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Showing 1 - 8FDA Approves Cemiplimab-rwlc for Metastatic Cutaneous Squamous Cell Carcinoma
On September 28, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (SCC) or locally advanced cutaneous SCC who are not candidates for curative surgery or...
FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a programmed cell...
FDA Approves Cobimetinib in Combination With Vemurafenib for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) approved cobimetinib (Cotellic) to be used in combination with vemurafenib (Zelboraf) to treat metastatic or unresectable melanoma, with the BRAF V600E or V600K mutation. “As we continue to advance our knowledge of tumor biology, we have...
FDA Approves Adjuvant Ipilimumab to Reduce the Risk of Melanoma Returning After Surgery
The U.S. Food and Drug Administration has expanded the approved use of ipilimumab (Yervoy) to include a new use as adjuvant therapy for patients who have cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm and have undergone complete resection, including total...
FDA Approves Nivolumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a PD-1 inhibitor, is intended for patients who have been previously treated with ipilimumab...
FDA Approves Pembrolizumab for Advanced Melanoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to the anti–PD-1 antibody pembrolizumab (Keytruda) for the treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Pembrolizumab is intended for use following...
FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer
The U.S. Food and Drug Administration today approved two new drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with advanced or unresectable melanoma, the most dangerous type of skin cancer. Dabrafenib, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors...
