• FDA issues complete response letter for retifanlimab for anal cancer

    1 month ago - By Healio

    The FDA issued a complete response letter to Incyte indicating it cannot approve the company's biologics license application that seeks approval of retifanlimab for certain patients with anal cancer.
    The agency determined additional data are needed to demonstrate the clinical benefit of retifanlimab , a PD-1 inhibitor administered via IV.
    Incyte officials will discuss next steps with the FDA, according to a company-issued press release.
    Incyte sought approval of retifanlimab for treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who
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  • Study shows survival benefits of smoking cessation after lung cancer diagnosis

    Study shows survival benefits of smoking cessation after lung cancer diagnosis

    1 month ago - By Healio

    Current smokers with early-stage lung cancer who quit smoking after their diagnosis had improved overall and progression-free survival rates, according to a prospective cohort study.
    To date, studies that investigated whether smoking cessation after a cancer diagnosis might improve patients' chances of survival have only measured smoking status at the time of diagnosis or treatment without follow-up, or had a limited number of smokers and short follow-up, Mahdi Sheikh, MD, PhD, a physician and cancer epidemiologist at WHO's International Agency for Research on Cancer, and colleagues
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  • FDA approves Keytruda for high-risk, early-stage triple-negative breast cancer

    FDA approves Keytruda for high-risk, early-stage triple-negative breast cancer

    1 month ago - By Healio

    The FDA approved pembrolizumab for treatment of patients with high-risk, early-stage triple-negative breast cancer.
    The approval applies to use of pembrolizumab - an anti-PD-1 therapy - with chemotherapy in the neoadjuvant setting, then as monotherapy in the adjuvant setting.
    “Even when triple-negative breast cancer is diagnosed early, 30% to 40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery,” Joyce O'Shaughnessy, MD, chair of breast cancer research at Baylor University Medical Center and Texas
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