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Lead Researcher Discusses FDA Approval of Pembrolizumab for Urothelial Carcinoma

Danielle Bucco
Published: Monday, May 22, 2017

Arjun V. Balar, MD

Arjun V. Balar, MD

The FDA approval of pembrolizumab (Keytruda) for the first-line and second-line setting has delivered yet another new immunotherapy option for patients with metastatic urothelial carcinoma.

The PD-1 inhibitor was specifically approved in the second-line setting for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In the frontline setting, the FDA granted an accelerated approval to frontline pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Pembrolizumab joined other approved immunotherapy agents in the urothelial carcinoma armamentarium, including avelumab (Bavencio), durvalumab (Imfinzi), atezolizumab (Tecentriq), and nivolumab (Opdivo).

In an interview with OncLive, Arjun V. Balar, MD, a lead investigator on pivotal pembrolizumab research in bladder cancer, and an assistant professor, Department of Medicine, and director, Genitourinary Medical Oncology Program, NYU's Perlmutter Cancer Center, discussed the impact of the approval of pembrolizumab and other immunotherapy agents in urothelial carcinoma, as well as the next steps with these treatments.

OncLive: Can you discuss the significance of the recent FDA approval of pembrolizumab in bladder cancer?

Balar: It comes down to which approval we’re talking about, whether it is the second line or the first line. For the second line, at that point, pembrolizumab becomes the 5th drug approved for the second-line treatment of bladder cancer. From that perspective, it adds to our armamentarium in terms of options that we can provide our patients. It's similar in terms of the class of drug. It’s a PD-1 antibody, allowing it to work on the PD-1 axis, making the response and safety very similar to other agents in its class. 

What's unique about pembrolizumab in the second-line setting is that it was approved on the basis of a randomized phase III trial that definitively demonstrated its improved survival versus standard of care chemotherapy, which no other agent in this class has been able to do. In my opinion, that is probably the strongest level of evidence for any of the drugs. I think that is particularly unique in the second-line setting. 

In terms of the frontline setting, pembrolizumab is now just 1 of 2 drugs that is approved for patients who are ineligible for cisplatin. In this case, these are both accelerated approvals, whereas pembrolizumab’s second-line approval is a full approval. Both accelerated approvals are on the basis of response and durability of responses in the first-line setting. 




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Online CME Activities
TitleExpiration DateCME Credits
Clinical Interchange™: Translating Research to Inform Changing Paradigms: Assessment of Emerging Immuno-Oncology Strategies and Combinations across Lung, Head and Neck, and Bladder CancersOct 31, 20182.0
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