The FDA has approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro™, Aadi Bioscience) for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor. "Malignant perivascular epithelioid cell tumor is a rare, aggressive sarcoma," wrote Andrew J. Wagner, MD, PhD, Medical Director of Ambulatory Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School, and colleagues, in t...

The FDA has approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy with resection of metastatic lesions."Patients with renal cell carcinoma who undergo nephrectomy [had] no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence [prior to this approval]," wrote Toni K. Choueiri, MD, Director of the Ki...

Within the last few years, treatment of renal cell carcinoma has improved dramatically, with FDA approvals of several agents and numerous others in development. In this interview, Bradley McGregor, MD, Clinical Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and an Instructor in Medicine at Harvard Medical School, highlights these exciting developments and sheds light on the additional progress that is underway for the treatment of renal cell carcinoma. Onc...

The FDA has granted approval to belumosudil (Rezurock™, Kadmon Pharmaceuticals, LLC), for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. "Belumosudil (KD025) is a novel oral selective Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor specifically designed for the treatment of chronic GVHD," wrote Corey S. Cutler, MD, MPH, FRCPC, Medical Director of the Adult Stem Cell Transplantation...

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. ...

The FDA has approved idecabtagene vicleucel (Abecma®, Bristol Myers Squibb) for patients with relapsed or refractory multiple myeloma who have already been treated with four or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. "Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic ef...

The FDA has granted accelerated approval to axicabtagene ciloleucel (Yescarta®, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent. An indolent form of non-Hodgkin lymphoma (NHL) that is not generally curable, FL is considered a chronic disease. Therefore, people living with FL often require second-line therapies after their di...

The FDA has approved melphalan flufenamide (Pepaxto®, Oncopeptides AB) in combination with dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy and whose disease is refractory to at least one CD38–directed monoclonal antibody, one proteasome inhibitor, and one immunomodulatory agent. "Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapid...

The FDA has approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with cabozantinib (Cabometyx®, Exelixis) for patients with advanced renal cell carcinoma (RCC) receiving their first line of therapy. "As monotherapies, nivolumab and cabozantinib have demonstrated efficacy and a manageable safety profile in advanced RCC," wrote Toni Choueiri, MD, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and colleagues in their abstract of results from the...

The FDA has recently expanded approval for selinexor (XpovioTM, Karyopharm Therapeutics) to include combination therapy with bortezomib and dexamethasone for adults with multiple myeloma who have received at least one previous line of therapy. Previously, selinexor was approved in combination with dexamethasone for patients with multiple myeloma who have received four previous lines of therapy, including two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal...

In the neoadjuvant setting, nivolumab alone and in combination with ipilimumab is effective and tolerable for patients with previously untreated squamous cell carcinoma (SCC) of the oral cavity, according to results of a phase 2 trial. Surgical resection followed by adjuvant treatment is the standard of care for locally advanced oral cavity SCC. However, immunotherapies such as nivolumab and ipilimumab have recently demonstrated potential for tumor debulking in the neoadjuvant setting, thereby i...

In this interview with i3 Health, Eric P. Winer, MD, discusses tucatinib (TukysaTM, Seattle Genetics), recently approved by the FDA in combination with trastuzumab and capecitabine for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer previously treated with at least one anti-HER2­–based regimen in the metastatic setting. Dr. Winer, principal investigator of the phase 3 HER2CLIMB trial, on which the approval was based, discusses tucat...

The FDA recently granted approval to sacituzumab govitecan-hziy (Trodelvy™, Immunomedics, Inc) for patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies. Approval was based on a clinical trial (NCT01631552) that enrolled 108 patients with metastatic TNBC. In an interview with i3 Health, Sara Tolaney, MD, MPH, one of the study authors, provides insights on treating TNBC and the significance of the sacituzumab govitecan approval. What are the ...

In the midst of the COVID-19 pandemic, cancer survivors face heightened physical and psychosocial challenges, as well as barriers to health care delivery. The authors of an editorial recently published in the Journal of Cancer Survivorship have provided specific suggestions as to how health care workers involved in cancer care can help to address cancer survivors' needs during this difficult time. "The recent COVID-19 pandemic has affected the world and has the potential to disproportionately af...

Earlier this month, ​the FDA approved isatuximab-irfc (Sarclisa​®​, Sanofi), an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least two prior lines of treatment, including lenalidomide and a proteasome inhibitor. In this interview with i3 Health, Paul G. Richardson, MD, who served as the co-primary investigator of the ICARIA-MM study, on which the isatuximab approval was based, shares his thoughts on the si...

Patients with hormone receptor (HR)-positive metastatic breast cancer are typically treated with endocrine therapy. However, patients with mutations in the genes PIK3CA and ESR1 usually develop resistance to endocrine therapy. To discover ways to effectively identify PIK3CA and ESR1 mutations in patients with HR-positive metastatic breast cancer and predict treatment outcomes, researchers at Stanford University evaluated the efficacy of using liquid biopsies compared with solid tumor biopsies to...

Pembrolizumab (Keytruda®, Merck) has received accelerated FDA approval for patients with metastatic small cell lung cancer (SCLC) experiencing disease progression during or after platinum-based chemotherapy following at least one other previous line of therapy. Metastatic SCLC, or extensive-stage SCLC, comprises around 15% of all lung cancers and occurs primarily in heavy smokers. It carries a dismal outlook; only 5% of patients with extensive-stage SCLC live for two years after diagnosis. Appro...

A phase 2 clinical trial assessing the feasibility of adjuvant palbociclib (Ibrance®, Pfizer) and endocrine therapy for patients with early breast cancer reports that it is an effective treatment for these patients. Palbociclib, a targeted therapy drug that inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), causes the cancerous cells to stop dividing and reproducing, ultimately stopping cancer growth. This drug has already been approved for advanced metastatic breast cancer. For the study, publ...

Recently, the FDA approved ruxolitinib (Jakafi®, Incyte Corporation), a JAK1/JAK2 inhibitor, for the treatment of steroid-refractory acute graft-versus-host disease (GVHD). A potentially life-threatening condition, GVHD is a complication of allogeneic hematopoietic stem cell transplantation (HSCT), a treatment for hematologic malignancies that is administered following high-intensity chemotherapy or radiation. In this interview with i3 Health, Corey S. Cutler, MD, MPH, FRCPC, Medical Director of...