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Pfizer immuno-oncology drug wins US approval for bladder cancer

13 May 2017

The green light from the US Food and Drug Administration allows physicians to prescribe the drug for patients with the condition during or after platinum-containing chemotherapy therapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The median time to response was 2 months; median duration of response has not been reached (range 1.4-17.4 months).

In a phase 1, open-label, single-arm, multicenter study, Bavencio demonstrated efficacy and safety for the treatment of 242 patients with locally advanced or metastatic UC.

Bavencio is targeting patients with the disease which progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

PD-L1 expression was evaluable in 84 percent of patients across both cohorts.

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The indication is based on tumor response rate and duration of response.

The median patient age in the ≥13 weeks follow-up group was 68 years (range, 30-89), 72% of patients were male, and 80% were white. Twenty percent of patients had received prior cisplatin and carboplatin-based regimens, 47 percent had only prior cisplatin-based treatment and 32 percent had only prior carboplatin-based treatment.

Patients enrolled in JAVELIN received Bavencio at 10 mg/kg intravenously every two weeks until progression or unacceptable toxicity.

German Merck said the wholesale price for Bavencio based on an average bladder cancer patient will be about $13,000 a month, less than the $15,000 per month AstraZeneca set after its Imfinzi received US approval for bladder cancer a week ago. The most common serious AEs ( 2% of patients) were abdominal pain, dehydration, increased creatinine/renal failure, intestinal obstruction, musculoskeletal pain, pyrexia, urinary tract hemorrhage, and urosepsis.

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Avelumab was temporarily and permanently discontinued due to AEs in 29% and 12% of patients, respectively. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials, according to Pfizer.

Deaths due to adverse events (AEs) occurred in 6% of patients, and serious AEs occurred in 41% of patients.

Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the US.2,3 When the disease has metastasized, the five-year survival rate is approximately 5%.4 Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.

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Pfizer immuno-oncology drug wins US approval for bladder cancer