Pembrolizumab for Esophageal or Gastroesophageal Junction Carcinoma: Ken Kato, MD, PhD

Recently, the FDA approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) carcinoma who do not qualify for surgical resection or definitive chemoradiation. The approval was based on the results of KEYNOTE-590, a phase 3 trial that demonstrated significant improvements in progression-free survival and overall survival for patient...

Sacituzumab Govitecan Granted Regular Approval for Triple-Negative Breast Cancer

The FDA has granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who previously have been treated with two or more systemic therapies, at least one of them for metastatic disease. Previously, the FDA had granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the ASCENT study (NCT0257445...

Addressing Gaps in Knowledge of the Optimal Approach to Managing Myelofibrosis

Myeloproliferative neoplasms, including myelofibrosis, polycythemia vera, and essential thrombocytopenia, affect approximately 13,000, 134,000, and 148,000 individuals in the United States, respectively. Due to difficulties in identifying the disease, low disease prevalence, a complicated symptom profile, differences in patient and provider perspectives regarding symptom burden and treatment goals, and a lack of effective and tolerable therapies, there is confusion over the optimal approach to t...

Nivolumab/Cabozantinib for Renal Cell Carcinoma: David Braun, MD, PhD, and Wenxin (Vincent) Xu, MD

Recently, the results of a phase 3 trial on nivolumab/cabozantinib were published in the New England Journal of Medicine. The study (CheckMate 9ER) compared the efficacy and safety of nivolumab/cabozantinib with those of sunitinib in adult patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The trial results demonstrated that nivolumab/cabozantinib has significant benefits over sunitinib in this patient population. In this interview with Oncology Data Advisor, Dr. ...

Daunorubicin/Cytarabine Approved for Secondary Acute Myeloid Leukemia in Pediatric Patients

The FDA has approved daunorubicin and cytarabine (Vyxeos®, Jazz Pharmaceuticals) for pediatric patients one year and older with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes. "Effective regimens are needed for children with relapsed acute myeloid leukemia (AML)," wrote Todd Cooper, DO, of Seattle Children's Hospital, and colleagues, in their May publication in the Journal of Clinical Oncology of AAML1421 (NCT02642965), one of the studie...

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