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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Nivolumab/Ipilimumab Approved: Malignant Pleural Mesothelioma

The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...
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Delivering Immunotherapeutics Intratumorally: Safe for Treating Cancer?

Intravenous administration of chemotherapy is the conventional method of delivery. However, several issues arise with this method, including insufficient drug penetration into the tumor tissue. Intratumoral injections of immunotherapies directly into the tumor have been a possible solution to this problem, and, according to a recent study, results of which are published in JAMA Network Open, this technique has been found to be a viable option for a variety of histological conditions and target o...
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Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...
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Denosumab Effective for Giant-Cell Tumor of Bone

According to a recent phase 2 study, denosumab is an effective treatment for patients with giant-cell tumor of bone (GCTB). In this study, results of which are published in The Lancet Oncology, 532 adult and skeletally mature adolescent patients with histologically confirmed and radiographically measurable GCTB were enrolled. In order to be eligible, participants had to be at or above the age of 12 years, weigh at least 45 kg, have a Karnofsky performance status of 50% or higher (Eastern Coopera...
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