Biologics

FDA OKs Imfinzi + Padcev for Bladder Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Pfizer and Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after radical cystectomy (RC), for treating adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for or who have refused cisplatin based chemotherapy.

Approval was based on data from the VOLGA trial (NCT04960709), a randomized, open-label trial in 695 patients with MIBC, according to FDA. The major efficacy outcome measure was event-free survival (EFS) by blinded independent central review assessment. Overall survival (OS) was an additional efficacy outcome measure.

“The trial demonstrated statistically significant improvements in both EFS and OS for durvalumab/enfortumab vedotin-ejfv compared to RC alone,” the agency says. “Median EFS was not reached (NR) (95% CI: 33.2, NR) in the durvalumab/enfortumab vedotin-ejfv arm and was 12.1 months (95% CI: 7.6, 27.0) in the RC alone arm… Median OS was not reached in either the durvalumab/enfortumab vedotin-ejfv arm or the RC alone arm.”

The most common adverse reactions for durvalumab in combination with enfortumab vedotin-ejfv were increased AST, increased ALT, decreased hemoglobin, rash, increased creatinine, pruritus, decreased calcium, increased lipase, increased potassium, urinary tract infection, increased amylase, fatigue, decreased sodium, decreased lymphocytes, diarrhea, decreased leukocytes, constipation, decreased appetite, increased alkaline phosphatase, dysgeusia, nausea, peripheral neuropathy, musculoskeletal pain, and alopecia.

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FDA OKs Imfinzi + Padcev for Bladder Cancer

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