Daiichi Sankyo Company, Limited

In Europe, there's a decision in breast cancer.

The EU has approved AstraZeneca and Daiichi Sankyo's Enher2, a HER2-directed antibody drug conjugate, for use after surgery.

It covers adults whose HER2-positive early breast cancer showed residual invasive disease at surgery after pre-surgery treatment with a taxane and HER2-targeted therapy.

The approval rests on Phase III results reported previously.

Sondra Butterworth, I mean, with diversity and inclusion, she is literally the queen.

And then industry wise, I do think Guna from Daiichi is leading the way with best practices for pharma.

It's pep.

I'm sure like me, you found that pep talk really inspirational and really mind blowing.

So, um, there's new drugs coming through for HER2 breast cancer, um, and HER2's just been approved.

And we've been working with, um, Daiichi Sankyo that makes that, that drug to, to make it even better.

And there's lots of folks working on triple-negative breast cancer, new treatments coming through for that.

We've had a focus recently.

One pairs ivanescomab with sonacetatugvidotin, a CLDN18.2-directed antibody drug conjugate that AstraZeneca licenses globally from KYM Biosciences.

The other, which AstraZeneca and Daiichi Sankyo entered with Summit, pairs it with Datraway in several tumors, including lung and breast cancer.

Those trials are where clinical evidence will come from.

The closing itself reported no efficacy result.

The comparison was with placebo, not Ibrance maintenance.

Nor was tucatinib tested against Daiichi Sankyo's and HER2, which FDA approved with pertuzumab last December as a first-line treatment.

And HER2's trial started counting at first-line treatment.

Tucatinib started only after induction with the antibodies and a taxane.

Merck & Co features this week, but not in ways its executives might prefer.

The US giant is facing setbacks for two drugs, firstly for the B7H3-targeting ADC iphenatomab deroxtecan partnered with Daiichi Sankyo, after the US FDA found insufficient data in an approval filing to support accelerated approval for extensive-stage small-cell lung cancer, leading Merck to withdraw the application.

Merck has also voluntarily withdrawn from the market after six years its hospital antibiotic, Recarbio, following poor sales and marking another big pharma exit from the anti-infective space.

Elsewhere this week, Scrip reported on the intensifying race to shake up the market for wet age-related macular degeneration, Roche's reset of its pipeline to ensure future growth, and how Lilly and mid-sized pharma firms are setting the increased pace for M&A so far this year.

The anti-HER3-ADC patritumab diruxtacan was voluntarily withdrawn in May 2025 after it was rejected by the US agency in 2024 for use in locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.

This drug is still in development at phase 3 for breast cancer and phase 2 for a range of tumour types.

Merck and Daiichi Sankyo had hoped that IDXD would become the first ADC directed against B7H3 to reach the market, but the product has plenty of competition in this space.

For example, HANSO and GSK's Rizvutatog rezitacan has just significantly extended survival in the Phase 3 China-only Artemis 008 trial in advanced or relapsed SCLC patients, leading analysts to hail it as a potential next standard of care in second-line treatment.

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This activity is supported by an educational grant from AbbVie Incorporated, AstraZeneca, and Daiichi Sankyo.

Hello, my name is Rithi Salani.

I'm a GYN oncologist at UCLA in Los Angeles, California.