Pembrolizumab Approved for Merkel Cell Carcinoma

Previously approved for the treatment of several other cancers, including lung, cervical, gastric, liver, head and neck, bladder, and certain types of lymphoma, pembrolizumab (Keytruda®, Merck & Co., Inc.) is now approved for both adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), a rare skin cancer affecting about 2,000 patients per year. Merkel cell carcinoma is aggressive and challenging to treat, and patients with advanced disease have...
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Venetoclax Combination Approved for Acute Myeloid Leukemia

The FDA has approved venetoclax (VenclextaÒ, AbbVie Inc. and Genentech Inc.) to be used in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of acute myeloid leukemia (AML) in elderly patients or those ineligible for intensive chemotherapy. Approval of venetoclax was determined based on two open-label, non-randomized trials involving patients with newly diagnosed AML aged 75 years or older or with comorbidities that prevent them from receiving intensive induction...
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Lorlatinib Approved for ALK-Positive Metastatic NSCLC

Lorlatinib (Lorbrena®, Pfizer, Inc.) is approved as second- or third-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. FDA approval was granted based on a non-randomized, dose-ranging and activity-estimating, ...
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