Pfizer and Merck KGaA secure CHMP recommendation for Bavencio in Europe for first-line maintenance of urothelial carcinoma

pharmafile | December 14, 2020 | News story | Sales and Marketing Bavencio, CHMP, EMA, Merck, Pfizer, pharma, urothelial carcinoma 

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given its recommendation for Pfizer and Merck KGaA’s immunotherapy Bavencio (avelumab) in the treatment of locally advanced or metastatic urothelial carcinoma (UC).

The ruling backed the therapy as a monotherapy for the first‑line maintenance treatment of UC in adult patients who have received platinum-based induction chemotherapy and not seen their disease progress.

According to the drug’s developers, Bavencio is the only immunotherapy to “significantly” extend overall survival in this patient population. Positive Phase 3 data supported this claim, and was used by the CHMP to reach its verdict.

“The prognosis and quality of life for patients with urothelial carcinoma is unacceptably poor. Despite high response rates to first-line platinum-based chemotherapy treatment, which is the current standard of care, it has limited durability and most patients will ultimately experience disease progression within nine months of initiation of treatment,” explained Dr Simon Crabb, Associate Professor in Medical Oncology at University of Southampton.

“Introducing Bavencio as a first-line maintenance treatment after chemotherapy can sustain and extend the benefits of treatment and significantly prolong overall survival, compared to best supportive care, without a detrimental impact on a patient’s quality of life,” he added. “I believe this strategy will now change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma.”

Bladder cancer is the tenth most common cancer worldwide, and UC accounts for around 90% of bladder cancer cases. Europe alone saw almost 200,000 new diagnoses and over 60,000 deaths from the disease in 2018.

The European Commission will now review the CHMP’s decision and is expected to make a final ruling early next year.

Matt Fellows

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