Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy

The application aims to allow the use of this combination therapy for all patients with MIBC, regardless of their cisplatin eligibility.

It could potentially broaden the approved use, which was previously limited to cisplatin-ineligible cases.

The submission was based on data from the Phase III EV-304 clinical trial (KEYNOTE-B15), which studied perioperative enfortumab vedotin and pembrolizumab in patients eligible for cisplatin-based chemotherapy.

Under the Prescription Drug User Fee Act, the FDA has set a target action date of 17 August 2026. The FDA grants priority review to medicines that could offer significant treatment advances or fill gaps where few options exist.

Data from the EV-304 trial showed a 47% decrease in the risk of tumour recurrence, progression or death, and a 35% reduction in death risk when compared to standard neoadjuvant gemcitabine and cisplatin chemotherapy.

The pathological complete response (pCR) rate was 55.8% for the combination versus 32.5% in the chemotherapy arm.

The safety profile for the combination was consistent with prior experience, and no new safety signals were observed. Discussions with other global health authorities for potential regulatory filings are ongoing.

Participants received either perioperative enfortumab vedotin and pembrolizumab or neoadjuvant chemotherapy, with curative-intent surgery performed in both groups.

The primary endpoint is event-free survival (EFS), with key secondary endpoints including overall survival (OS) and pCR rate.

Pfizer chief oncology officer Jeff Legos said: “For people with muscle-invasive bladder cancer, surgery is often just the beginning of a long and uncertain journey, with far too many patients seeing their cancer return.

“If approved, perioperative Padcev plus pembrolizumab could meaningfully change that experience, potentially helping patients reduce the risk of recurrence and live longer, regardless of whether they are eligible for cisplatin.”

Earlier this year, Pfizer signed a deal worth up to $530m with US-based vaccine technology company Novavax.

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