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Oncology Newsfeed

  • FDA Approves Daratumumab in Combo for Multiple Myeloma Ineligible for ASCT

    On June 27, the  U.S. Food and Drug Administration (FDA) announced approval of daratumumab (Darzalex®) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

    Read FDA announcement. 


  • FDA Approves Bevacizumab-bvzr (Zirabev™) Avastin Biosimilar

    On June 28, Pfizer Inc. announced that the U.S. Food and Drug Administration(FDA) has approved Zirvabev™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

    Read corporate press release.

    Posted 6/28/2019


  • Senate HELP Committee Adds More Drug Pricing Reform Measures to S.1895

    On June 25, the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee leaders added bipartisan legislation to S. 1895 (116), the Lower Health Care Costs Act. In marking up the bill, legislators are expected to incorporate large-scale proposals to tackle drug pricing reform from Congress, including, surprise medical billing legislation, telehealth access legislation, generics competition legislation, and a tobacco 21 proposal.

    Posted 6/25/2019



  • President Trump Signs Executive Order Requiring Healthcare Price Disclosure

    On Monday, President Trump signed an executive order that aims to make hospital and other healthcare cost more transparent for consumers.

    The order calls for health officials to propose a regulation within 60 days that would ultimately require hospitals and hospital-employed physicians to post their charges — including the discounted rates they negotiate with insurers.

    Read Executive Order.

    Posted 6/25/2019


  • FDA Approves Pembrolizumab for Metastatic SCLC

    On June 17, 2019, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

    Read FDA announcement.

    Posted 6/18/2019


  • FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications

    On June 13, 2019, Amgen and Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved Kanjinti™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

    Read corporate press release.

    Posted 6/14/2019


  • ACCC Joins In Comment Letter on Medicare NGS NCD

    The Association of Community Cancer Centers (ACCC) has joined with oncology stakeholder organizations in a comment letter to the Centers for Medicare & Medicaid Services (CMS) on National Coverage Determination (NCD) 90.2 for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R).

    Section 90.2 of NCD describes conditions of coverage for NGS. The section is being interpreted to apply to NGS tests for somatic and germline mutations. Additionally, Section 90.2 of the NCD states criteria that patients must meet to qualify for NGS testing, and stipulates specific requirements that the diagnostic laboratory test using NGS must meet.

    The comment letter to CMS cites specific concerns regarding the potentially deleterious effect of the Section 90.2 NCD on access to germline testing. The stakeholder letter recommends to CMS "that NCD 90.2 be revised to indicate that NGS-based germline genetic tests are exempt from the policy. This National Coverage Determination should specifically apply to somatic mutation testing and be renamed:

    National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS) for Somatic."

    Read the comment letter.


  • ACCC Joins In Support for S. 946, Legislation to Improve Access to Clinical Trials

    The Association of Community Cancer Centers (ACCC) joined the American Cancer Society Cancer Action Network, the American Lung Association, the American Society of Clinical Oncology, the Cancer Support Community, and a number of other oncology clinical, professional, and patient advocacy organizations in a June 6, letter of support for S. 946, the Henrietta Lacks Enhancing Cancer Research Act of 2019.

    The legislation is aimed at eliminating barriers in patient access to cancer clinical trials, with a special emphasis on decreasing disparities in cancer clinical trials. 

    Read the letter.



  • FDA Approves Polatuzumab Vedotin-piiq + BR for Diffuse Large B-Cell Lymphoma

    On June 10, Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to polatuzumab vedotin-piiq (PolivyTM) in combination with bendamustine plus rituximab (BR) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received at least two prior therapies. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

    Read the Genentech press release.

    Posted 6/10/2019


  • MA Prior Auth Bill Would Simplify Process; Increase Transparency

    On Wednesday, June 5, a bipartisan group of legislators introduced the “Improving Seniors’ Timely Access to Care Act of 2019” (H.R. 3107).  The bill would require the Centers for Medicare & Medicaid Services (CMS) to regulate the use of prior authorizations by Medicare Advantage (MA) plans in order to streamline the current MA prior authorization system.

    The bill also calls for increased transparency in the prior authorization process and would require MA plans to report the extent of their prior authorization use to CMS, as well as their rate of approvals or denials. 

    Cosponsors of the bipartisan bill include Rep. Roger Marshall, MD (R-Kan.), Rep. Mike Kelly (R-Pa.), Rep. Ami Bera, MD (D-Calif.), and Rep. Suzan DelBene (D-Wash.).

    Posted 6/6/2019