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The FDA has issued draft guidance documents for drug and biologic development in the adjuvant treatment of renal cell carcinoma (RCC) and bladder cancer, with recommendations for clinical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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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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Nivolumab Plus Chemotherapy for Gastric/Gastroesophageal Junction Cancer: Kohei Shitara, MD

In advanced gastric cancer and gastroesophageal junction cancer, treatment options remain limited. Results of the phase 3 CheckMate 649 and phase 2/3 ATTRACTION-4 studies, both of which investigated chemotherapy with or without nivolumab in patients with previously untreated unresectable, advanced, or recurrent gastric/gastroesophageal junction (G/GEJ) cancer, were recently presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. CheckMate 649 reported significant impr...
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Daratumumab/Carfilzomib/Dexamethasone for Multiple Myeloma: Meletios A. Dimopoulos, MD

Recently, the FDA approved a new treatment for multiple myeloma previously treated with one to three lines of therapy: daratumumab (Darzalex®, Janssen) in combination with carfilzomib and dexamethasone. In this interview, Meletios Dimopoulos, MD, principal investigator of the phase 3 CANDOR trial, which served as the basis for the approval, speaks with i3 Health regarding the benefits and adverse events of this new therapeutic combination, as well as additional advances in the treatment of relap...
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Melanoma With Brain Metastases: Nivolumab/Ipilimumab Effective

Nivolumab/ipilimumab demonstrates efficacy in patients with melanoma and brain metastases, according to results of the primary analysis of the phase 3 NIBIT-M2 trial, presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020. "Brain metastases represent a high unmet medical need, in which the therapeutic potential of immune-checkpoint(s) is being actively investigated," note the investigators in their presentation abstract, led by Anna Di Giacomo, MD, Associate Director ...
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