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FDA Approves Combination Treatment for Advanced Bladder Cancer

The Food and Drug Administration (FDA) on April 3 granted accelerated approval to a treatment regimen for patients with urothelial carcinoma, the most common form of bladder cancer. Padcev (enfortumab vedotin) can now be used with Keytruda (pembrolizumab) as a first-line therapy for patients with locally advanced or metastatic disease who cannot take cisplatin chemotherapy. The accelerated approval was based on interim results from a phase I/II clinical trial, OncLive reported. In trial cohorts involving 121 patients with bladder cancer, 68% of participants had an objective response to the medication, with 12% exhibiting no evidence of disease after treatment. “This patient population now has an additional treatment option to treat advanced bladder cancer at first diagnosis of metastatic disease,” Ahsan Arozullah, head of oncology development at Padcev’s manufacturer, Astellas, said in a press release. Common side effects included fatigue, rash, peripheral neuropathy and increased glucose levels. This combination treatment’s effectiveness will be further examined in a phase III clinical trial before the FDA considers granting full approval.

Judge’s Ruling Could Eliminate Coverage for Several Cancer Screenings

A federal judge has struck down the portion of the Affordable Care Act that required insurance companies to offer several preventive care services—including some cancer screenings—at no cost to patients. In his March 30 decision, U.S. District Court Judge Reed O’Connor ruled that requiring coverage for any services recommended by the U.S. Preventive Services Task Force (USPSTF) since 2010 is unconstitutional because USPSTF members are not appointed by the president or confirmed by the U.S. Senate, Kaiser Health News reported. Among these USPSTF recommendations are colorectal cancer screenings for people ages 45 to 49 and lung and skin cancer screenings. Under O’Connor’s ruling, patients could be on the hook for a copay or deductible for these services, which experts fear could lead to fewer people receiving screenings. The decision could “ultimately result in more individuals being diagnosed with their cancer at later stages, where our treatments are more toxic, less effective and far, far more expensive,” Craig Bunnell, chief medical officer of the Dana-Farber Cancer Institute in Boston, told NBC News. Many experts say insurance companies are not likely to drop coverage of these services altogether, and no changes could be implemented until new health care plans begin at the start of 2024. The U.S. Justice Department appealed the ruling the day after it was issued, Reuters reported.

Older Cancer Patients Weigh Lifestyle Impact When Considering Aggressive Treatment

For many older patients with slow-growing tumors, it’s unlikely cancer will cause their deaths. “Once I got my arms around it and really understood it wasn’t a death sentence, then next thing I wanted to do was say, ‘OK, how do I maintain my lifestyle?’” Mary Ellen Boyd, an 81-year-old from Connecticut with breast cancer, told the Wall Street Journal. Boyd is among a growing group of older people with cancer choosing less aggressive treatment methods to spare themselves harsh side effects and to limit the impact on their daily lives. “Patients have many more options today than they did even a few years ago,” Jean L. Wright, a radiation oncologist and breast cancer specialist at Johns Hopkins Medicine in Baltimore, told the Journal. This trend toward personalized medicine comes as new evidence shows people can often forgo treatment without impacting their survival. Among prostate cancer patients, some opt for active surveillance instead of surgery and radiation to avoid side effects like erectile dysfunction and incontinence. For those with breast cancer, some decide against radiation following surgery to bypass weeks of appointments and side effects like fatigue and skin irritation. Meanwhile, researchers continue to develop more tests to assess a specific patient’s recurrence risk and determine when aggressive treatment can be avoided or delayed.