Clinical News

FDA Commissioner Outlines New Plan to Increase Biosimilars by “Balancing Innovation and Competition”

Eileen Koutnik-Fotopoulos

October 2018, Vol 8, No 10 - Health Policy

FDA Commissioner Scott Gottlieb, MD, has been outspoken about the critical need to reign in drug prices. Biosimilars are crucial for improving patient access to biologic drugs at an affordable cost. Biologics are now key in the treatment of cancer and autoimmune conditions. But cost remains an obstacle to access to drug therapy. [ Read More ]

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 ]

Strategic Planning by Oncology Practices Can Provide a Roadmap to a Thriving Future

Elaine Estes

July 2018, Vol 8, No 7 - Practice Administration, Strategic Planning

Strategic planning for oncology practices is more important today than ever before, with the oncology landscape rapidly evolving, driven by complex issues not encountered previously. For example, the emergence of value-based care has added new layers of complexity to cancer care, because clinical changes associated with team-based care and documentation and data-­tracking requirements are significant. Practices today are also tasked with finding ways to expand patient access to ancillary support services that improve satisfaction and outcomes, while also keeping costs down. [ Read More ]