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Arvinas Aims for FDA Nod on Vepdegestrant, New Breast Cancer Drug

Arvinas seeks FDA approval for vepdegestrant, a new drug targeting breast cancer. With competition heating up, the drug's success may depend on combination therapies.

It's a bottle with a label on it.
It's a bottle with a label on it.

Arvinas Aims for FDA Nod on Vepdegestrant, New Breast Cancer Drug

Arvinas has applied for FDA approval of vepdegestrant, a novel drug for treating breast cancer, with a decision expected by June 2026. This application marks a significant milestone in the development of a new generation of therapies, according to Zoran Rankovic, director of the Centre for Protein Degradation.

The FDA's recent approval of Eli Lilly's Inluriyo (imlunestrant), another orally available SERD drug, intensifies competition in this field. Arvinas' vepdegestrant, a bifunctional protein degrader, is expected to be approved for patients with ESR1 mutations who have previously received hormone-targeting therapies. However, clinical trials did not show vepdegestrant outperforming existing treatments. Arvinas and Pfizer have collaborated on marketing rights for vepdegestrant, with both companies jointly seeking a new partner to bring the drug to market.

Vepdegestrant demonstrated superiority over fulvestrant only in patients with a specific ESR1 mutation. Arvinas has announced a 15% reduction in its workforce, primarily in commercial roles related to vepdegestrant, following a previous 30% cut and the cancellation of two phase 3 trials. The drug will compete against established SERD drugs like AstraZeneca's Faslodex (fulvestrant), but its biggest opportunity lies in combination therapies for breast cancer patients.

Arvinas' vepdegestrant, if approved, will enter a competitive market for breast cancer treatments. Its success may hinge on its use in combination with other drugs, offering hope for improved patient outcomes in the future.

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