Benjamin P. Saylor

Benjamin P. Saylor is associate editor of Urology Times, an Advanstar Communications publication.

The FDA approved an additional recommended dosage of 400 mg every 6 weeks for the anti-PD-1 therapy pembrolizumab (Keytruda), across all adult indications, including monotherapy and combination therapy, Merck reported.

This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every 3 weeks, according to Merck.

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Pembrolizumab has a number of genitourinary cancer indications. It is indicated for:

• the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) ≥10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

• 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

• the treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Pembrolizumab, in combination with axitinib, is also indicated for the first-line treatment of patients with advanced renal cell carcinoma.

“The important social distancing measures for COVID-19 have created a number of challenges for people with cancer, including keeping to planned treatment schedules,” said Roy Baynes, MD, PhD, of Merck Research Laboratories. “[The] approval of an every 6-week dosing schedule for KEYTRUDA gives doctors an option to reduce how often patients are at the clinic for their treatment.”

Commenting on the announcement, Arjun Balar, MD, told 

The newly approved dosing provided additional flexibility and convenience for patients, especially for those who have already achieved disease control with treatment and can now enjoy extended times between treatment visits.

“The safety and efficacy profile of every 6 weeks and every 3 weeks dosing should be identical. Therefore, whether you’re choosing every 6 weeks or 3 weeks dosing, it’s important to recognize that vigilance and monitoring for immune-related toxicities should be no different. Keeping in close contact with patients and early intervention for immune-related toxicities is particularly critical,” advised Balar, of NYU Langone Health.

Disclosures: Balar is a consultant/adviser for Genentech, Incyte, Janssen, Merck, Pfizer, AstraZeneca/Medimmune, Nektar, and Seattle Genetics. He has received institutional funding from Genentech, Merck, AstraZeneca/Medimmune, Seattle Genetics, and Immunomedics.

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FDA approves additional recommended dosage for anti-PD-1 therapy

The COVID-19 pandemic presents myriad challenges for urologists, including the implementation of telemedicine, protecting staff and patients, and the postponement of elective procedures. The pandemic’s effect is felt even in the area of recertification. On April 2, J. Brantley Thrasher, MD, executive director of the American Board of Urology, spoke with 

 about what the ABU is doing to reduce the burden on urologists and their practice.

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J. Brantley Thrasher, MD, executive director of the American Board of Urology, spoke with Urology Times about what the ABU is doing to reduce the burden on urologists and their practice.

Dr. Thrasher discusses COVID-19's impact on the ABU, telemedicine, research

® Clinical Practice Board member and blogger, has written thoughtfully and eloquently about the COVID-19 pandemic in recent blog posts for UrologyTimes.com. 

® spoke to him on April 7 about how he and his practice are coping with the present situation.	 	

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Jeb Bush touched on a range of issues in health care and politics and shared a few personal anecdotes about his famous family with LUGPA members at the association’s 

Bush, the 66-year-old former governor of Florida, said the agency that runs the Medicare program is doing good work under “clouds of chaos,” agreed with site-neutral payments for hospital systems and independent practices, strongly disagreed with Medicare for All, and admitted disappointment over the Republican’s party’s “paralysis” on health care policy. Throughout his speech and a question-and-answer session that followed, he decried the lack of civility in modern politics.

He was warmly received by LUGPA urologists and practice administrators, who along with the association’s Health Policy and Political Affairs Team, were provided an opportunity to pose questions. Select questions and responses follow.

Hospital systems have amazing political clout that enables them to drive policy that creates inefficiencies. How do we impress upon the politicians that are going to be inundated with really deep pockets and have influence on their voters to do the right thing when it comes to the health care playing field?

"I totally get it," Bush said, citing his own state as an example of rapid consolidation of health care systems. "The subject of focusing on the sole practitioner or the small businessperson at the expense of these monopolistic kinds of structures should have bipartisan support. It's hard to make an argument if you have 80% of the commercial insurance market as a hospital, that you have to go to them at a higher price. That's not a liberal idea or a conservative idea, that's just a bad idea."

