Merck, Daiichi End Plans to Seek Speedy Approval of Lung Cancer ADC

Pharmalittle: We're reading about GLP-1s becoming lifestyle drugs, a setback for Merck and Daiichi, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is honeybush vanilla turmeric. For the full experience, we are now hawking replicas — take a look. Meanwhile,…

MSD, Daiichi pull filing for lung cancer candidate I-DXd

MSD and Daiichi Sankyo's regulatory efforts for their ADCs for cancer have stuttered again, with a withdrawn filing for lung cancer candidate I-DXd.

Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.  

Merck, Daiichi pull lung cancer filing after FDA pushback deals another blow to $4B deal

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Merck, Daiichi scrap FDA application for B7-H3 ADC in lung cancer

In yet another setback to the Merck and Daiichi Sankyo partnership, the companies said they have pulled their FDA accelerated approval application for an antibody-drug conjugate (ADC) in certain small cell lung cancer (SCLC) patients. ...

Daiichi Sankyo, MSD withdraw cancer drug application

Daiichi Sankyo and Merck & Co (MSD) have voluntarily withdrawn their biologics license application (BLA) for ifinatamab deruxtecan, aimed at treating adult patients with extensive-stage small cell lung cancer (ES-SCLC).