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Oncology Newsfeed

  • USPSTF Draft Recommendation Expands Those Eligible for LDCT Lung Cancer Screening

    The U.S. Preventive Services Task Force (USPSTF) released a draft recommendation on July 7 that could nearly double the population of those eligible for annual lung cancer screening with low-dose CT. The proposed changes revise the USPSTF high-risk category to include:

    • adults ages 50 to 80 years

    • who have a 20 pack-year smoking history, and

    • currently smoke or have quit within the past 15 years.
    The Task Force issued the recommendation with a "B" grade.

    When finalized, this recommendation will replace the 2014 USPSTF recommendation on annual screening for lung cancer with LDCT in adults ages 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.

    The updated recommendation is open for public comment until 8:00 PM on August 3, 2020.

    The USPSTF is an independent, non-federal, volunteer group of national experts in prevention and evidence-based medicine. The Task Force works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services, such as screenings, counseling services, and preventive medicines. The recommendations apply to people with no signs or symptoms of the disease being discussed.

    Posted 7/7/2020

  • FDA Approves Decitabine + Cedazuridine Oral Combo for Adult MDS

    On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following:

    • previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and
    • intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
    Read the FDA announcement.

    Posted 7/7/2020

  • FDA Approves Avelumab for Maintenance Treatment in Advanced Urothelial Carcinoma

    On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

    Read FDA announcement.

    Posted 7/1/2020

  • FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

    Read FDA announcement.

    Posted 6/30/2020

  • FDA Approves New Fixed-Dose Combination for HER2+ Breast Cancer

    On June 29, 2020, the U.S. Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo, Genentech, Inc.) for subcutaneous injection for the following indications: 

    • Use in combination with chemotherapy as: 
      • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer;
      • adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
    • Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
    Read the FDA announcement

    Posted 6/29/2020

  • CMS Releases Preliminary Data on Impact of COVID-19 on Medicare Population

    On June 23, the Centers for Medicare & Medicaid Services (CMS) released a preliminary snapshot of the COVID-19 pandemic's impact on the Medicare population, based on Medicare claims data.

    The data released today includes the total number of reported COVID-19 cases and hospitalizations among Medicare beneficiaries between January 1 and May 16, 2020. The snapshot breaks down COVID-19 cases and hospitalizations for Medicare beneficiaries by state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations.

    CMS data shows that more than 325,000 Medicare beneficiaries received a diagnosis of COVID-19 between January 1 and May 16, 2020. During this same time period, nearly 110,000 Medicare beneficiaries were hospitalized for COVID-19-related treatment. According to the CMS snapshot released today, Black Medicare beneficiaries were hospitalized with COVID-19 at a rate nearly four times higher than whites.

    CMS data shows that:

    • End-stage renal disease (ESRD) patients had the highest rate of hospitalization among all Medicare beneficiaries, with 1,341 hospitalizations per 100,000 beneficiaries.
    • The second highest rate was among beneficiaries enrolled in both Medicare and Medicaid (also known as “dual eligible”), with 473 hospitalizations per 100,000 beneficiaries.
    • Among racial/ethnic groups, Blacks had the highest hospitalization rate, with 465 per 100,000. Hispanics had 258 hospitalizations per 100,000. Asians had 187 per 100,000 and whites had 123 per 100,000.
    • Beneficiaries living in rural areas have fewer cases and lower rates of hospitalization than Medicare beneficiaries living in urban/suburban areas (57 versus 205 hospitalizations per 100,000).
    Access CMS' Preliminary Medicare COVID-19 Data Snapshot and additional information here

    Posted 6/23/2020

  • CMS Announces New Office of Burden Reduction and Health Informatics

    On June 23, the Centers for Medicare & Medicaid Services (CMS) announced creation of the Office of Burden Reduction and Health Informatics. The new office is intended to consolidate CMS' efforts to reduce regulatory and administrative burden, according to the agency's announcement. The unveiling of the new office, "permanently embeds a culture of burden reduction" across all platforms of CMS operations, the agency said.

    Read the CMS announcement.

    Posted 6/23/2020

  • FDA Approves Selinexor for R/R Diffuse Large B-Cell Lymphoma

    On June 22, 2020, Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio® (selinexor), the company’s first-in-class, selective inhibitor of nuclear export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA’s Accelerated Approval Program.

    Read the corporate press release.

    Posted 6/22/2020 

  • FDA Approves Tazemetostat for R/R Follicular Lymphoma

    On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.

    On the same day, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat.

    Read FDA announcement.

    Posted 6/18/2020

  • CMS: Medicaid NPRM Aims to Foster VBP Models for Prescription Drugs

    On June 17, the Centers for Medicare & Medicaid Services (CMS) released the "Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-P)."

    The agency states that the proposals put forward support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. The proposed rule also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse.

    Read the CMS fact sheet on the proposed rule.  

    Access the proposed rule

    Read HealthAffairs blog by CMS Administrator Seema Verma.

    Posted 6/17/2020