What can be done so that politicians are emboldened to do the right thing, as opposed to fostering tribalism?

"Part of it is you can make structural changes, campaign finance reform, redistricting. If the Democrats have a blue wave election in 2020, they'll draw the maps in the states in 2022. They're going to look dramatically different," Bush said.

The other part, Bush said, is for politicians from both parties to interact with each another.

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"Reconnecting on a human level would be helpful. This is not a problem in Tallahassee. It's not a problem in New York or in most other places. Politics is rough and tumble, and the legislative process has got a lot of dynamics to it that create a lot of tension and anger and emotion. But people respect each other because they're with them all the time."

Michael Bloomberg is mulling another run for president. Does he have a chance of uniting people?

Bush referred to Bloomberg as "an extraordinary man."

"He is no nonsense. He doesn't suffer fools. He's pretty self-assured, incredibly successful, very generous, very practical," Bush said.

Regarding Bloomberg's viability as a presidential candidate, however, Bush said, "He's an incredible guy, but I just don't think competency and being a successful billionaire is necessarily a winning strategy in a hyper-partisan Democratic primary. It may have some appeal.”

“The strange thing is that if it's a Warren-Trump race, there's a massive group in the middle that's yearning for something that's a little more stable. I think there are people who yearn for stability and civility, and that yearning may trump their own ideological views; they'd be willing to give up some of their positions on things to just get back to normalcy where things can get done."

You said that if John McCain had voted for the Republican health care reform measure, it really wouldn't have accomplished very much. Who on the Republican side represents the thought leaders for an alternative to Medicare for All and substantive health care policy making?

"To be honest with you, I don't know. I'm sure there are people," Bush said. "Generally Republicans... don't want to keep going back to the same thing that they failed to do. So they're letting it lie.

"The people that seem to be most anxious to reform are the people inside of HHS. I've been really impressed with Seema Verma," he said, referring to the current CMS administrator. "She's a real deal."

Bush said much of health policy belongs in the hands of the states, not the federal government.

"Now pharma drug pricing wouldn't necessarily be one of those because that's a federal responsibility. But if you want a flourishing policy area, trust states to be able to do a better job than Washington."

In conservative Florida, Bush said, the legislature passed a bill to allow for reimportation of drugs from Canada. "I think there could be support allowing Medicare to be able to negotiate directly for their for their drugs. Even if it's a pilot to test it, think you're going to find there would be significantly lower drug prices," he said. "What you don't want to do is the Stalin approach, which means there will be no more new drugs. That's the last thing we need to do."

In Texas, the court may uphold overturning the pre-existing condition component of the Affordable Care Act, which we continue to hear is imminent. This could put yet another health care issue on the table for next year's election. Can you comment?

"If it does, I think because of the paralysis inside the Republican policy infrastructure in Washington on health care," Bush said. "I may be maybe slightly wrong on this, but that would be to the advantage of Democrats. There are 100 ideas Republicans have come up with on health care, there's not one. Because of that, no one really thinks Republicans have an alternative, and they don't. There's not one comprehensive approach if Obamacare is turned upside down, which is a shame.

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"Medicaid should be a state run program," Bush added. "And there should be 50 different versions of how Medicaid works with a baseline of basic services available. Our populations are different in every place. Rural people have different issues than people living in the urban core. And our system works better, I think, in a federalist model.

"I'm for them," Bush said. He pointed out that Florida passed term limits in 1992 with 75% to 80% of the vote, and they were implemented in his first year as governor. "In most places where there are term limits, there's no there's no sense of entitlement about the job," he said. "This should be about service, not about a profession. And I think in Washington, it's become more of a profession, sadly."

Bush praised his wife, Columba, to whom he's been married for nearly 46 years. "She's allowed me to pursue my dreams of public service a few times," he said. "To honor her, the last time last time I did it was the last time I'll do it."

Jeb Bush touched on a range of issues in health care and politics and shared a few personal anecdotes about his famous family with LUGPA members at the association’s annual meeting in Chicago.

Author | Benjamin P. Saylor

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FDA approves additional recommended dosage for anti-PD-1 therapy

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