FDA Approves Merck-Pfizer Partnered Urothelial Carcinoma Immunotherapy Drug

Just yesterday, Merck and Pfizer confirmed that the United States Food and Drug Administration has granted accelerated approval to their partnered drug: a fully-human anti-programmed cell death ligand-1 (anti-PD-L1) monoclonal antibody (mAb). This drug goes by the manufactured name avelumab and will be sold under the label Bavencio as a possible treatment for patients who are suffering from locally advanced or metastatic urothelial carcinoma and whose disease has progressed through or after platinum-containing chemotherapy or for those patients whose disease shows progression within 12 months of receiving either neoadjuvant or adjuvant treatment (with platinum-containing chemotherapy).

It may be important to note, too, the US FDA granted the accelerated approval specifically for treating metastatic Merkel cell carcinoma (MCC) only a few months ago.

Liz Barrett, the global president of Pfizer Oncology, comments, “This approval builds on the ongoing clinical development program for Bavencio in Urothelial Carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers.”

This is now the third immunotherapy drug to be approved for the treatment of bladder cancer in only the past month. The first two, of course, include the first-line approval for atezolizumab (for cisplatin-ineligible patients) and the approval of durvalumab (for patients whose cancer continued to progress during or after chemotherapy).
As such, National Cancer Institute’s Andrea Apolo, MD, contributes, “Once urothelial carcinoma progresses after treatment with chemotherapy, the 5-year survival rate is alarmingly low.” The study investigator goes on to say, “Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease.”

It is also important to note that Bavencio being evaluated in the separate Phase III JAVELIN Bladder 100 study, observing how it might work in combination with best supportive care for the maintenance therapy among those patients who have locally advanced or metastatic Urothelial Carcinoma but whose disease has not progressed after the completion of first-line platinum-containing chemotherapy.

This JAVELIN clinical development program involves at least 30 clinical programs. This includes at least nine Phase III trials and at least 5200 patients who have been diagnosed with any of 15 different types of tumor.
Pfizer and Merck KGaA had originally signed this potentially $2.85 billion deal in November 2014.