Clinical News

FDA Approves 2 New Biosimilars for Patients with Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On May 15, 2018, the FDA approved epoetin alfa-epbx (Retacrit; Pfizer) as the first biosimilar to epo­etin alfa (Epogen, Procrit; Amgen) for the treatment of anemia caused by chronic kidney disease, myelosuppressive chemotherapy, or the use of zidovudine in patients with HIV. The new biosimilar is also approved to reduce the need for allogeneic red blood cell transfusions in patients at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. [ Read More ]

Bevacizumab plus Chemotherapy Approved for Several Types of Ovarian Cancer

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On June 13, 2018, the FDA approved bevacizumab (Avastin; Genentech), in combination with carboplatin and paclitaxel, for the treatment of patients with resected, stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, to be followed with beva­cizumab monotherapy. Bevacizumab received orphan drug designation for this indication. [ Read More ]

Keytruda Receives 2 New Indications: Metastatic Cervical Cancer and Relapsed Mediastinal Large B-Cell Lymphoma

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On June 12, 2018, the FDA granted accelerated approval to pembrolizumab (Keytruda; Merck) for patients with recurrent or metastatic cervical cancer that progressed during or after chemotherapy and whose tumors express PD-L1, as determined by an FDA-approved test. Concurrently, the FDA approved the PD-L1 IHC 22C3 pharmDx kit as a companion diagnostic test for determining the PD-L1 status in this patient population. [ Read More ]

Kymriah Approved for Adults with Relapsed or Refractory Large B-Cell Lymphoma

August 2018, Vol 8, No 8 - FDA Approvals, News & Updates

On May 1, 2018, the FDA approved a new indication for the immunotherapy tisagenlecleucel (Kym­riah; Novartis), a CD19-directed, autologous T-cell gene therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma for use after ≥2 systemic therapies, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma. [ Read More ]

Top 4 Trends That Are Changing Oncology Practices

Gail Thompson

August 2018, Vol 8, No 8 - Practice Management

What are the most note­worthy trends that can affect an oncology practice’s strategic planning, budgeting, and bottom line? The Association of Community Cancer Centers (ACCC) partnered with the Advisory Board Company to identify some of those trends in the 2017 Trending Now in Cancer Care Survey. The survey results were presented at the 2018 ACCC Annual Meeting & Cancer Center Business Summit. [ Read More ]

Healthcare Providers and Underserved Populations Need Information About Clinical Trials and Biobanking

Phoebe Starr

June 2018, Vol 8, No 6 - Clinical Trials, Health Disparities

People from lower socioeconomic backgrounds, minority groups, and rural areas are not well-represented in clinical trials and biobanking, which hampers research on health disparities. Patients in these subgroups are willing to enroll in clinical trials, but they are often not asked to participate, and neither they nor their healthcare providers are well-informed about this important research. [ Read More ]

Tagrisso Now Approved as First-Line Therapy for Patients with Metastatic NSCLC and EGFR Mutations

May 2018, Vol 8, No 5 - FDA Approvals, News & Updates

On April 18, 2018, the FDA approved osimertinib (Tagrisso; AstraZeneca Pharmaceuticals) as first-line treatment for patients with metastatic non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA used its priority review process, and designated osimertinib as a breakthrough therapy for this indication. [ Read More ]