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FDA Approves Targeted Therapy for Bile Duct Cancer

The Food and Drug Administration (FDA) has approved a targeted therapy called Bizengri (zenocutuzumab) to treat a rare, aggressive bile duct cancer. Bizengri is the first drug approved for people with advanced, unresectable or metastatic neuregulin 1 (NRG1) fusion-positive cholangiocarcinoma who have disease progression after receiving another treatment, Healio reported. The FDA based the approval on results from a phase I/II clinical trial that evaluated Bizengri in people with NRG1 fusion-positive cancers. Among 19 people with NRG1 fusion-positive cholangiocarcinoma, 36.8% had their cancer respond, with responses lasting between 2.8 and 12.9 months. Common side effects included constipation, diarrhea, fatigue, pain, nausea, rash, shortness of breath, swelling and vomiting. Bizengri is the seventh therapy approved via the national priority voucher pilot program, which reduces the time required for the federal government to review a drug’s efficacy. “Patients with this ultra-rare type of cancer desperately need new treatment options,” then-FDA Commissioner Marty Makary, who resigned this week, said in a statement. “Through the national priority voucher pilot program, the FDA is accelerating therapies for rare diseases with unmet medical needs, reviewing applications in significantly shortened timelines.” Bizengri has already received accelerated approval for advanced, unresectable or metastatic NRG1 fusion-positive pancreatic and non-small cell lung cancers.

Older Adults With Metastatic Lung Cancer Often Do Not Receive Systemic Treatment

Less than half of people 65 and older diagnosed with metastatic non-small cell lung cancer (NSCLC) receive systemic treatment, according to a study published in JAMA Oncology. Researchers analyzed health and Medicare claims data for 254,611 people age 65 or older diagnosed with stage IV NSCLC between 2006 and 2021. They found 46.8% of people received systemic treatment, such as chemotherapy, immunotherapy or targeted therapy. Researchers noted 39.8% of people died within three months of diagnosis, so they may have been too sick to receive treatment, the New York Times reported. Additionally, 33.4% of people did not see an oncologist. Those who saw an oncologist were more likely to receive systemic treatment. Black and Hispanic patients and people who lived in rural areas or were unmarried were less likely to receive treatment. Patients may not seek treatment due to difficulty affording care or transportation or because they feel shame, as people who smoked cigarettes often feel responsible for developing lung cancer, the Times reported. Also, some patients may not seek treatment because they still view a stage IV lung cancer diagnosis as a death sentence. However, thanks to advances in recent decades, immunotherapies and targeted therapies can help control disease for extended periods with fewer side effects than chemotherapy. “The fact that so many older adults are not getting treatment is really, really sobering,” Carolyn J. Presley, a medical oncologist who specializes in lung cancer at Ohio State University Comprehensive Cancer Center in Columbus and was not involved in the study, told the Times.

Metastatic Breast Cancer Rates Rising in the US

The number of stage IV breast cancer cases diagnosed each year in the U.S. increased from 2010 to 2021, according to a study published in JAMA Network Open. Using national cancer surveillance data, researchers analyzed 761,471 breast cancer cases diagnosed during that period. Of those cases, 5.8% were de novo metastatic breast cancer, meaning the cancer was stage IV when it was first diagnosed, MedPage Today reported. They found there were 11.2 cases of stage IV breast cancer for every 100,000 women in the U.S. population in 2021, up from 9.5 cases in 2010. Rates among men also rose from 0.12 cases per 100,000 men in 2010 to 0.2 cases in 2021. Metastatic breast cancer incidence increased across all age and racial groups. “Prior analyses reported stable stage IV incidence before 2010 despite screening expansion,” José P. Leon, a medical oncologist at Dana-Farber Cancer Institute in Boston, and colleagues wrote in the study. “In contrast, our findings demonstrate a significant increase beginning in 2010, including among screening-eligible age groups. The underlying drivers remain uncertain and may reflect population-level changes in risk factors, screening patterns, or access to care.” Additionally, the study found overall survival for people with stage IV breast cancer increased for each successive year from 2010 to 2021. In an accompanying commentary, Laura C. Pinheiro, a cancer prevention researcher at Weill Cornell Medicine’s Sandra and Edward Meyer Cancer Center in New York City, wrote that the results highlight the growing need to support metastatic breast cancer survivors. “Given the tremendous physical, psychosocial and financial burden experienced by these patients, we should prioritize supporting adults with advanced cancer throughout the cancer care continuum,” she wrote.