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Oncology Newsfeed

  • FDA Proposes Policy Changes to Update Mammography Services

    The U.S. Food and Drug Administration issued a proposed rule on March 27 that would make amendments to the regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 that seek to improve the quality of mammography services. The proposed rule would expand the information mammography facilities are required to provide to patients and healthcare professionals to allow for more informed medical decision-making, the agency said in a statement. It also modernizes mammography quality stands and strengthens the FDA’s ability to enforce regulations that apply to the safety and quality of mammography services.

    Under the proposed rule, breast density information would be added to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.

    The amendments would also expand the information provided to healthcare professionals by proposing to codify three additional categories for the assessments of mammograms, including adding an important category titled “known biopsy proven malignancy,” which would help identify for healthcare professionals those cases where cancer being mammographically evaluated for therapy are already known and identified.

    Under the proposed regulations, both healthcare professionals and patients would receive in their reports and lay summary letters more detailed identifying information about the mammography facility to aid in post-exam communications, the agency said.

    The proposed rule will be open for public comment for 90 days after publication.

    Read the FDA press release.
    View the proposed rule.

    Posted 3/27/2019

  • FDA Approves Atezolizumab for Small Cell Lung Cancer

    On March 19, the FDA approved atezolizumab (Tecentriq®, Genentech) in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

    Read the Roche press release here.
    Read the FDA press release here.
    Download the Tecentriq ES-SCLC Day 1 Letter here.

    Posted 3/19/2019

  • CMS Updates Drug Dashboards with Drug Pricing and Spending

    On March 14, the Centers for Medicare & Medicaid Services (CMS) updated its Drug Spending Dashboards with data for 2017. The dashboards add information on manufacturers that are responsible for price increases and includes pricing and spending data for drugs across Medicare Parts B and D and Medicaid.

    The dashboards focus on average spending per dosage unit for prescription drugs paid under Medicare Parts B and D and Medicaid, and tracks the change in average spending per dosage unit over time. Information is also provided on drug uses and clinical indications, so patients and physicians can compare the list prices of different medications for a given condition.

    In 2017, total gross spending on prescription drugs was $154.9 billion in Medicare Part D, $30.4 billion in Part B, and $67.6 billion in Medicaid.

    Click here to access the CMS Drug Spending Dashboards.

    Posted 3/14/2019

  • NCI Director Norman Sharpless Appointed Acting Commissioner of FDA

    On March 12, Health and Human Services Secretary Alex Azar told Congress that Norman "Ned" Sharpless, director of the National Cancer Institute (NCI), will become acting commissioner of the Food and Drug Administration (FDA), succeeding Scott Gottlieb. Gottlieb announced his April departure in the first week of March.

    Doug Lowy, current NCI Deputy Director, will serve as acting director of the NCI upon Sharpless' transition to the FDA.

    Read news coverage from STAT here.

    Posted 3/12/2019

  • FDA Approves Trastuzumab-qyyp as Biosimilar to Herceptin

    On March 11, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to Herceptin, for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

    Read the Pfizer press release here.

    Posted 3/12/2019

  • FDA Approves Atezolizumab Plus Nab-paclitaxel for TNBC

    On March 8, the FDA approved atezolizumab (Tecentriq, Genentech Inc.) plus nab-paclitaxel (Abraxane, Celgene) for the frontline treatment of patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer (TNBC).

    Read OncLive news coverage here

    Posted 3/8/2019

  • CMS Seeks Input on Eliminating Barriers to Sale of Health Insurance Across State Lines

    In a March 6 press release, the Centers for Medicare & Medicaid Services (CMS) announced that the agency's issuance of a request for information (RFI) soliciting recommendations on "how to eliminate regulatory, operational and financial barriers to enhance issuers’ ability to sell health insurance coverage across state lines."

    The press release states that the RFI builds on President Trump’s October 12, 2017, Executive Order, “Promoting Healthcare Choice and Competition Across the United States” instructs the administration to facilitate the purchase of health insurance coverage across state lines.

    The RFI will be open for public comment for 60 days.

    View the RFI here.

    Posted 3/6/2019

  • FDA Approves Trastuzumab and Hyaluronidase-oysk for Breast Cancer

    On February 28, the Food and Drug Administration approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech Inc.) for the treatment of HER2-overexpressing breast cancer.

  • FDA Approves Trifluridine and Tipiracil for Gastric/GEJ Adenocarcinoma

    On February 25, the U.S. Food and Drug Administration approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) for the treatment of adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

    Read the Taiho Oncology press release here.

    Posted 2/25/2019

  • FDA Approves Pembrolizumab for Melanoma

    On February 15, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

    Read the FDA press release here.

    Posted 2/19/2019