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Recently, the FDA granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics, Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have previously been treated with two or more systemic therapies, at least one of them for metastatic disease. The FDA had previously granted accelerated approval to sacituzumab govitecan based on the results of the phase 1/2 IMMU-132-01 study (NCT01631552); the phase 3 ASCENT study (NCT02574455)...
Expert Analysis
Melphalan flufenamide, a newly approved peptide-drug conjugate for multiple myeloma, specifically targets chemotherapy to tumor cells like a warhead on a guided missile. In the following interview, Dr. Paul Richardson, the Clinical Program Leader and Director of Clinical Research of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, discusses the use of melflufen (Pepax...
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...
Approximately 3%–8% of patients with newly diagnosed breast cancer have synchronous distant metastases, which are associated with a poor prognosis. Because therapeutic strategies are guided by the status of lymph node metastases, accurate assessment is necessary in order to select the appropriate treatment for different patients. In a study recently published in JAMA Network Open, a team of invest...
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 be...
Recently, the FDA granted approval to lorlatinib (Lorbrena®, Pfizer, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer. This subset of lung cancers defined by their chromosomal rearrangements of the ALK gene are highly sensitive to small-molecule ALK tyrosine kinase inhibitors (TKIs). Lorlatinib is a novel third-generation small-molecule ...
Nearly 50% of cancer survivors are undertreated for chronic pain, a condition which negatively impacts cancer-related outcomes, physical function, and quality of life. Due to the challenges of the opioid crisis, non-pharmacologic alternatives for pain management in cancer survivors are greatly needed. In the randomized PEACE trial, results of which were recently published in JAMA Oncology, investi...
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Practice Patterns
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...
A shortfall in knowledge in the use of biomarkers and patient-related factors for the personalization of treatment for patients with advanced urothelial carcinoma was identified in the baseline data collected from i3 Health's continuing medical education (CME)–approved visiting faculty meeting series titled New Thinking, New Strategies in Advanced Urothelial Carcinoma, led by Arjun V. Balar, MD, A...
When patients with hematological malignancies do not receive referrals for hematopoietic stem cell transplant (HSCT), they may face a risk of poorer outcomes. Common reasons behind this lack of referrals include provider confusion over eligibility criteria for HSCT, overestimation of the risks associated with transplant, and confusion regarding the benefit of HSCT. This educational gap regarding t...
Of all women diagnosed with cancer in the United States, 30% have breast cancer, which is the second-leading cause of cancer death in this group. Many women have benefitted from regular screening as well as earlier and improved treatment; however, 6% of women present with metastatic disease, and 30% with no initial lymph node involvement will develop metastatic disease. Women with metastatic breas...
Prostate cancer is the tumor type with highest incidence in men in the United States. Typically, the first line treatment for progressive disease is androgen deprivation therapy (ADT). However, most men eventually stop responding to ADT treatment and develop castration-resistant prostate cancer (CRPC). The therapeutic options for this highly heterogeneous disease process have expanded to include n...
Immune thrombocytopenia (ITP) is a heterogeneous disorder that involves a shortage of platelets, or thrombocytes, and can result in excessive bruising or bleeding. Diagnosis and treatment are challenging due to the lack of specific diagnostic criteria and the widely varying clinical features: some patients remain asymptomatic, whereas others experience troublesome bruising or even life-threatening...
Noteworthy Headlines
Monday, April 19, 2021
The FDA has granted approval to nivolumab (Opdivo®, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the initial treatment of patients with ...
Friday, April 16, 2021
Melphalan flufenamide, a newly approved peptide-drug conjugate for multiple myeloma, specifically targets chemotherapy to tumor cells like a warhead on a guided missile. In the following interview, Dr...
Thursday, April 15, 2021
Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing ch...
Friday, April 09, 2021
Recently, the FDA approved pembrolizumab (Keytruda®, Merck Sharp & Dohme Corp.) in combination with platinum/fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced es...
Thursday, April 08, 2021
The FDA has granted regular approval to sacituzumab govitecan (Trodelvy®, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNB...
