenitis suppurativa in the first half of 2025.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

 

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

More from R&D

Blenrep Questions Won’t Go Away But GSK Sees Chance To Lead In COPD

 

GSK is sticking to its guns on its forecasts for Blenrep and the firm’s total sales in 2031 despite concerns about the antibody-drug conjugate’s approvability in the US.

PTC To Challenge BioMarin In PKU With Oral Sephience

 
• By 

PTC plans to compete with BioMarin’s two phenylketonuria drugs with efficacy data showing strong reduction of phenylalanine and ability for patients to liberalize their diets.

Lilly’s Jaypirca Threatens Imbruvica’s CLL Position After Phase III Results

 

The BRUIN CLL-314 trial was designed to show noninferiority, but the p-value indicated a favorable result for Jaypirca in both the pre-treated and intent-to-treat populations.