Pembrolizumab Approved for Classical Hodgkin Lymphoma

PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen...
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FDA Issues Draft Guidances for Bladder Cancer, Renal Cell Carcinoma

The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical trials concerning eligibility criteria, methodology, and use of disease-free survival as an end point. "The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer, including hosting a public workshop in p...
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Avelumab for Urothelial Carcinoma: An Interview With Thomas Powles, MBBS, MRCP, MD

The FDA recently approved avelumab (Bavencio®, EMD Serono, Inc.) for patients with advanced urothelial carcinoma (UC). Thomas Powles, MBBS, MRCP, MD, discusses with i3 Health the implication of this approval and future steps for research and offers community oncologists advice on treating this patient population. What are the most challenging aspects of treating patients with locally advanced or metastatic UC? Thomas Powles, MBBS, MRCP, MD: The overall survival outcomes are poor for the disease....
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FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...
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Selinexor Approved for R/R Diffuse Large B-Cell Lymphoma

Accelerated approval was granted to selinexor (Xpovio®, Karyopharm Therapeutics) to treat adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including those with DLBCL resulting from follicular lymphoma, after receiving at least two prior lines of systemic therapy. Selinexor had previously been approved in combination with dexamethasone for adult patients with R/R multiple myeloma who were previously treated with at least four therapies and whose disease is refr...
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